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May–June 2014

52 AMCs Show Renewed Interest in Industry Research: New Collaborations, Greater Trust Breaking Down Research Silos

Karyn Korieth

54 Disclosure and Conflict of Interest Challenges in Investigator-Industry Collaborations

Sue Coons, MA

59 Solo vs Collaborative Scientific Writing Models: Balancing the Advantages and Disadvantages

David E. Vance, PhD, MGS

65 Continuing Education

67 Regulatory Update

EARN 3 CONTACT HOURS IN THIS ISSUE

PRACTITIONERRESEARCH

VOLUME 15, NUMBER 3

AUTHORS

Karyn KoriethMedical Writer, Boston, MA

Sue Coons, MAMedical Writer, Columbus, OH

David E. Vance, PhD, MGSAssociate Professor and Associate Director, Center for Nursing Research, School of Nursing, University of Alabama-Birmingham

EDITORIAL BOARD

Anna J. DeMarinis, MA, CQA(ASQ), MTA(ASCP)SBBPrincipal, The DeMarinis Group, North Attleborough, MA

Lee Ferrell, CCRA, CCRPNA Head, Regulatory and Start Up (RSU), Integrated Site Services, Quintiles, Inc., Research Triangle Park, NC

Terry HartnettMedical Writer, Pittsburgh, PA

Carolynn Thomas Jones, DNP, MSPH, RNFaculty Instructor, University of Alabama Birmingham, School of Nursing, AL

Nancy A. Olson, JDDirector, Institutional Review Boards/Human Research Office, University of Mississippi Medical Center, Jackson, MS

Dónal P. O’Mathúna, BS (Pharm), MA, PhDSenior Lecturer in Ethics, Decision-Making, and Evidence, School of Nursing Academic Member, Biomedical Diagnostics Institute, Dublin City University, Dublin, Ireland

Mark Parascandola, PhD, MPHStaff Writer, Washington, DC

Sandra M. Sanford, RN, MSN, CIPNurse Planner Education and Training Specialist, Human Research Protections Armed Forces Services Corporation, Arlington, VA

Barbara S. Turner, RN, DNSc, FAANChairperson, Doctor of Nursing Program, Professor, Duke University School of Nursing and General Clinical Research Center, Durham, NC

Janet F. Zimmerman, MS, RNAssistant Clinical Professor, Coordinator, Clinical Trials Research MSN Track, Drexel University College of Nursing and Health Professions, Philadelphia, PA

Lynn D. Van Dermark, RN, BSN, MBA, CCRA, RACCEO, MedTrials, Inc., Dallas, TX

MANAGING EDITORLeslie Coplin

EDITOR-IN-CHIEF, CENTERWATCHCheryl Rosenfeld

GRAPHIC DESIGNHolly Rose

COVER PHOTO©iStockphoto.com

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The following editorial board members, Lee Ferrell, Terry Hartnett, Carolynn Thomas Jones, Dónal P. O’Mathúna, Nancy A. Olson, Mark Parascan-dola, Sandra Sanford, Barbara Turner, and Janet Zimmerman hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months. Anna J. DeMarinis reports that her spouse is a full-time employee at Johnson & Johnson. Lynn Van Dermark reports that she is an employee, board mem-ber, and stockholder at MedTrials, Inc.

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52 Research Practitioner | March–April 2014

AMCs Show Renewed Interest in Industry

Research: New Collaborations,

Greater Trust Breaking Down Research Silos

By Karyn Korieth

Key words: academic medical center, clinical research, conflict of interest, Sunshine Act

Learning Objectives:

1. Discuss the shif t in research par tnerships between industry and academic medical centers.

2. List steps taken by academic medical centers to increase the number of par tnerships with industry sponsors.

3. Explain potential conflicts of interest in industry -academic medical center research collaborations.

4. Describe challenges of the Physician Payment Sunshine Act on research collaborations.

A cademic medical centers (AMCs), which have had an uneasy relationship with industry for the past 2 decades, now have a renewed interest in partnering

with industry sponsors for clinical studies and are invest-ing significant resources to improve efficiencies and become more competitive in obtaining industry-sponsored grants.

During the past year, AMCs have begun to feel the impact of massive automatic federal spending cuts — better known as sequestration — and are aggressively pursuing industry-funded clinical trials to diversify their portfolios and develop additional sources of much-needed revenue. Sequestration required the National Institutes of Health (NIH), the lead-ing supporter of biomedical research in the world, to cut $1.55 billion from its 2013 budget, and the agency expects to award 700 fewer competitive research grants this year.

AMCs’ increased interest in industry-sponsored trials also is a result of innovative partnerships with industry that have built new levels of trust and collaboration between pharmaceutical companies and academia. Some agreements include novel intellectual property sharing between the two. As a result, academic centers are more likely to be involved in industry-sponsored trials, particularly costly ones that require large numbers of patients, to move research forward and advance their collaborative partnerships with industry.

“There is a definite frame shift in academic medicine of moving from being solely focused on conflict of interest to being focused on what are some convergence of interest,” said Ann Bonham, chief scientific officer of the Association of American Medical Colleges (AAMC). “I think there is a larger view now that we have to move away from industry being in one silo and academic medicine in another silo. We can’t afford that model today and it can’t move us forward.”

Academic centers have made many failed attempts to work with sponsors in the past, and their commitment to con-ducting industry-sponsored clinical studies has waxed and waned throughout the years. Yet academia’s attitude toward conducting these trials has shifted again. Academic medi-cal leaders are more receptive to working with industry and have begun to consider clinical trials an essential component of research and care. AMCs are working hard to improve their reputation with industry and have made significant investments to improve operational efficiencies for clinical trials. Increasingly, academic researchers recognize that in a resource-constrained environment, in which the number of products reaching the market does not sustain the cost of R&D activities, academic partnerships with industry can play a critical role in bringing new medicines to market.

“Improving processes has brought out an awareness,” said Jean Gatewood, director, Office of Clinical Trials at New York University (NYU) Langone Medical Center, “that be-

May–June 2014 | Research Practitioner 53

yond involvement with industry to earn more money or have another treatment option for patients, the large picture is about how you can really drive things forward and be part of a larger organization working in a more collaborative fashion to really affect some changes.”

Falling Market ShareOver the past 2 decades, AMCs gradually lost market share of industry-funded projects to community-based, for-profit investigative sites. CenterWatch analysis found AMCs conducted about 75% of industry-funded projects in the mid-1990s. Yet, according to the latest data from the Tufts Center for the Study of Drug Development (CSDD), the proportion of FDA-regulated clinical trials conducted by university, hospital, or govern-ment investigators dropped from nearly two-thirds (64%) in 2006 to 47% last year. Meanwhile, more than half (53%) of all FDA-regulated clinical trials now are conducted by independent, community-based principal in-vestigators (PIs); private-practice investigators have taken the lead, for the first time, in conducting the largest proportion of clinical trials globally.

The Tufts CSDD data also show academic sites perform poorly in study startup and patient enroll-ment compared to independent PIs. University, hospital, and government clinics take nearly twice as long to move clinical studies from previsit through site initiation (9.9 months) compared to PIs (5.2 months). The not-for-profit sites also take longer than private physician sites to randomize the first patient and have a lower likelihood of randomizing at least one patient per trial. In addition, a lower proportion of university, hospital, and government clinics (73%) meet patient enrollment targets than indepen-dent physician sites (96%).

The industry began turning to the for-profit research site segment of the market in the 1990s as its development programs became larger and more costly. Sponsors needed to complete these clinical studies quickly and inexpensively but became frustrated by the inefficiencies in academia, includ-

ing lengthy contract and budget negotiations, slow-moving IRBs and higher costs associated with poor performance. AMCs saw their share of industry-sponsored trials decline, while independent physician practices and dedicated research centers increasingly gained market share.

Relationships between AMCs and industry have swung both toward and away from collaboration throughout the years. Many academic institutions established clinical trial offices to better handle industry relationships, but efforts often were stymied by a general lack of institutional support, renewed in-terest in more prestigious government-funded clinical research programs, and ongoing concerns about conflict of interest.

The recent cuts in federal funding for research, however, have caused academic medical centers to rethink their participa-tion in industry-funded trials and make a concerted effort to be more competitive.

