2017 media guide

Connecting the Clinical Trials Industy

2018MEDIAGUIDE

2018 Media Guide 2

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C WWeekly is a dynamic responsive website committed to bringing readers quality, informative clinical research news and analysis on the issues and topics that affect this fast-paced, ever-changing industry. With continuous coverage of top stories,

business and financial news worldwide, original CenterWatch news, trends and data analysis, CWWeekly is the central source for comprehensive news and data for professionals spanning all sectors of the clinical trials industry.

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Patient centricity (continued from page 1)

CWWeekly September 18, 2017 5 of 11

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“There is untapped potential for new mobile technologies to support, engage and collect data from patients in clinical trials,” Lee told Cen-terWatch. “Regulatory acceptance of their use and viability grows each year as tech vendors, pharma and task forces like TransCelerate and ISPOR develop a stronger body of evidence for their place in clinical research.”

According to Lee, mProve is well-positioned to support the demand for mobile solutions and will continue to innovate their products by inte-grating with patient technology vendors such as Greenphire. He also said that the company’s mPal mobile platform has become the patient engagement solution choice for 18 of the top 20 pharmaceutical companies.

“Making real-time trial payment informa-tion available in the app is a natural product extension,” said Lee. He believes Greenphire is an ideal partner in part based on extensive use of ClinCard as a patient payment solution. “We value Greenphire’s long standing commitment to deliv-ering a high-quality participant experience, and we look forward to seeing the positive impact our partnership will have on our customers.”

Murphy cited three reasons why the clinical trial sector needs such a partnership. }} Patient retention: It will allow participants to

be paid quickly in a method they prefer.}} Reduced manual effort: Some 75% of sites

report spending more than 15 minutes per patient processing payments and reimburse-ments.}} Financial visibility and control: By centralizing

the participant payment process, transaction information is aggregated. As a result, stake-holders gain visibility, and manual efforts and

rework are reduced. Also, informa-tion is easily exported for financial reporting and planning.

Both Murphy and Lee said that improving patient centricity—and patient satisfaction—is important in successful clinical trials.

Lee stressed that patients need and want to be partners in their clinical research—a concept driving the patient-centricity movement. Offering patients access to all study services, information, reminders, etc., in a single app helps make par-ticipating in a clinical research trial a better experience.

According to a recent study by SCORR Marketing and Applied Clinical Trials, the use of mobile devices in clinical trials is still in its early stages. However, patient engage-ment was cited by 54% of the global service providers included in the survey, the third leading reason cited for adoption of mobile technology. Improved data quality (61%) and improved patient adherence (58%) were also mentioned most often.

“Keeping participants engaged in a trial is critical to the advancement of [any] study—without participants, life science research would not exist,” said Murphy. “Any and all efforts that put the participant at the center of the focus of the study should be paramount in the advance-ment of medicine. If patients aren’t having a pleasant experience, they will drop out and the study will suffer.”

In a release announcing the partnership, Gretchen Goller, global head of Patient Recruit-

ment at Icon, said her company has first-hand experience using both solutions in pivotal clinical trials.

“Both mProve Health’s mobile engage-ment solution and Greenphire’s ClinCard have proven to be valuable assets for Icon’s clients,” said Goller. “Combining these two solutions into one patient touch point aligns perfectly with our model for delivering patient-centric services to our sponsors.”

Patient use of mobile devices is a rising force in clinical trials. The SCORR survey found that 50% of those surveyed are already using such devices and 60% consider it to be very or extremely important.

“Patients are the lifeblood of clinical trials,” said Lee. “However, it’s no longer ac-ceptable to enroll patients, require a myriad of study visits, tests and procedures and take their data without providing value back.”

Hassman Research Institute (HRI), is pleased to announce that Dr. Larry Ereshefsky has joined the Company as Chief Scientific Officer, Early Phase Development. Dr. Ereshefsky brings to HRI more than 40 years of drug discovery and development experience including leadership roles at University of Texas Health Science and PAREXEL. Dr. Ereshefsky will be responsible for leading HRI’s efforts and advancing the Company’s Early Phase Development Division focusing on diseases. He will report to Dr. Howard Hassman, CSO of HRI.

