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Volume 23, Issue 05. © 2019 CenterWatch. All rights reserved. Join the CenterWatch Community! see Staff Training on page 3 » see Speed Trials on page 4 » ICH GCP E6 R2 MEETING CRO-VENDOR OVERSIGHT REQUIREMENTS WEDNESDAY–THURSDAY MARCH 27–28, 2019 RALEIGH, NC REGISTER NOW An Interactive Workshop Presented by CenterWatch and Wool Consulting Group February 4, 2019 Industry Briefs…2 Drug & Device Pipeline News…6 Thirteen drugs and devices have entered a new trial phase this week. JobWatch…7 Job listings, networking events and educational programs. CenterWatch Weekly By Bill Myers A Michigan CRO is teaming with MIT’s Computer Science and Artificial Intelligence Laboratory and the University of Maryland’s Center for Tran- sitional Medicine (CTM) to create what organizers are calling “a supergroup” that will help speed drugs through the clinical trials pipeline. Officials at MMS Holdings of Canton, Mich., MIT and Maryland’s CTM call their new venture the Health Analytics Collective. Its goal is to help use data — particularly real-world data — to help cut down on the time spent in trials, to augment label claims and to support new drug applications. The group wants to merge real-world evidence and observational evidence from routine clinical practices with patient health- care databases. The venture will rely on MIT’s Julia programming language, which is designed to whip through complicated computational problems quickly. Julia, organizers hope, will help the group sift through massive amounts of data quickly to help compare effectiveness claims of a given drug against similar compounds, to help put together efficacy or safety data on a drug or device, to assess treatments already on the market, to sniff out treat- ment gaps and to help evaluate patient risk quickly. It’s all to, as organizers say, “guide a company’s business decisions with insights into a potential asset’s life-cycle manage- ment and due-diligence efforts.” New Collaboration Aims to Use Advanced Data Analysis to Speed Trials By Bill Myers G aps and gray areas in federal train- ing requirements wind up putting pressure on principal investigators when the burden rightly belongs on spon- sors’ shoulders. But in practice, says Jan S. Peterson, vice president of regulatory affairs and quality for Global Regulatory Partners, investigators may find themselves taking on responsibil- ity for training the rest of the staff. In the face of minimal guidance from the FDA or ICH, “the sponsor should be driving this training/training documentation issue using clear, written requirements,” Peter- son says. Investigators and sites should be prepared to walk away if they don’t get suf- ficient guidance and time to train properly. FDA regulations say only that sponsors must hire investigators “qualified by training and experience.” The ICH E6 GCP guideline says investigators must ensure that all trial staff are “informed about their obligations.” “If the PI feels there’s inadequate train- ing,” says Dalfoni Banerjee, CEO of 3Sixty Pharma Solutions, “that could mean there are systemic problems in the trial. A lot of systemic problems begin with a simple one: less than effective communication.” Banerjee says sponsors can open up — and sustain — lines of communication by beginning a trial with a survey of the PIs. Questions such as, “What are your expecta- tions for this trial?” or “What tools do you need for a successful trial?” can bring back Sites and Sponsors Need to Collaborate on Staff Training Accelerate your CRA career and get instant answers to your toughest clinical research procedural questions ORDER TODAY The most complete guide to successful practices of high-performing CRAs. New edition for 2019! Elizabeth Weeks-Rowe The CRA’s Guide to Monitoring Clinical Research FIFTH EDITION ipelineNews FDA Actions Company name FDA action Lumendi, LLC second-generation endoscopic accessory indicated visualization, diagnosis and endoscopic treatment 510(k) clearance granted Varian 510(k) clearance granted Conavi TM Medical Inc. 510(k) clearance granted Prisyna, the oral care division of S510(k) clearance granted C4 Imaging LLC to accurately locate the position of the applicators that guide the placement of radioac tive sources for 510(k) clearance granted Amerigen Pharmaceuticals Limited and Dipharma SaNDA filed Sage Therapeutics NDA filed Veloxis Pharmaceuticals A/S Prophylaxis of organ rejection in kidney transplant sNDA filed Jazz Pharmaceuticals Abeona TherapeuticImmusofStealth Biotherapeutics Pfizer Inc. MeiraGTdefects in the retinitis pigmentosa GTPase regulator (RPGR) gene e following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including e FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/. r custom drug intelligence reports, email [email protected]. Join the LinkedIn Drug Research Updates group! Addressing Barriers to Entry and Retention B Industry Tries to Stem Investigator Dropout CRA/CRC Shortages Slow Clinical Trial Pace Industry Developing Standardized Training The CenterWatch Monthly provides in-depth and data-rich insights on key trends impacting the clinical resarch landscape. SUBSCRIBE TODAY » Valuable clinical study leads » Detailed drug intelligence » Key regulatory updates Increase your visibility to Sponsors and CROs Generate clinical study leads Social media outreach Build research site awareness POST A RESEARCH CENTER PROFILE Clinical Research of West Floriday, Inc. Therapeutic Areas Therapeutic Areas Clinical Research of West Floriday, Inc. Therapeutic Areas ch of West Customize your page with: Clinical trial listings for recruitment purposes List your medical specialties, performance metrics, etc.