“Investigator-initiated studies fund-ed by the NIH have been our bread and butter. As that kind of funding started to go down, we thought we might want to start looking at some of the industry sponsors,” said Jill Malayang, manager of the Michigan Institute for Clinical & Health Research (MICHR) Clini-cal Trials Office at the University of Michigan. “We would like to have a balanced portfolio. That way you can ride out the ups-and-downs of federal government or industry. You don’t want to depend on just one type of funding.”

To win back industry-sponsored trials, in recent years AMCs have improved operational efficiencies to better meet industry needs in a variety of ways, including central-izing trial offices, standardizing

processes, improving trial software and study start-up proce-dures, reducing the amount of time for contract and budget negotiations, using external sources to improve IRB turn-around, and investing in patient recruitment tools. Further-more, some AMCs have developed master agreements with sponsors and formed alliances with other academic centers.

The Medical College of Wisconsin, in one example, began centralizing clinical trial resources at the request of the continued on page 56

Academic medical

center leaders are

more receptive to

working with industry

and have begun to

consider clinical trials

an essential

component of

research and care.

54 Research Practitioner | May–June 2014

T he relationship between industry and academic medical centers (AMCs) may have been strained once, but a 2011 blog article signaled a shift in

tone. The industry buzz phrase is “clear path to clinic,” wrote Nurjana Bachman, then the business development manager in the Technology and Innovation Development Office at Children’s Hospital in Boston.1 And who did in-dustry think knew this path best? Investigators at academic research centers. “This has brought a shift in how industry interacts with academia, and new and equitable partner-ship structures are poised to facilitate joint therapeutic development like never before,” she said.

As the article on page 52 shows, AMCs now have even more interest in industry-sponsored clinical trials. Issues of disclosure and questions of conflict of interest, however, continue to add frustrations to the process.

Government RegulationOne ongoing challenge is the disclosure requirements of the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act is part of the Patient Protection and Afford-able Care Act (Public Law 111-148), a series of health care reform provisions signed into law by President Obama in March 2010. The Sunshine Act was designed to increase the transparency of the relationship between physicians — including clinical researchers — and drug and device manufacturers. However, organizations that advocate for clinical researchers, such as the Association of American Medical Colleges in Washington, DC, have previously told Research Practitioner that the rule could be “misleading and mischaracterizes the relationship between the manufac-turer and the physicians conducting the research,” such as when research payments cover other research-related costs including equipment, diagnostic procedures, support, and research staff time and facility overhead costs.2

“[With] the implementation of the Open Payments process of the Sunshine law, many partnerships may become strained because all payments will be publicly disclosed if provided to a teaching hospital or covered physician,” says Russell Hirschorn, a senior consultant with New York-based Polaris Management Partners, a consulting and technology provider for life sciences companies. “The

biggest challenge we see as a global life sciences compliance consulting firm is the Sunshine Act and reporting all pay-ments and transfers of value. Many health care services or-ganizations and HCPs [health care providers] do not want to show up on the public report disclosing the funds and value transferred to them through various engagements. Research has no exemption from reporting like medical education does, and the investigator will be attributed to the full payment amount as of the current state of the final rule.”

A popular topic at a recent Center for Business Intelligence (CBI) conference for investigator-initiated and sponsored research in Philadelphia focused on the Sunshine Act’s “delayed publication” provision and how it is applied, Hirschorn writes in a blog post. In its final rule, the Cen-ters for Medicare and Medicaid Services (CMS) said that many comments sought to limit the reporting of research-related payment in “significant ways,” such as only reporting direct research. CMS disagreed. “[We] believe Congress clearly intended research-related payments or other transfers of value to be included in the reporting re-quirements, based on the inclusion of ‘research’ as a nature of payment, the statutory definition of ‘clinical investiga-tion,’ and the procedures for delayed reporting for certain research-related payments or other transfers of value. We believe that excluding payments or other transfers of value related to clinical research or indirect research from the reporting requirements would be inconsistent with the intent of Congress.”3

Panel experts further explored the delayed publication at the conference. “We explained CMS’ decision to delay the public display of certain research payments as long as the payment or transfer of value (TOV) is related to research, development, clinical investigations, or a new application of a new drug, device, biologic or medical supply,” writes Hirschorn in his blog. “Delayed publication is not available for the same activities on existing drugs, devices, biologics, or medical supplies. Any payment or TOV data attached to filings receiving a delayed publication indication will be publicly posted on the first reporting date following either the date of approval/licensure or clearance of the Covered Drugs, Devices, Biologicals or Medical supplies by the FDA or 4 calendar years after the date the payment/TOV was made, whichever comes first.”

Disclosure and Conflict of Interest Challenges in Investigator-Industry CollaborationsBy Sue Coons, MA


The Issue of Fair Market ValueFair market value (FMV) was another hot topic at the con-ference, organizers say. As Hirschorn writes in Polaris’ blog about the conference, “By far the greatest interest among session participants was shown in determining FMV for [investigator-initiated sponsored research]. We made the point that there is no magic number for [investigator-initi-ated trial] FMV evaluation, and that the key is implement-ing a consistent and repeatable process for all companies, investigators, and studies.”4

Alexander Kostek, Team Global IIR [Investigator-Initiated Research] Group Leader for Pfizer Inc. in New York, says he doesn’t see the disclosure requirements as being a limit-ing step. “If fair market value is being conducted or appre-ciated by all parties, then there should not be any concern with the disclosure.” The disclosure is a legal requirement, he adds. “I think fair market value is something that can assist in that.”

“[It helps] being transparent as to what the expectations are regarding fair market value and being able to under-stand what is driving costs. What is the driver behind a certain cost by a researcher or facility, let’s say, compared to other costs in the same region for the same activity?” Kostek says. According to its website, Pfizer has “re-searched wage data for health care professionals to deter-mine the ‘fair market value’ for compensating its partners.5 These data, the company says, tell the company what health care professionals “would actually earn for their time in practice, based on their specific credentials and qualifications.” Pfizer then says it uses this information “to ensure each health care professional’s compensation is fair and reasonable for the amount of time necessary to provide the requested service.”

“Industry-wide, most organizations are very aware of the need for [health care providers] payment fair market value,” Hirschorn says. “Something that is becoming more popular is FMV for visits/procedures and other costs as-sociated with a trial.”

Conflict of InterestAnother problem with the partnerships between AMCs and industry is the issue of conflict of interest. An April 2 research letter in the Journal of the American Medical Association pointed out the potential conflict regarding research conducted at an institution when the leader of the AMC sits on the board of a pharmaceutical company.6

Researchers at the University of Pittsburgh School of Medicine looked at 2012 year-round board members from the world’s 50 largest pharmaceutical companies. The researchers were not able to look at three of the companies’ boards. Of the rest, 19 had at least one board member who also held a leadership position at a U.S. academic medical center, including 16 of the 17 U.S. companies.7 Eighteen industry board members, or 3% of all board members, held 21 clinical or administrative leadership positions at academic medical centers. These included two university presidents, six deans, six hospital or health system execu-tive officers, and seven clinical department chairs or center directors. Compensation to the board members averaged $312,564 by the pharmaceutical companies, although it was not said whether the board member or the institution received the money.

Having AMC leadership on the board of a pharmaceuti-cal company could help and hurt, according to the study’s senior author. “These board ties could be potentially worthwhile for both sides and their institutions’ goals, including helping universities find out about industry funding available for research,” said Walid Gellad, assistant professor of medicine at the University of Pittsburgh, in an interview with the Associated Press. “But the ties may also open the door to additional industry influence over important medical center or university decision-making, and may negatively influence the perceptions and trust of patients, students, and the public. These risks have to be considered alongside any potential benefits.”8

The study did not name the board members, but the AMCs listed quickly defended their leadership, saying they strictly followed the institutions’ conflict of interest poli-cies and that the board members did not make decisions regarding clinical trials. So would research resulting from an AMC-industry partnership have the conflict of interest question attached to it? Some say that being on the board lets AMC leadership have a “watchful eye” on the com-pany.9 Others are more skeptical. “I don’t know how they can manage a conflict like that,” said Susan Chimonas, an expert on conflicts of interest in medicine and associ-ate director of research for Columbia University’s Center on Medicine as a Profession in New York, NY. “My gosh, there is so much money they are making for a little side job.” Chimonas, who spoke to the Milwakee-Wisconsin Journal Sentinel, added that “serving in dual roles raises so many potential conflicts that it would be wiser to elimi-nate them.”10

Paul Levy, the former president and CEO of Beth Israel Deaconess Medical Center in Boston and now senior adviser at Lax Sebenious LLC in Concord Mass., looked at


continued from page 53 faculty members who wanted to maintain the option of industry-sponsored clinical research. “This is being done to standardize the regulatory requirements of the trials and to obtain economies of scale with regard to personnel required to manage and conduct such trials. We also invested in a comprehensive software solution for conducting clinical trials,” said David Gutterman, senior associate dean for research at the college.