About Hassman Research InstituteHRI has roots that run three generations deep and extend over five decades. Founded with the vision of “Improving the Quality of Life” for the patients we serve, our privately owned medical complex is located just twenty minutes from Philadelphia in Berlin, NJ. HRI conducts a full complement of inpatient and outpatient Phase I-IV research trials specializing in Psychiatry, Addiction, Pain Management, Human Abuse Liability, Hepatic/Renal, and Internal Medicine.

Source: mProve Health

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throughout the clinical research enterprise. WISC will map how competencies in the eight core domains outlined by the JTF ap-ply to the study coordinator role at different levels. The committee plans to publish a first draft of its CRC competency framework by early next year. As organizations begin to test and implement the standards, and as technologies and processes change, the competencies are expected to continue evolving.

Membership of the WISC includes repre-sentation from a broad group of private and public stakeholders, including the Association of Clinical Research Organizations (ACRO), Amgen, Bioclinica, Greater Gift Initiative, Medix, Medtronic, NIH, Pfizer, PPD, Roche and the U.S. Department of Veterans Affairs Office of Research and Development.

Recognition of the need to advance the professionalization of the clinical trial work-force has grown in recent years as the indus-try faces difficulties filling clinical research jobs and as many in the workforce express frustration with the lack of career advance-ment opportunities. In addition, a recent study conducted by a recruitment agency for the clinical research industry reported that a review of CRA resumes in its database showed 17% contained false information.

Other organizations have taken steps

to standardized clinical research workforce competencies in recent years. INC Research, which has merged with inVentiv Health, for example, developed a competency-based training program for entry-level CRAs that integrated training and the development of skills. George Washington University, where Harper is an adjunct professor, recently revamped its curriculum to align with the JTF competency framework. In another example, PPD began a CRA training program for veterans based on competency standards, which was designed to bypass standard work experience requirements.

In one of the most far-reaching initia-tives, the Duke University School of Medicine built competency-based job descriptions for research professionals institution wide and adapted JTF core com-petencies into its assessments and training opportunities. Revising its job classifica-tions—consolidating the number from 80 different classifications to 12—and building a three-tiered ladder into core classifica-tions, allowed Duke to standardize roles and encourage professional development.

“We went about the job classification with competencies because, in my mind, that is where the industry of clinical research is going. Whether you are an academic

medical center or industry, we have to get to competency-based training. We have to get to a place where people can show us they are competent in their role and it’s a good fit for them. We have to stop flying by the seat of our pants and saying, ‘Hopefully this person will work out.’ We need to put some concrete things in place that actually demonstrate something is true, or not true, in terms of job performance,” said Denise Snyder, associate dean for clinical research, Office of Clinical Research, Duke University School of Medicine. “It builds more fairness and expectations into what the job really is and what they need to be able to do.”

Going forward, Harper said the industry needs to be proactive in defining compe-tencies and adopting standards before the government creates mandates or licensure requirements for clinical research profes-sionals.

“We want to say, as an industry, we believe in the need for standards, they will enhance the quality of the workforce and translate into improved quality in the conduct of clinical trials,” said Harper. “If we don’t have adequately trained and compe-tent people, the quality issues will prevail, no matter how much technology we have.”

CWWeekly October 16, 2017 2 of 2

Special article reprint

CWWeekly (ISSN 1528-5731). Volume 21, Issue 41. © 2017 CenterWatch centerwatch.com

The Association of Clinical Research Professionals (ACRP) has launched a new initiative to develop competency

standards for clinical research coordinators (CRCs) as part of a larger effort to advance the professionalism of the clinical research workforce.

The project will establish minimum standards regarding the knowledge and skill required for entry-level study coordinators and create a hierarchy of competencies fo-cused on performance rather than longevity. Pathways needed for CRCs to advance their careers will be clearly defined and ACRP will develop tools to assess job proficiency, identify gaps and provide training.

Beth Harper, ACRP workforce innovation officer, said since the industry lacks standard competency-based job descriptions and train-ing requirements or assessments for study co-ordinators, the quality of the workforce varies greatly. An experienced nurse might become a study coordinator at a site or, alternatively, the office receptionist might inherit the role. For ACRP, the fact that the most common FDA inspection findings, which include protocol de-viations and informed consent issues, haven’t changed for several years at investigative sites indicates a need for clearly defined and enforced core competencies.