Kimberly Irvine, executive vice president and chief operat-ing officer of the Biomedical Research Alliance of New York (BRANY), which includes four nationally ranked academic centers, said many organizations are going through internal analyses or using a consulting firm to find ways to improve the efficiencies of their programs and find the best ways

to carry them out. “They are looking at how they can help the investigators make better decisions about clinical trials and putting systems into place so they can meet the goals industry sponsors are setting,” she said. “The one theme I am hearing, even from investigators, is that the institutions are working to make sure the processes are happening in parallel with an awareness of a timeline. If they can’t be efficient and get things done on time, they are not competitive. I think sponsors are responding to that.”

The NYU Langone Medical Center, in another example, began an initiative to grow research opportunities with in-dustry even before the recent wave of budget cuts, as part of an effort to develop a more balanced portfolio. The medical center hired Gatewood, who had experience working both in industry and at an academic medical center, to revamp the clinical trials office, which oversees financial management

the issue critically as well. The AMC leadership is involved in business decisions and corporate partnerships, he told the Journal-Sentinel. “You cannot serve two masters, even if you are highly intelligent,” he said. “In fact, if you are highly intelligent, you will rationalize the problems away by saying that you cannot be personally corrupted.”

In a February 2012 article in Genetics in Medicine, researchers discussed navigating a partnership between academicians and industry, including how they developed a framework for collaboration. They said this about man-aging conflict of interest:

[The] existence of a conflict of interest does not mean that the industry scientist or academic researcher has in-tentions that are at odds with the goals of the research. What it does mean is that a clearly specified and transparent framework for minimizing the introduction of bias should be developed and adhered to throughout the study. To this end, it is critical to provide an a priori framework for identifying, analyzing, and managing unforeseen issues as they emerge over the course of a study.11

Even with disclosure issues, collaborations between AMCs and industry can be valuable, according to authors in a 2011 article in Nature Medicine.12 “Fully disclosed and carefully managed research collaborations can be very valuable to academic medical centers, industry, and the public,” they said. “Eroding trust is not a necessary side effect: Relationships should be disclosed not as scarlet letters but as medals of pride. Those capitalizing most on academic-industry collaborations are more likely to improve public health through new discoveries, a major accomplishment and the truest measure of success for the biomedical research enterprise.”

References1. Bachman N. Big pharma’s changing business model: Inviting academia to take the lead.

Vector. Boston’s Children’s Hospital. August 24, 2011. Available at http://vectorblog.org/2011/08/big-pharmas-changing-business-model-inviting-academia-to-take-the-lead/.

2. Hartnett T. Attention Research Physicians: Study sponsors soon to track and report payments as part of Affordable Care Act. Research Practitioner 2012;13:199-205.

3. Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Report-ing of Physician Ownership or Investment Interests. Federal Register 78;27:9458-9528.

4. Hirschorn R. CBI Conference Highlights: Lots of questions about research study spend capture and reporting. Polaris Insights Blog. April 9, 2014. Available at http://blog.polarismanage-ment.com/2014-cbi-investigator-initiated-and-sponsored-research-iisr-highlights.

5. Fair Market Value. Pfizer. Available at http://www.pfizer.com/responsibility/work-ing_with_hcp/fair_market_value. Accessed May 1, 2014.

6. Anderson TS, Dave S, Good CB, et al. Academic Medical Center Leadership on Pharmaceutical Company Boards of Directors. JAMA 2014;311(13):1353-1355.

7. Ties Between Big Pharma and Leaders of Academic Medical Centers Raise Conflict-of-Interest Questions. UPMC/University of Pittsburgh Schools of the Health Science. April 1, 2014. Available at http://www.upmc.com/media/NewsReleases/2014/Pages/big-pharma-ties-academic-medical-centers-conflict-of-interest.aspx.

8. Lindsey Tanner. Health Leaders On Drug Company Boards: A Conflict? Associated Press. April 2, 2014. Available at http://www.huffingtonpost.com/2014/04/02/health-leaders-drug-company-boards-conflict-of-interest_n_5076632.html.

9. Conflict of interest: Leaders of academic medical centers serving on pharmaceutical boards. Science 2.0. April 1, 2014. Available at http://www.science20.com/news_articles/conflict_of_interest_leaders_of_academic_medical_centers_serving_on_pharmaceuti-cal_boards-132825.

10. Fauber J. Watchdog update – Medical school leaders cash in on drug company boards. Milwaukee-Wisconsin Journal Sentinel. April 1, 2014. Available at: http://www.jsonline.com/watchdog/watchdogreports/medical-school-leaders-cash-in-on-drug-company-boards-b99237232z1-253425641.html.

11. iLehmann SL, Kaufman J, Sharp RR, et al. Navigating a research partnership between academia and industry to assess the impact of personalized genetic testing. Genetics in Medicine 2012;14:268-273.

12. Johnston SC, Hauser SL, Hellmann SD. Enhancing ties between academia and industry to improve health. Nature Medicine 2011;17:434-436.


and contracts for both industry and government research grants.

Since Gatewood took over the clinical trials office 5 years ago, the medical center has doubled its business with indus-try and now has about 2000 clinical research studies open. The success was due to a variety of measures, including working with legal counsel to define clearer policies, creat-ing more streamlined processes for clinical contracting and confidentiality disclosure agreements, developing relation-ships with preferred sites, and entering master clinical trial agreements with industry spon-sors to help reduce contracting timelines. The average timeline to negotiate a contract has been reduced from 8 months to a 90-day turnaround; Gatewood said the office is moving toward a 60-day timeline.

Gatewood collects metrics mea-suring clinical research perfor-mance, which the medical center uses in business development ef-forts. “Rather than being passive, we have asserted ourselves and collect metrics. We have a busi-ness presentation that we share when sponsor organizations come to share with us informa-tion about their pipelines and opportunities available. We also have a presentation that shows where our clinical expertise lies. It explains our processes and why we should be a preferred site,” she said.

At the University of Michigan, whose clinical trials office opened 2 years ago as part of the MICHR to support startup of industry-initiated clinical tri-als, the review of industry-sponsored studies has been turned over to a central IRB, which can speed approval times and offer efficiency.

Drexel University College of Medicine is among other aca-demic centers that use a central IRB to review and approve most industry-sponsored multicenter trials. Sponsors have long bemoaned that approvals from university IRBs take too long; some companies will no longer work with AMCs that can’t use a central IRB. “It’s also good for our investigator studies because it will clear our University of Michigan IRB to deal with those studies,” said Malayang.

Many AMCs have become more competitive by moving

toward a multicenter model that partners with other aca-demic centers, community hospitals, or private physicians for clinical trials to improve their ability to enroll a greater number of patients more quickly. “Academic medical centers aligning with community-based sites also have an opportu-nity to carry out clinical trials more effectively,” said Irvine. “They rely on more organizations to fulfill an enrollment target because they are spanning a wider network of patients. Those all are important pieces that academic medical centers have to offer.”

Another approach includes forming alliances that can help institutions streamline processes and improve their ability to compete for industry grants. BRANY, for example, offers support services for sites to help ac-celerate timelines and operates a cen-tral IRB that can provide review for multicenter research projects. And the NYU Langone Medical Center has collaborated with the Memorial Sloan Kettering Cancer Center on an initiative for academic research administration called the New York City Office of Clinical Trials consor-tium. The 13 members, all from nearby academic health centers, meet to discuss ways to improve the opera-tion and administration of clinical research, particularly as it relates to industry studies.

“We’ve learned a lot from each other and now we actually challenge each other about who can get contracts done faster,” said NYU’s Gatewood.

Partnerships on the RiseBy reducing the bureaucracy inherent in university medical centers and improving efficiencies, academic sites have be-come more attractive R&D partners to sponsors and contract research organizations (CROs), who want to improve study timelines and reduce costs. Big pharma companies have begun collaborations with academic institutions that support discovery from the laboratory through early clinical trials with the same academic team. These partnerships, which help build trust between industry and academia, represent a major shift from the traditional short-term, transactional relationships that would end once a project was completed. AAMC’s Bonham believes these new relationships will help advance participation of academic centers in clinical trials.

Big pharma

companies have

begun collaborations

with academic

institutions that

support discovery

from the laboratory

through early clinical

trials with the same

academic team.


“There was a time when we heard queries like, ‘Is it ethical to partner around this research?’ Now we are hearing questions of when would it be unethical not to partner for the spon-sored clinical trials. There is a definite shift,” she said.

According to an analysis from Citeline, which tracks R&D trends for industry, the number of partnership deals be-tween pharmaceutical/biotech companies and academia has increased 14.5% since 2011; those deals include all phases of drug development, from research through marketing. However, Citeline found the average deal value fell from $4.7 million in 2011 to $4.3 million in 2012.

Major CROs also are pursuing strategic partnerships with AMCs that allow them access to large patient populations for clinical studies and clinical expertise. For the AMCs, these agreements provide additional revenue, a more regular flow of study work and, in some deals, first-hand clinical trial experience for their students.

Quintiles, for example, launched its Prime Site program in 2007 to develop strategic relationships with AMCs, large hospitals, and health care systems capable of enroll-ing hundreds of trial participants each year. The partner-ships give Quintiles access to large patient populations and clinical expertise across multiple therapeutic areas, while the sites receive access to the CRO’s largest studies before they are offered to other sites. Through the Prime Site program, Quintiles has partnerships with AMCs in the United States and around the world, including the University Malay Medi-cal Center in Kuala Lumpur, Malaysia; the University of Pre-toria, South Africa; the Seoul National University Hospital; and the University of Nebraska Medical Center.

Parexel International also has begun establishing partner-ships with AMCs globally. Last year, it entered into an agreement with the National Taiwan University Hospital to provide drug development services in the country. Earlier this year, it teamed with Rutgers New Jersey Medical School (NJMS) in a long-term deal that allows the CRO to place early to late phase studies at the school’s clinical research center and access data through the NJMS electronic medical records system.

“The agreement with Parexel exemplifies the university’s en-hanced commitment to collaborate with industry,” said Ken-neth Breslauer, vice president for health science partnerships at NJMS, which became part of the newly created Biomedical and Health Sciences center within Rutgers. “This partnership further enhances the global research, educational, and service missions of the new Rutgers Biomedical and Health Sciences unit as it strengthens both our clinical research capabilities and our potential to enhance healthcare delivery.”

AMCs have begun to actively pursue these growing partner-

ships with CROs as they try to strengthen portfolios with industry-sponsored studies. “There is strength that comes with having these strategic partnerships and creating rela-tionships,” said BRANY’s Irvine. “I view that as important.” BRANY joined Quintiles’ Prime Site network earlier this year. “There are benefits to having those relationships. They are a lot more collaborative and there is a desire from all par-ties to hit the targets.”

The NIH also has helped prompt AMCs to expand their involvement in industry-funded trials. In order to continue receiving federal funding from the NIH’s Clinical and Translational Science Awards program, academic institutions must attract more industry studies. Other grants specifically require an academic center to work with an industry partner.

At the same time, sponsors and CROs are turning to academia for Phase 1 research to fill the void left by major CROs, including Covance and Quintiles, restructuring their early development capabilities. In September, Covance partnered with the Indiana Clinical and Translational Sci-ences Institute (CTSI), part of the Indiana University School of Medicine, to conduct early trials on behalf of biotech and pharma companies. Covance also has an exclusive agreement with the Royal Liverpool and Broadgreen University Hospi-tals NHS Trust to conduct early clinical trials.

Rob Aspbury, vice president and general manager, global clinical pharmaceutical services at Covance, said the alliances help provide biopharmaceutical clients with quicker access to patients in hospital settings that support specialized care and monitoring. “With quicker access to patients, we can stream-line the drug development process and bring important new medications to the patients who need them,” he said.

Looking AheadRising financial pressures will spur more AMCs to expand their involvement in industry-funded clinical trials over the next several years. Increasing partnerships with both sponsors and CROs will help boost AMC commitment to working with industry on clinical studies. In addition, as AMCs work to improve operational efficiencies and speed up timelines, they will become more attractive as clinical trial sites because of their access to large patient populations and therapeutic expertise.

There is a growing recognition of the need for academia to collaborate with industry in order for both sides to succeed. “There are a lot of associations and partnerships that didn’t exist two decades ago,” said AAMC’s Bonham. “It really makes sense to be taking advantage of the skills and value that your partner brings.”

March–April 2014 | Research Practitioner 59

Solo vs Collaborative

Scientific Writing Models: Balancing

the Advantages and Disadvantages

By David E. Vance, PhD, MGS

Key words: collaborative writing, publication, scientific writing, solo writing, team writing

Learning Objectives:

1. Discuss advantages of collaborative scientific writing.

2. Discuss advantages of solo scientific writing.

3. Describe scenarios that follow various writing models.

4. List pointers, caveats, and contribution considerations of scientific writing models.

A lthough science is a team endeavor, scientific writ-ing typically is a solitary activity, especially in the initial stages.1-4 Even those with a wide range of

medical and research acumen (i.e., statistical, biological, psychosocial) must reach out to others for help in writing an article. It is unlikely that a single researcher will have all the necessary scientific knowledge and skills to write numerous articles that will advance the science. Scientific knowledge is constantly advancing, which makes it impos-sible to keep abreast of all new discoveries and innovations.5,6 As a result, it is important for authors to turn to others for insights, expertise, and clarity about a research topic. Often, a cross-disciplinary team of experts can collectively produce a scholarly paper that will impact the scientific community for years to come.4,7,8

When deciding whether to write a study alone or as part of a group, a researcher may consider the following:

■■ Should I be writing in a team since science is a team endeavor?

■■ Do I possess the appropriate skills to write this article on my own or do I need expertise from others?

■■ When should I invite someone with expertise to be on my article?

■■ Since I’ve never published before now, who should I ask for help?

■■ Would it be faster to write with a team vs writing by myself?

Evaluating Solo vs Collaborative Writing ModelsTable 1 provides a framework for understanding the various writing models and evaluating the advantages and disad-vantages of collaborative vs solo writing. Several interrelated factors — authorship order, workload, process control, coordination of people, speed of completion, and quality control — are affected by the various levels of coauthor in-volvement.1 Each of these factors is influenced by the level of involvement by other coauthors within each of these writing models. Thus, as some factors are improved in the writing process, others are worsened. Therefore, a balance of the models will help ensure that an accurate scholarly article is written in a timely, stress free-manner.

Authorship Order. One of the primary rewards of writ-ing is authorship, which is used as a rubric to gage scholarly productivity and career success.1 Authorship order indicates the ordinal credit (and responsibility) due to each author for the content of the article. In most cases, the first author is


automatically deemed the most influential contributor to the article. The first author usually spearheads the ideas, orga-nizes or recruits coauthors, and directs the overall flow and content of the article. Generally, each subsequent author has less involvement and provides less input regarding content.

However, there are exceptions to this convention of author-ship order. In many medical and scientific journals, the last named author may be the senior researcher on the writing team who helped guide the first author, so this position of-ten carries particular significance. In some cases, the reader can assume the research study is ultimately the “brain child” of the last author, who allowed data from his or her study to be analyzed by the first author.

Being the sole author can be rewarding because all the merits belong to one person. In some ways, this is considered more prestigious than serving as the first author of a paper written by a team of coauthors. Solo authorship carries much more

responsibility because all the work is done by one person and all of the faults and errors also are attributed to this sole au-thor. Thus, there is a level of accountability (responsibility) for what is written, so the sole author must be very knowl-edgeable and have an exquisite eye for details.

Workload. Workload is another factor to consider when deciding whether to collaborate with a writing team.1 When working alone, the sole author generates the idea, reviews scientific literature for relevant references, organizes the information, executes the synthesis or study, and analyzes the literature or raw data. The sole author must then write, edit, and fact check the article, all of which can be daunt-ing for a single person. Although usually rewarding, this process also represents an enormous effort for one person. For this reason, it can make sense to seek help from others when conducting the literature review, analyzing the data, or interpreting the findings for a particular discipline.