“We have people coming into the role at a site without any standard definitions. The result is quality issues and, potentially, patient safety issues,” Harper said.

Implementing competency-based job descriptions could allow unexperienced study coordinators to enter the workforce by demonstrating knowledge through the completion of training courses, which could help boost the availability of a qualified talent pool, and would bolster opportuni-ties for professional advancement. Histori-cally, the industry has prioritized a two-year experience requirement over validated competency for CRCs and a recent study in the Journal of Law, Medicine & Ethics found that most open CRC positions take an aver-age of three to six months to fill. Another report published in Clinical and Translational Science Journal found 41% of CRCs said they don’t feel they have an opportunity for

career advancement or development, which contributes to high turnover rates.

“We want to help people see that if you focus on your competencies and understand where your competence gaps are, regardless of your experience, you may be able to ac-celerate to a higher level much more quickly by demonstrating that you are competent,” said Harper. “People could see there is an opportunity to make a career and not just leave because they were disappointed or had a bad experience.”

The announcement of the CRC initia-tive is part of the ACRP’s aim of leading the standardization of the clinical trial workforce and to support its ongoing development through competency-based education and training. In April, the organization intro-duced its Core Competency Framework for Clinical Study Monitors.

“We look forward to this initiative having a lasting impact on the quality and profes-sionalism of the clinical research workforce,” said Jim Kremidas, executive director of ACRP. “We hope to collaboratively equip industry with standardized measures of competence that will help reduce variance in workflow competence and assist in growing the clinical research workforce of tomorrow.”

The new CRC initiative, which will be driven by the ACRP Workforce Innovation Steering Committee (WISC), will build on a set of high-level standards established by the Joint Task Force (JTF) for Clinical Trial Competency, which were developed by a multi-stakeholder group to serve as a frame-work for defining professional competency

A CenterWatch Publication

Special Article Reprint • October 16, 2017

CWWeekly (ISSN 1528-5731). Volume 21, Issue 41. © 2017 CenterWatch centerwatch.com

ACRP advances CRC competency-based standards By Karyn Korieth

“We have people coming into the role at a site without any standard

definitions. The result is quality issues and potentially patient safety issues. ”

—Beth Harper, ACRP workforce innovation officer

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TECHNOLOGY IS REVOLUTIONIZING THE CLINICAL RESEARCH LANDSCAPE

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overall clinical strategy and promote col-laboration between functions early in the clinical development program.

“Clinical supply and clinical operations should be strategically aligned in an efficient way with clear roles and responsibilities, and use integrated technology to manage study supply and data collection. Clinical supply is a unique function and can be sitting in many different places depending on each company’s structures and business. But no matter where they sit, the most important thing is to connect clinical operations and clinical supply,” said Richard Hsia, senior director, Clinical Trial Management, Sunovion Pharmaceuticals. “I advocate for a more proactive approach and applying advanced technology that allows for more information sharing and an emphasis on enhanced communication that is more ef-ficient with better control for study quality.”

More flexible just-in-time labeling and demand-led supply models have emerged that can minimize the impact of changes in clinical supply strategy or forecasting dur-ing a clinical trial. Inventory can be stored in regional depots, which limits loss at indi-vidual sites, and distributed to sites quickly when needed. These late-stage customiza-tion models also allow for sharing of one product or package type across multiple sites, countries and studies.

“The clinical supply chain has tradition-ally used a ‘push’ model. We try to antici-pate where these patients are going to be and we ‘push’ material to facilities or depots or clinical sites around the world, which is very wasteful if the sites or country don’t recruit. For the first time, we are now starting to see more of a ‘pull’ model and we are using technology to drive packaging and distribu-tion of clinical materials based on demand, which is a fast, flexible approach with poten-tial for better management of drug use,” said Christine Milligan, Ph.D., global director of Strategic Development Solutions at Catalent Pharma Solutions.

New supply chain technologies and mod-els are being developed to support direct-to-patient models, which were once viewed as

unrealistic due to quality and cost concerns. In one example, AmerisourceBergen has de-veloped a small medical-grade refrigerator, called CubixxCT, which allows tempera-ture-sensitive investigational products to be stored in a patient’s home or office, eliminat-ing the need for frequent deliveries. The unit also provides remote temperature monitor-ing, inventory management and access con-trol.