Table 1: Advantages and Disadvantages of Solo vs Col laborat ive Writ ing Based on a Continuum of Involvement and Col laborat ion

Writing Models with Various Levels of Coauthor Involvement

Factors Affected by Various Levels of Coauthor Involvement

Sole Author of the Article

Invited Others to Review and Modify

Invited Others to Write Select Sections

Everyone Writes a Different Section of the Article

Invited to Collaborate and Write a Section of the Article

Invited to Review and Modify the Article

Authorship Order (amount of credit and responsibility)

First author

First author

First author

Authorship to be determined

Coauthor (position to be determined)

Coauthor (position to be determined)

Workload (effort extended)

Very heavy Very heavy Heavy (but variable)

Moderate (but variable)

Easy Very easy

Process Control (overall direction of the article)

Absolute Very great Great Little Some Little

Coordination of People (organiza-tional skills)

None Little Moderate Extreme Moderate Little

Speed of Completion (how fast is the article written?)

Fastest (probably fast if solo author is motivated)

Variable (probably fast)

Variable (probably slower)

Variable (prob-ably slowest)



Quality Control (accountability of content)

Little (dependent on solo author’s expertise)

Some (but vari-able)


High (but varaible)


Some (but variable)

Note. All of these factors affect each other with an advantage in one factor resulting in a disadvantage with another factor. In addition, these are general guidelines and the outcomes of such factors are variable and dependent on personal and group dynamics.


Process Control. Process control refers to the ability to remain true to an article’s original vision and purpose as well as the ability to maintain and coordinate the many tasks required to prepare an article for publication.1 If one person is doing most of the work, then one person is in control of the process. As the writing team expands, the lead author re-linquishes some responsibility, so it is important to maintain control of the article focus. A lack of leadership and vision can result in too many tangents in the article that cannot be easily remedied into one coherent unified voice.

Coordination of People. It may be helpful to divide the work when generating an article, and this coordination requires planning, time, meetings and correspondence, managerial and organizational skills, and finesse to motivate others to contribute in a timely manner. These efforts can be particularly burdensome when working with doctoral students and junior faculty who may lack the experience with writing for publication in general; in such cases, it may be helpful to provide coauthors with an outline and a writing sample. Although there are disadvantages to team writing, outside experts may be necessary to transform a mediocre article to an article worthy of publication.

Speed of Production. Involving coauthors may delay the speed of production. One inherent tacit goal is to produce a scholarly article as quickly as possible.1 A sole author is in control of the writing process and can complete the article in a brief amount of time if motivated. In team writing, speed of production may be delayed because of multiple reasons, including if someone gets sick or if someone is assigned extra duties at work. However, if the coauthors are highly motivat-ed and each write a section of the article quickly, collectively they may be better at generating a high-quality article in a shorter amount of time because they have effectively shared the workload. It is important to be aware that enlisting coauthors who are involved with other clinical and research endeavors may slow the writing process.

Quality Control. Quality control refers to the degree to which the information contained in the article is accu-rate, useful, and easily conveyed in the writing style itself.1 Although a sole author can ensure quality control if he or she has expertise in the content area, having others involved with the writing process provides an extra degree of quality control and can help prevent mistakes from being published. By relying on others with expertise outside of one’s own scope of practice, however, one loses control over whether the information provided by others is accurate. Unfortunately, even if one relies on another’s expertise with the appropriate credentials (e.g., PhD, RN, MD, PT), if such contributions to the article are inaccurate or unsubstantiated, all of the au-thors are considered culpable, which relates back to account-ability and credit/responsibility for authorship.

The Continuum of Solitary and Collaborative Writing

In general, team writing is preferable for several reasons. First, a sole author may not have the required skills and ex-pertise to tackle a complex issue. Therefore, writing with oth-ers who possess additional insights and acumen allows one to further advance the science. Second, grant reviewers examine proposals to determine if the team members on the grant have published together. If the team members previously have published together, this demonstrates previous produc-tivity and collaboration, and reviewers favor grants that will have a high chance to produce and disseminate study results through scientific articles. If members on the grant have not published together previously, grant reviewers may wonder whether the principal investigator and co-investigators can work together well and be productive in disseminating study results. Finally, writing with others is an excellent way to net-work professionally and can lead to future opportunities to serve as coauthors, to speak at conferences, to serve on com-mittees for professional organizations or review groups, or to consult or collaborate on a grant. Despite these advantages, several disadvantages may make one more inclined to write alone. These advantages and disadvantages are listed in Table 1 along the continuum of the various writing models with different levels of coauthor involvement.1

Sole Author of the Article

Sole authorship of an article is an esteemed distinction on any curriculum vitae, and it demonstrates content expertise, writing skill, motivation, and determination. This can be helpful for promotion and tenure because it demonstrates one’s commitment to the field as well as the ability to be an independent thinker. Other advantages to being a sole author include there is no argument as to authorship order, there are no schedules to coordinate, ultimate control of the article is maintained throughout the writing process, and the article can be produced as speedily as one likes. Quality control can be both an advantage and disadvantage. For example, if the article is well received and is published as the featured article in a publication, the sole author receives the praise. However, if there are problems with the article (e.g., inaccurate infor-mation reported, retraction issued by the journal), then the sole author bears the entire responsibility and professional shame. Finally, being a sole author means doing all of the work involved in writing and handling all of the production details such as managing references, developing tables and figures, corresponding with the editor, and responding to peer reviewers’ comments.


Inviting Others to Review and Modify an Article

Another model involves composing an entire article and then inviting key coauthors with unique expertise to critique the article and add, delete, or clarify sections. For example, for an article that instructs nurses how to diagnose and address neurological problems in HIV patients, it would be helpful to invite nurses who provide care to HIV patients to review the first draft and make comments.9,10 These nurses can critique the article, identify gaps, and suggest modifications that make the article more applicable. Although the first author still bears the brunt of the workload up front, the advantages of this model of writing are that the authorship order is clearly defined, coordination of people is minimal, the lead author retains control of the product and process, the speed of completion is probably very fast, and some quality control is provided by including others with expertise.

Invite Others to Write Select Sections of the Article

As the lead author, one may outline an article and assign sections to other authors with expertise in the subject mat-ter. Increasing the level of involvement of the coauthors has both advantages and disadvantages as well. The lead author remains the first author but authorship order of the other coauthors will have to be determined. Some sections may re-quire more work than others; therefore, those who contribute more should be closer to the first author position than others. Unfortunately, at the outset of writing the article collectively, it may not be clear how much work will be involved for each of the coauthors. An acceptable strategy for handling this conundrum is to inform the writing team in the beginning that authorship order will be determined by the lead author after all of the sections have been completed and the article is proofed by the team. At this point, the lead author will have a better perspective of who contributed the most during this process and can then make an informed decision as to how to structure authorship order of the coauthors.

Workload is distributed more evenly in this writing model and the lead author still maintains a great deal of control over the direction and purpose of the article. However, this model requires more coordination and communication with others. Since people have different writing styles, the lead author will spend additional time editing the various sections so the article has one coherent voice. The article could be delayed if a coauthor is late submitting his or her section or sends a poorly written contribution. Fortunately, an advan-tage of this writing model is that there is a moderate amount of quality control provided because others have collectively provided their expertise.

Everyone Writes a Different Section of the Article

This writing model is not used often because typically the

lead author is determined a priori in many large studies and presentation/publication committees.11 Having a designated leader to coordinate the efforts of the other coauthors is effective in determining the course and speed of produc-tion. If a lead author is identified in advance, there may not be a clear distinction at the end of the writing process as to authorship order, which can lead to interpersonal conflicts. Otherwise, the advantages and disadvantages of this model are similar to the previous model.

Being Invited to Be a Coauthor

If someone is invited to collaborate on a colleague’s article, that person would not be the lead author. However, the burden of the workload, process control, and coordination of people can fall upon this individual. Being an invited coau-thor is an honor, so one should try to complete the writing in a timely manner, participate in the final review of the article before it is submitted for publication, and ensure the best quality of the content to assist the lead author.

ScenariosEach of these writing models can result in a high-quality article that is well-received by the scientific community or a lower-quality scholarly article, depending on the author and/or coauthors’ expertise, motivation, ability to work together, and the vision of the article. To clarify the advantages and disadvantages of collaborative scientific writing, the follow-ing scenarios provide a stark contrast in writing.

Scenario 1 – The Bad Example. Nancy, Ted, and Kim all work in the same department in a nursing school. The department chair suggested they form a writing group to publish and eventually apply for promotion. Nancy is a pedi-atric nurse, Ted is an oncology nurse, and Kim is a palliative care nurse. They decide to write a review article on pediatric oncology palliative care, and meet periodically to discuss the focus of the article. After a few weekly deliberations, they narrow the topic to discuss medication for pain management in pediatric leukemia patients. They determine that each will write a few pages on the topic. They meet two months later to review each other’s work. Nancy drafted a 20-page, first-person, “stream of consciousness” article that included her personal experiences and opinions about certain pain medications in children. Ted wrote a five-page, third-person summary of the pros and cons of oxycontin, hydrocodone, and morphine use in children with different types of cancer, following the American Psychological Association (APA) referencing guidelines. Meanwhile, Kim wrote two pages about the demographic profile of children with leukemia and two pages about the economic and emotional costs of caring for children with leukemia. Kim’s writing style switched


between first and third person and past, present, and future tense, and she followed the American Medical Association referencing guidelines.

The team decided to use some of Kim’s narrative in the introduction, Ted’s five pages as the main body of the article, and some of Nancy’s relevant points as a case scenario and conclusion. They submitted the manuscript to a journal that follows the APA referencing guidelines. Nancy reluctantly reformatted her references to match Ted’s references. Since everyone had written a section, they could not decide who should be designated the first author. They finally agreed that whoever submitted the article and handled the cor-respondence with the journal and the review process would be listed as first author. Nancy and Ted had never submit-ted an article for publication so Kim submitted the article to the journal. Unfortunately, Kim lacked understanding of the importance of consistent tense and person voice, so these style issues remained in the article and ultimately resulted in an unflattering review.

Commentary on Scenario 1. It is not uncommon for department chairs to mentor staff who collaborate on writ-ing projects; sometimes this works well but, in general, it is better if authors are self-motivated and seek each other’s expertise. Although they eventually developed a topic for the article that was germane to their interests and expertise, they failed to work well together by not generating a detailed outline and assigning sections accordingly. Likewise, if they had identified a journal in advance, they would have known how to structure the article and what referencing convention to use. Finally, designating a group leader or a lead author to direct the efforts of the others could have prevented wasting time and effort, such as Nancy writing 20 pages of irrelevant material. This group leader also could have been designated as the first author to help maintain the focus and direction of the article throughout the writing process.

Scenario 2 – The Good Example. Fred, Ginger, and Lucy are all assistant professors at the same university. Fred is a psychologist in the nursing school and has an idea for an ar-ticle that he has already titled, “Cognitive Reserve in Adults with Multiple Sclerosis: Implications for Nursing Practice.” He has targeted a nursing journal that uses the APA referenc-ing guidelines. He developed a working outline and e-mailed it to Ginger, a psychiatric nurse, and Lucy, a neurologist specializing in multiple sclerosis. He informed them that he would draft the article and ask for their feedback as contrib-uting coauthors. He asked Ginger to review the implications for nurses and asks Lucy to review the remaining content. Both Ginger and Lucy accepted. Lucy also edited the outline and suggested a few more points for Fred to consider when writing the first draft.

A few weeks later, Fred sent a well-developed working draft

to Ginger and Lucy to review and modify and asked for feedback within 3 weeks. Within 2 weeks, Ginger returned the article and asked for clarification on some sections, and provided three additional paragraphs about implications for nursing practice. Four weeks later, Lucy returned the article with several editorial comments about how to improve the article. Lucy also added paragraphs on the impact of multiple sclerosis on cognition and provided more current references to support the points made in the article. Fred incorporated their suggestions and returned the article to them for ad-ditional review. A week later, Ginger made a few editorial changes and clarifications, and sent it back to Fred exclaim-ing she was pleased with the changes and did not need to see it anymore. Two weeks later, Lucy returned the article to Fred with a few editorial suggestions additional relevant ref-erences. She also rewrote a paragraph on neurotransmitters. Lucy also gave Fred permission to submit the article at this point. He incorporated their suggestions and submitted it for publication. A few months later, he received relatively favor-able reviews from the journal, with instructions to revise and resubmit. He was able to address most of the comments from the reviewers. He asked Ginger and Lucy to address several comments, and they both responded quickly. Fred then returned the revised article to the journal, where it was ac-cepted for publication with no additional revisions required.

Commentary on Scenario 2. In this optimal scenario, Fred was highly motivated and focused on what he wanted to write. To expedite the production of the article, he chose to do most of the work involved, but he reached out to others with expertise to strengthen the content and communication to the target audience. Providing an outline in the invitation to the coauthors allowed these individuals to determine the merits of the proposed article so they could judge whether they wanted to be involved. The outline also allowed the coauthors to provide feedback in the initial planning stage, which provided more intellectual investment in the article. Providing a deadline for when their contributions were due also helped move the article along to completion.

General PointersClearly, all of these types of scientific writing models have merit; however, each requires particular skill in making them effective in producing an article. As such, a few pointers and caveats, including organization, cognitive load, and contri-bution considerations, should be considered when deciding which model may be best.1

Organization

Numerous steps must be taken develop an idea into a schol-arly article. Since missteps can occur at any point — such as


reviewing the literature, logical presentation of ideas, writing style, selecting the most appropriate journal outlet, and responding to reviewers’ comments — organization is the key to preventing such missteps. An effective group leader (usually the first/lead author), a well-developed outline, and deadlines are the tools for such organization.

The lead author can remind coauthors of deadlines, provide feedback as needed as coauthors write their sections, provide instruction on tense and referencing format, and help negoti-ate conflicts that may arise in the group. Often a novice coauthor may need more assistance with writing, so the lead author may need to serve as a mentor. A well-developed out-line can help the lead author maintain the focus of the article so that coauthors know precisely what to write. Outlines also help prevent coauthors from drifting into tangents. The lead author can use the outline to assign sections to the coauthors to write.

With multiple coauthors come multiple writing styles and in-terjections that can create confusion for the reader. Introduc-ing different writing styles may reduce clarity and compre-hension of the content conveyed in the article. Thus, even if the information in the article is accurate and noteworthy, how it is communicated may confuse the reader. Therefore, the lead author must be effective at blending the different styles into one coherent voice.12

Cognitive load refers to the mental resources required to process information.12 An article that requires the reader to memorize 15 acronyms places a burden on readers who have remember the meaning of these acronyms.12 The human mind can only maintain 5 to 7 discrete units of information in working memory at any given time. It is important in scientific writing to keep the writing style simple and plain, avoid numerous unnecessary acronyms, and introduce con-cepts slowly and methodically so that readers can follow the authors’ “train of thought” effectively.12

In developing a single coherent voice for the article, the lead author should be upfront with the coauthors and should specify how to structure their sentences (e.g., third person, APA referencing) and should provide a writing sample. It is the lead author’s responsibility to carefully edit the article so that the writing style is consistent throughout. This may

require contacting the coauthors to ask for clarifications or details on their assigned sections. It is important to reduce the cognitive load for the reader, including the journal reviewers, so that the article will be easily understood, favor-ably reviewed, and ultimately accepted for publication.

Contribution Considerations

Although there are some gray areas as to what constitutes coauthorship, it should be made perfectly clear that this requires a substantial intellectual addition to the article.13 Formatting, simple editing, and fixing references, although helpful, does not constitute “authorship.” In addition, a cursory review of an article by an expert who responds, “This looks good to me; no comments” is not worthy of coauthor-ship.1 Much more is needed to count as a significant intel-lectual contribution for authorship. Intellectual feedback is required in several forms such as contributing to the outline, providing additional content to the article, data analysis, data interpretation, and suggesting implications for practice and research; most of the time, this involves actual writ-ten sections that are cut and pasted into the article.1,13 Also, involvement in selecting the journal and/or assisting with the peer review process is an unwritten duty of coauthorship. It is important to be cognizant of this to avoid situations where someone thinks he or she contributed to the article when in fact, he/she did not.

References1. Vance DE. To write alone or not to write alone, that is the question. Nurs Res Rev 2013;3:

43-46.2. Bakas T, Farran CJ, Williams LS. Writing with a collaborative team. Rehabil Nurs 2006;31:

222-224.3. Wuchty S, Jones BF, Uzzi B. The increasing dominance of teams in production of knowledge.