“People have known about direct-to-pa-tient trials for a while and want to explore them. But the supply chain element has al-ways been the challenge in making sure the quality is there,” said Sam Herbert, president of World Courier, an arm of Amerisource-Bergen that specializes in global logistics

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Impact of kit design on adherenceDid the design/layout of the medicine kit help you take your medicine on schedule?

Overalln=1,425

Bottlen=596

BlisterPack

n=426

Syringen=212

Topicaln=116

Inhalern=110

Othern=132

Yes 60% 54% 75% 50% 71% 62% 46%

No 30% 36% 21% 34% 21% 28% 30%

Don’t remember 11% 10% 5% 16% 9% 10% 23%

Source: 2012 ISPE–CISCRP Study, n=1,425 study volunteers

see Supply chain management on page 18

© 2017 CenterWatch. Duplication or sharing of this publication is strictly prohibited. | The CenterWatch Monthly June 2017 17

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are waiting for evidence new drug appli-cations that used RBM approaches will pass regulatory scrutiny. In addition, the industry has yet to determine which met-rics should be used to measure the success of RBM approaches. Some companies that have been working on their RBM initia-tives for a few years have collected evidence to validate their model, from both a quality and cost reduction standpoint, and Tran-sCelerate has conducted surveys on core quantitative performance metrics among its members that show generally positive results. Company-specific metrics, how-ever, have not been widely published or shared in the industry.

Technology challenges have also af-fected the adoption of risk management and RBM strategies. Comprehensive, inte-grated data from multiple sources is need-ed to facilitate RBM. Yet systems are not typically integrated and most clinical trial technologies, such as EDC, lack the capa-bilities needed to tag and run analytics around critical data. Early RBM adopters usually built data aggregation and analyt-ics in-house to support risk-based process-es and ensure timely access to integrated data. While technology companies have begun to develop capabilities to integrate data from different sources for RBM and apply sophisticated algorithms to detect risk, the technology solutions tend to lag behind company needs and are expensive to implement. The 2017 Avoca Group sur-vey found that only 34% of sponsors were satisfied with the level of innovation and technology in the areas of RBM and risk-based quality management.

“Technology providers in RBM are de-veloping parts and pieces,” said PPD’s Stansbury. “Not all of the systems connect, even within a single technology provider, and user interfaces may not align with CRO roles and process, reducing efficien-cies and delivery according to the CRO strategy and process. In addition, there are costs to obtain multiple separate pieces

and link components across different tech-nology vendors and CRO systems.”

Sponsors and CROs also need to de-velop RBM and centralized monitoring processes that don’t transfer risk and ad-ministrative burden to investigative sites. During the transition to remote monitor-ing, some organizations lacked access to needed information and asked sites to scan or fax documents to off-site locations. As these models evolve, an effective program shouldn’t add burden to investigative sites. But sites most likely will need to interact with both a central monitor and a clinical research associate (CRA), which some in-vestigators worry could result in duplica-tion of effort, and sponsors and CROs need to consider how the role of CRAs and their relationships with sites will change.

“Ideally, the RBM model should not re-quire any additional work at the site lev-el,” said Parexel’s Flinois. “However, we know from site and investigator feedback that many have experienced a decrease in support and guidance from CRAs in tri-als where RBM was employed. Early RBM studies decreased SDV and extended visit schedules without making compensatory adjustments to ensure that new practices were completed with training and sup-port provided by the CRA in a cohesive environment regardless of whether inter-actions occur on-site or off. In next gen-

eration RBM studies, sites should be given this type of support and receive feedback from the CRO or sponsor project team about possible emerging risks as well as po-tential solutions based on signals surfaced through RBM technological solutions.”

New approaches required

Companies will need to address chal-lenges and implement a system to manage quality throughout the lifecycle of a trial using risk-based approaches to comply with the revised ICH E6 R2 guidelines. Importantly, the new guideline recognizes that not all risks are of equal importance from a compliance and quality perspective and that companies can increase the over-all quality of their data and provide better oversight of patient safety by defining and focusing attention on critical processes and data.