Science 2007;316:1036-1039.4. Cumbie S, Weinert C, Luparell S, et al. Developing a scholarship community. J Nurs Scholar

2005;37:289-293.5. de Meis L, Leta J. Modern science and the explosion of new knowledge. Biophys Chem

1997;68:243-253.6. Adair JG, Vohra N. The explosion of knowledge, references, and citations. Psychology’s unique

response to a crisis. Am Psychol 2003;58:15-23.7. Xyrichis A, Lowton K. What fosters or prevents interprofessional teamworking in primary and

community care? A literature review. Int J Nurs Stud 2008;45:140-153.8. Xyrichis A, Ream E. Teamwork: a concept analysis. J Adv Nurs 2008;61:232-241.9. Vance DE, Fazeli PL, Moneyham L, . Assessing and treating forgetfulness and cognitive problems

in adults with HIV. J Assoc Nurses AIDS Care 2013;24(1 Suppl):S40-60.10. Vance DE, Farr KF, Struzick T. Assessing the clinical value of cognitive appraisal in adults aging

with HIV. J Gerontol Nurs 2008;34:36-41.11. Vance DE. Troubles and triumphs of secondary data analyses: General guidelines. Research

Practitioner 2012;13:128-135.12. Vance DE. Improve scientific writing by decreasing the cognitive load placed on readers.

Research Practitioner 2013;14:40-50.13. Association AP. Publication manual of the American Psychological Association. 6th ed. Washing-

ton, D. C.: American Psychological Association; 2010.

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Continuing Education

Exam for Continuing EducationResearch Practitioner 15.33 Contact Hours

AMCs Show Renewed Interest in Industry Research: New Collaborations, Greater Trust Breaking Down Research Silos

1. Which of the following investigators conduct the largest proportion of clinical trials globally?A. Private-practice investigatorsB. University investigatorsC. Government investigatorsD. Investigator-initiated researchers

2. What percent of FDA-regulated clinical trials are conducted by community based investigators?A. 75%B. 64%C. 53%D. 47%

3. Academic medical centers’ increased interest in industry-sponsored trials is a result of innovative partnerships with industry that have built new levels of trust and collaboration between pharmaceutical companies and academia.A. TrueB. False

4. Why do experts predict academic medical centers will expand their involvement in industry-funded clinical trials in the future?A. Changing conflict of interest requirementsB. Tighter FDA regulationsC. Rising financial pressuresD. Increased informed consent requirements

5. Advantages of forming alliances with other AMCs include:A. a central IRB.B. it helps accelerate timelines.C. standardized SOPs.D. All of the above

6. One of the primary concerns about reporting requirements in the Sunshine Act is that they: A. may misrepresent the financial relationship between

investigators and industry.B. further confuse investigators already burdened by

federal regulation.C. further tax resources with the reporting requirements.D. burden investigators with reporting full payments.

7. The Sunshine Act was designed to increase the transpar-ency of the relationship between physicians — including clinical researchers — and drug and device manufacturers. A. TrueB. False

8. In its final rule, the Centers for Medicare and Medicaid Services (CMS) disagreed that reporting of research-related payment should be limited. What was NOT a reason listed?A. The inclusion of “research” as a nature of paymentB. The statutory definition of “clinical investigation” C. Congressional intent.D. The deadline for reporting requirements.

9. The process of determining fair market value for research should:A. be repeatable and consistent among studies.B. consider all investigator experience the same.C. consider similar research costs in the region.D. A and B onlyE. A and C only

10. AMCs can improve efficiencies in several ways, except:A. outsourcing patient recruitment.B. centralizing trial offices.C. reducing time for budget negotiations.D. developing master agreements with sponsors.

Requirements for Successful Completion

To receive contact hours, participants must register, read the full journal, then go to: http://thci.org/researchpracti-tioner/welcome.aspx. Follow the instructions on that page to register with your account number, select this issue, complete the evaluation, successfully complete the post-test with a minimum score of 70%, and view and print your certificate.


Solo vs Collaborative Scientific Writing Models: Balancing the Advantages and Disadvantages

11. The lead author is usually considered:A. the true author.B. the sole author.C. the senior author.D. the first author.

12. Process control refers to the ability to remain true to the article’s original vision an purpose and the ability to main-tain and coordinate tasks required to prepare an article for publication.A. TrueB. False

13. The last author listing on a journal title actually may be the:A. lead editor.B. primary contributor.C. lead researcher.D. sponsor representative.

14. Inviting coauthors onto an article one is developing is ad-vantageous for the production of the article because:A. the entire workload involved in writing the article does

not fall upon the first author.B. incorporating different writing styles from the

coauthors spices up the readability of the article. C. this allows the article to focus in several different areas

and tangents that may be more interesting for the reader.

D. this allows people to get know each other better.

15. Before writing an article with others, it is not necessary to determine what referencing format to use.A. TrueB. False

16. Outlines are useful for all of the following except:A. presenting ideas to others as to what the article will

focus to see if they are interested in participating as a co-author.

B. dividing up sections of the article according to the co-authors’ interests and expertise.

C. preventing drift from the original focus of the article.D. determining authorship order.

17. What does not indicate an intellectual contribution indicative of co-authorship?A. Writing the introduction of the articleB. Interpreting the data interpretation for the articleC. Conducting the statistical analyses for the articleD. Editing and fixing references for the article

18. Which of the following is not a legitimate reason to invite someone to serve as a coauthor on an article?A. Their skills and expertise are needed to contribute

important information to the article.B. It shows a history of publications in case you want to

apply for a grant together.C. They are a personal friend and you are trying to help

further their career.D. It is an excellent way to network professionally as you

garner their expertise for improving an article.

19. Cognitive load refers to:A. the amount of mental burden that interferes with goal-

directed tasks.B. the amount of theory of mind that interferes with goal-

directed tasks.C. the amount of acronyms that interferes with goal-

directed tasks.D. the amount of big (unfamiliar) words that interferes

with goal-directed tasks.

20. Acronyms should be used sparingly and judiciously because:A. they streamline the article.B. they introduce theory of mind.C. they can tax the cognitive resources of the author.D. they can tax the cognitive resources of the reader.


Regulatory Update

Q&A Guidance on the Meaning of ‘Spouse’ and ‘Family’

In the April 3, 2014, Federal Register, the FDA announced the availability of a guidance document titled The Meaning of “Spouse” and “Family” in FDA’s Regulations after the Supreme Court’s Ruling in United States v. Windsor — Questions and Answers: Guidance for Industry, Consumers, and FDA Staff. This guidance document informs the public of FDA’s interpretation of the effects of the Supreme Court’s decision in United States (US) v. Windsor on several of its regula-tions. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate.

On June 26, 2013, the U.S. Supreme Court struck down as unconstitutional part of the Defense of Marriage Act. In the guidance document, FDA sets forth how it now will interpret the terms “spouse” and “family” in FDA regulations. This guidance is being implemented without prior public com-ment because FDA determined that prior public participa-tion is not feasible or appropriate. Although this guidance document is immediately in effect, it remains subject to com-ment in accordance with FDA’s Good Guidance Practices regulation.

This guidance indicates that consistent with Department of Health and Human Service policy, FDA will interpret the terms “spouse” and “family” in its regulations to include same-sex spouses. The interpretation applies to any individu-als of the same sex who are lawfully married and whose mar-riage is valid in the state, territory, or foreign nation where it took place. Residence in a state that recognizes same-sex marriage is not required for the definitions to apply. The six parts of FDA regulations are affected by the Windsor deci-sion are:

■■ Freedom of Information Act (FOIA) program [21 CFR 20.44 (b)]. A “family member,” including a same-sex spouse, of an individual subject to an imminent threat may request expedited processing of a FOIA request.

■■ Human Subject Protection [21 CFR 50.3 (l), (m), 50.24(a)(6), (a)(7)(v), (b)]. “Family member” means, among other things, “spouse,” “brothers, sisters, and spouses of brothers and sisters,” and “any individual

related by . . . affinity whose close association with the subject is the equivalent of a family relationship.” An exception from the requirement to obtain informed consent of research subjects exists if obtaining informed consent is not feasible and a legally authorized representa-tive is not reasonably available. If feasible, an investigator must attempt to contact a subject’s family member, which can include a same-sex spouse, to ask whether he or she objects to the subject’s participation in the clinical inves-tigation. Additionally, if a subject remains incapacitated and a subject’s legally authorized representative is not reasonably available, an Institutional Review Board (IRB) shall ensure that there is a procedure to inform a family member, which can include a same-sex spouse, that he or she may discontinue the subject’s participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If such a family member is told about the clinical investigation and the subject’s condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member, which can include a same-sex spouse, can be contacted, information about the clinical investigation is to be provided to the subject’s legally authorized representative or such family member, if feasible.

■■ Financial Disclosure by Clinical Investigators [21 CFR 54.2(d)]. Part 54 of FDA’s regulations requires disclosure of certain financial interests and arrangements involving a “clinical investigator” and defines “clinical investigator” to include the investigator’s “spouse.” FDA now interprets Part 54 to require disclosure of certain financial interests and arrangements involving any clinical investigator’s same-sex spouse.

■■ IRB for FDA-regulated Research [21 CFR 56.107(d)]. Each IRB must have at least one member who is not otherwise affiliated with the institution and is not part of the “immediate family,” now including a same-sex spouse, of a person affiliated with the institution.

■■ Qualified Expert Panels for Indexing New Animal Drugs.,

■■ Mammography Quality Standards Program.

Interested persons may submit either electronic or written comments on FDA guidance documents at any time. Submit electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with Docket No. FDA-2014-D-0261.


Final Guidance on INDs for Placental/Cord Blood Transplants

In the March 5, 2014, Federal Register, FDA announced the availability of a final guidance document titled Guid-ance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System, dated March 2014.

The guidance document provides advice to potential spon-sors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an investigational new drug appli-cation (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hema-topoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alterna-tive treatment available. Unlicensed HPC, Cord Blood units made available for clinical use must be distributed under an IND.

The guidance announced in this document makes final the draft guidance of the same title dated June 2013 and supersedes the final guidance titled Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitu-tion for Specified Indications dated June 2011. FDA received no comments on the 2013 draft guidance and only editorial changes were made to improve clarity. Submit comments as instructed above. Identify comments with Docket No. FDA-2009-D-0490.

Q&A Draft Guidance for Humanitarian Device Exemption Holders In the March 18, 2014, Federal Register, FDA announced the availability of a draft guidance titled Humanitarian Device Exemption (HDE): Questions and Answers. This draft guid-ance answers commonly asked questions about humanitari-an use devices (HUDs) and HDE applications under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document reflects changes to

the HDE program as a result of the 2012 FDA Safety and Innovation Act (FDASIA).

Once this draft document is issued as a final guidance document, it will replace the existing HDE guidance titled Guidance for Humanitarian Device Exemption Holders, Insti-tutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff — Humanitarian Device Exemp-tion Regulation: Questions and Answers, which was issued prior to the enactment of FDASIA.

HUDs approved under an HDE cannot be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i.e., profit), except in certain circumstances. FDASIA expands the types of HDE-approved HUDs that are eligible to be sold for profit, subject to FD&C Act restrictions. FDASIA also amends the definition of the annual distribution number (ADN). If FDA determines that a HUD meets certain conditions, the HUD is permitted to be sold for profit after receiving HDE approval as long as the number of devices distributed in any calendar year does not exceed the ADN that FDA has determined.

Although interested persons can comment on any guidance at any time, to ensure that FDA considers your comments on this draft guidance before it begins work on the final version, submit either electronic or written comments on the draft guidance by June 16, 2014. Submit comments as instructed above. Identify comments with Docket No. FDA-2014-D-0223.

Draft Guidance on Developing Drugs for CFS/MEIn the March 11, 2014, Federal Register, FDA announced the availability of a draft guidance for industry titled Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment. The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encepha-lomyelitis (CFS/ME). The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of CFS/ME.

Currently, there are no approved therapies indicated to treat CFS/ME. The lack of approved therapies represents a public health concern. To foster drug development in CFS/ME, this draft guidance outlines the following key issues in drug development in CFS/ME:

■■ The case definitions or criteria for CFS/ME that could be used to define a patient population in the context of drug development,


■■ Recommendations for establishing efficacy in CFS/ME based on patient-reported symptoms and measurements of exercise capacity,

■■ Recommended trial design and duration, and

■■ Recommendations for establishing safety in CFS/ME.

Submit comments as instructed above. Identify comments with Docket No. FDA-2014-D-0264.

Draft Guidance on Developing Antiviral DrugsIn the February 28, 2014, Federal Register, FDA announced the availability of a draft guidance for industry titled At-tachment to Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data. The purpose of this guidance document is to assist sponsors in submitting human immunodeficiency virus (HIV) clinical virology data that are important for supporting clinical trials of products in development for the treatment of HIV.

HIV resistance data submitted in appropriately formatted da-tasets are critical components in the review of investigational antiviral products for the treatment of HIV. The information in this guidance will facilitate the development of anti-HIV products. This draft guidance revises the June 2006 guid-ance for industry titled Attachment to Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data. The revised guidance provides the format, recom-mended definitions, standardization of column headings and variables, and recommended data for submitting HIV resistance datasets. Submit comments as instructed above. Identify comments with Docket No. FDA-2014-D-0180.

Draft Guidance on Expedited Access to Medical DevicesIn the April 23, 2014, Federal Register, FDA announced the availability of a draft guidance titled Expedited Access for Pre-market Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions. This draft guidance outlines FDA’s proposal for a new, voluntary program for certain medical devices that dem-onstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA).

FDA believes that the Expedited Access PMA (EAP)

program will help patients have more timely access to these medical devices by expediting their development, assess-ment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premar-ket approval, consistent with the FDA’s mission to protect and promote public health. The guidance document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework.

FDA’s proposed EAP program contains features from the Center for Devices and Radiological Health’s Innova-tion Pathway, piloted in 2011 to facilitate the development and expedite the review of breakthrough technologies. In addition, the proposed EAP program is based in part on FDA’s experience with the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research programs that are intended to facilitate and expedite develop-ment and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening condi-tions (“FDA drug expedited programs”). However, while the EAP program incorporates some features of the FDA drug expedited programs, it is a separate and distinct program tai-lored to devices and intended to further speed the availabil-ity of certain safe and effective devices that address unmet public health needs.

As part of the EAP program, FDA intends to provide more interactive communications during device development and more interactive review of Investigational Device Exemption applications and PMA applications. This includes working with the sponsor to create a data development plan specific to the device, which would outline all data the sponsor intends to collect in support of device approval, and identify-ing what data would be collected premarket and postmarket. In addition, FDA intends to work interactively with the sponsor within the benefit-risk framework discussed in the FDA guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novo Classifications, issued on March 28, 2012, and in accordance with statutory and regulatory requirements, to determine whether certain data may be collected postmarket rather than premarket.

This guidance details the EAP process that will only be used at the request of the sponsor and with FDA’s agreement. In the same issue of the Federal Register, FDA announced another draft guidance titled Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, which also addresses the role of postmarket data and the benefit-risk framework to support premarket ap-proval, while still meeting the statutory standard of reason-able assurance of safety and effectiveness. Submit comments as instructed above. Identify comments with Docket No. FDA-2014-D-0363.


Draft Guidance on Balancing Premarket and Postmarket Data Collection

In the April 23, 2014, Federal Register, FDA announced the availability of a draft guidance titled Balancing Pre-market and Postmarket Data Collection for Devices Subject to Premarket Approval. This draft guidance clarifies FDA’s current policy on balancing premarket and postmarket data collection during FDA’s review of PMAs. Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guid-ance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process.

FDA has long applied postmarket controls as a way to reduce premarket data collection, where appropriate, while ensuring that the statutory standard for approval of reasonable assur-ance of safety and effectiveness is still met. The right balance of premarket and postmarket data collection facilitates timely

patient access to important new technology without under-mining patient safety.

In this draft guidance, FDA describes existing statutory requirements under the FD&C Act, its implementing regula-tions, and FDA policies that support the policy on balancing premarket and postmarket data collection during review of PMA applications. In addition, FDA clarifies how it consid-ers postmarket data as part of the benefit-risk framework described in FDA’s guidance Factors to Consider When Mak-ing Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, issued on March 28, 2012.

This guidance provides a resource for industry and FDA staff on how FDA determines when it is appropriate for a sponsor of a PMA to collect some data (clinical or non-clinical) in the postmarket setting, rather than premarket. It accompa-nies the FDA draft guidance document described above.

Although interested parties can comment on any guidance at any time, to ensure that FDA considers comments on this draft before it begins work on the final version, submit either electronic or written comments on the draft guidance by July 22, 2014. Submit comments as instructed above. Identify comments with Docket No. FDA-2014-D-0090.

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