“The new guidelines consolidate the thinking that we have seen from multiple regulatory agencies around implementa-tion of quality management processes and applying risk-based approaches to trial execution,” said Lilly’s Gough. “What this guideline clarifies is the need for processes to set clearly defined, data-based, quantita-tive thresholds to the identified risks and also the continuous learning cycles that will inform how those thresholds are set

The CenterWatch Monthly (ISSN 1556-3367). | October 2017 | © 2017 CenterWatch centerwatch.com 4 Feature Article Reprint

Expectations on the number of studies involving risk-based monitoring Compared to 2015, do you expect the number of studies that will require RBM at your investigative site 2016 to ...

Source: CenterWatch ACRP survey 2016; n=200, excludes ‘I don’t know’

1%Decrease

41%Remain the

same 58%Increase

Among those expecting an increase in the number of studies requiring RBM from 2015 to 2016, an average

increase of 33% in the number of studies requiring RBM is expected.

The CenterWatch Monthly (ISSN 1556-3367). Volume 24, Issue 10. © 2017 CenterWatch centerwatch.com

Growing utilization but wide variation in approaches and impactBy Karyn Korieth

F or all the talk about how risk-based monitoring (RBM) can improve ef-ficiencies in clinical trial processes,

the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodol-ogy and some organizations have not yet pursued alternatives to traditional moni-toring strategies.

Most sponsor companies have indi-cated they intend to move away from the long-established monitoring approach that relies on frequent on-site visits and 100% source data verification (SDV) to en-sure patient safety and data quality. Yet in practice, the challenges of implementing a targeted or risk-based monitoring strategy have proven to be harder than anticipated.

A new Metrics Champion Consortium (MCC) survey reported a 37% increase in use of RBM supported by centralized data analytics across programs or on a pilot ba-sis from 2013 to 2015. Yet only half of re-spondents used RBM in pivotal trials and a majority (62%) continue to use traditional 100% SDV. RBM programs at many spon-sor companies have not advanced beyond the pilot phase or have been introduced across the organization without standard-ized processes or established success mea-

sures. In a 2017 survey of more than 300 clinical research leaders about risk, the Avoca Group found that about a third of sponsor respondents acknowledged a lack of good understanding about best practic-es for risk-based approaches.

Moving forward, however, more studies are expected to use RBM methodologies as companies are required to incorporate the revised International Conference on Har-monization (ICH) Good Clinical Practice (GCP) E6 R2 guidelines into their pro-cesses and practices. The new guidelines, which were finalized in November 2016, expect companies to implement a risk-based approach to quality management and clinical trial execution that includes monitoring practices. The regulatory doc-ument also supports the use of RBM and centralized monitoring processes. To show compliance with the revised guidance, companies will be asked to document and defend the rationale for the chosen moni-toring strategy.

Kristin Mauri, global head of Risk-Based Monitoring at Bioclinica, said many com-panies have struggled, however, to under-stand the new regulations or have failed to acknowledge that current practices don’t fully comply with ICH E6 R2. Due to the

extent and significance of the changes re-quired, companies that have not begun to assess the impact of the revised guidelines on their organizations are at risk of falling behind. Mauri believes it may take a large company having a widely publicized in-spection failure to drive more rapid adop-tion of risk-based approaches that are com-pliant with the new regulations.

“Many of us in the industry expected a much faster adoption curve than we have seen,” said Mauri. “Many companies are now just starting to do an impact analysis on the revised guidelines and are looking to change their approach. It’s happening, but it’s slow. I expect that as we move into 2018, the number of RBM studies will in-crease significantly.”

Adoption rates slowly rising

The Clinical Trials Transformation Ini-tiative (CTTI), a public-private partner-ship formed in 2009 by the FDA and Duke University to drive adoption of quality by design (QbD) principles in clinical trials, made promoting RBM as part of a broader overall quality framework a key initiative and helped increase industry awareness around the approach. CTTI raised con-

Tracking adoption of risk assessment and RBM October 2017 A CenterWatch Feature Article Reprint Volume 24, Issue 10

Tracking the adoption of RBMPercentage of companies reporting use of risk-based monitoring approaches

Source: Metrics Champion Consortium 2016

27%

52%

75%

31

201520132011


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2018 Media Guide 9

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2018 Media Guide 10

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CWWEEKLY RESPONSIVE ADVERTISING PRICING, SPECS AND TECH

2018 Media Guide 16


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