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Page 1: Join the CenterWatch Community CenterWatch group wants to merge real-world evidence and observational evidence from routine clinical practices with patient health - care databases

Volume 23, Issue 05. © 2019 CenterWatch. All rights reserved.

Join the CenterWatch Community!

see Staff Training on page 3 »

see Speed Trials on page 4 »

ICH GCP E6 R2 MEETING CRO-VENDOR

OVERSIGHT REQUIREMENTSWEDNESDAY–THURSDAY

MARCH 27–28, 2019RALEIGH, NC

REG ISTE R NOW

An Interactive Workshop Presented byCenterWatch and Wool Consulting Group

February 4, 2019

Industry Briefs…2

Drug & Device Pipeline News…6Thirteen drugs and devices have entered a new trial phase this week.

JobWatch…7Job listings, networking events and educational programs.

CenterWatchWeekly

By Bill Myers

A Michigan CRO is teaming with MIT’s Computer Science and Artificial Intelligence Laboratory and the

University of Maryland’s Center for Tran-sitional Medicine (CTM) to create what organizers are calling “a supergroup” that will help speed drugs through the clinical trials pipeline.

Officials at MMS Holdings of Canton, Mich., MIT and Maryland’s CTM call their new venture the Health Analytics Collective. Its goal is to help use data — particularly real-world data — to help cut down on the time spent in trials, to augment label claims and to support new drug applications.

The group wants to merge real-world evidence and observational evidence from

routine clinical practices with patient health-care databases. The venture will rely on MIT’s Julia programming language, which is designed to whip through complicated computational problems quickly.

Julia, organizers hope, will help the group sift through massive amounts of data quickly to help compare effectiveness claims of a given drug against similar compounds, to help put together efficacy or safety data on a drug or device, to assess treatments already on the market, to sniff out treat-ment gaps and to help evaluate patient risk quickly. It’s all to, as organizers say, “guide a company’s business decisions with insights into a potential asset’s life-cycle manage-ment and due-diligence efforts.”

New Collaboration Aims to Use Advanced Data Analysis to Speed Trials

By Bill Myers

G aps and gray areas in federal train-ing requirements wind up putting pressure on principal investigators

when the burden rightly belongs on spon-sors’ shoulders.

But in practice, says Jan S. Peterson, vice president of regulatory affairs and quality for Global Regulatory Partners, investigators may find themselves taking on responsibil-ity for training the rest of the staff.

In the face of minimal guidance from the FDA or ICH, “the sponsor should be driving this training/training documentation issue using clear, written requirements,” Peter-son says. Investigators and sites should be prepared to walk away if they don’t get suf-ficient guidance and time to train properly.

FDA regulations say only that sponsors must hire investigators “qualified by training and experience.” The ICH E6 GCP guideline says investigators must ensure that all trial staff are “informed about their obligations.”

“If the PI feels there’s inadequate train-ing,” says Dalfoni Banerjee, CEO of 3Sixty Pharma Solutions, “that could mean there are systemic problems in the trial. A lot of systemic problems begin with a simple one: less than effective communication.”

Banerjee says sponsors can open up —and sustain — lines of communication by beginning a trial with a survey of the PIs. Questions such as, “What are your expecta-tions for this trial?” or “What tools do you need for a successful trial?” can bring back

Sites and Sponsors Need to Collaborate on Staff Training

Accelerate your CRA career and getinstant answers to your toughest

clinical research procedural questions

ORDER TODAY

The most complete guideto successful practices ofhigh-performing CRAs.

New edition for 2019!

Elizabeth Weeks-Rowe

The CRA’s Guide to Monitoring Clinical Research

FIFTH EDITION

PipelineNews

FDA Actions

Company name Drug name Indication FDA action

Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment

510(k) clearance granted

Varian Calypso Anchored Beacon transponder

tumor detection 510(k) clearance granted

Conavi TM Medical Inc. Novasight Hybrid System simultaneous imaging of coronary arteries with both intravascular ultrasound (VUS) and Optical Coherence Tomography (OCT)

510(k) clearance granted

Prisyna, the oral care division of Synedgen

Moisyn product line xerostomia 510(k) clearance granted

C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers

510(k) clearance granted

Amerigen Pharmaceuticals Limited and Dipharma S.A.

Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option

aNDA � led

Sage Therapeutics intravenous formulation of brexanolone (SAGE-547)

postpartum depression (PPD) NDA � led

Veloxis Pharmaceuticals A/S

de novo indication of ENVARSUS XR (tacrolimus extended-release tablets)

Prophylaxis of organ rejection in kidney transplant patients

sNDA � led

Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution

cataplexy and Excessive Daytime Sleepiness (EDS) in pediatric narcolepsy patients

sNDA � led

Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of San� lippo syndrome Type A (MPS IIIA)

RMAT Designation granted

Immusoft Corporation Immune System Programming MPS I (Mucopolysaccharidosis type I) Orphan Drug Designation granted

Stealth Biotherapeutics elamipretide Leber’s hereditary optic neuropathy (LHON) Orphan Drug Designation granted

P� zer Inc. TRUMENBA (Meningococcal Group B Vaccine)

Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years

Breakthrough Therapy Designation granted

MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene

Fast Track Designation granted

The following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including the FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/.For custom drug intelligence reports, email [email protected]. Join the LinkedIn Drug Research Updates group!

9:45 AMiPad3

Addressing Barriersto Entry and Retention

By Sony Salzman

B eing a principal investigator (PI) is tough. So tough, in fact, that more than half of new investigators give up er

thei rst FDA-regulated drug trial.Studies by the T s Center for the Study of

Drug Development (CSDD) have revealed a variety of challenges for rst-time investigators.

e rst — and some would say worst — challenge is that the path to success for PIs is murky, said Gerrit Hamre, project manager of CTTI and co-author of the group’s paper on the study. Although there are training programs and resources for investigators, most new investigators are unaware of their existence (outside of GCP training), and un-derestimate the infrastructure, st ng, bud-geting, contracting, and operational skills necessary to succeed.

e second overwhelming obstacle for edgling investigators is administra-

tive burden. Complex protocols, rigorous reporting demands and multiple technol-ogy platforms place a huge strain on inves-tigators and sta .

e third major obstacle new PIs face is the lack of accolades and/or s cient nancial reward to make all of that e ort worthwhile.

With mounting evidence that the prob-lem isn’t getting better, sponsors and CROs are rethinking the site selection process and trying to develop new ways to support inex-perienced investigators.

Sponsors and CROs are doubling-down on their top-performing sites — a trend that has helped fuel industry consolidation, says Ken Getz, director and associate professor of CSDD.

“At the same time that sponsors are look-ing for scaled, experienced sites and site networks, the CROs are buying them,” said Getz.

He predicts that in the short term, the in-dustry will continue to see the largest and most expensive sites and site networks build more share of the market.

Yet sponsors can’t rely solely on vetted academic medical centers and large com-mercial sites for all of their study partici-pants; the burgeoning elds of rare disease and oncology research in particular require them to cast a wider net for patients.

Experts agree that rst time investiga-tors can take some steps to bolster success — including nding a mentor, hiring an ex-perienced research coordinator, learning to budget appropriately and being technologi-cally savvy and platform-agnostic — but most also agree that ultimately, sponsors and CROs need to step up if they want their PIs to thrive.

“I’m sympathetic to investigators because you don’t know what you’re getting into,” says Hamre, adding, “I do think investiga-tors very en bite o more they can chew, but they don’t realize it. In that regard, I think it’s the sponsors and the CROs that have a bit more responsibility.”

Getz added that sponsors must “take ownership for site selection practices that

Industry Tries to Stem Investigator Dropout

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited.

CRA/CRC Shortages Slow Clinical Trial Pace

June 2018 A CenterWatch Publication Volume 25, Issue 06

see CRA/CRC on page 8

Industry DevelopingStandardized TrainingBy Daphne Butas

As clinical trials continue to change, the evolving roles of CRAs and CRCs are exacerbating the problems sponsors and

CRO nding well-trained candidates.“What’s going to really get interesting is how

much these roles are going to evolve as more new initiatives come forward, like eConsent,

ePRO and risk-based monitoring,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). As risk-based monitoring has taken hold and more monitors are analyzing data from a central loca-tion rather than traveling to the sites, sponsors and CROs are looking for CRCs with more of a robust math background, he said. And as the sponsors’ and CROs’ relationships with sites becomes ever more important, sponsors and CROs are looking for CRAs who excel at forg-ing friendly, supportive connections with sites.

“I think we’re going to see a morphing of these role into subspecialties — a data analyst and site-relationship manager type of CRA, along with the traditional role that the CRA has always had,” said Kremidas. “With CRCs, I think we’ll begin to see a quality assurance focus, someone who oversees the input of the data into the eCRFs. I think we’ll see a tech-nology type of specialist for patients to call in order to get help logging on. And I think the traditional role will be there, too.”

see Investigator Dropout on page 6

The CenterWatch Monthly provides in-depthand data-rich insights on key trends impactingthe clinical resarch landscape.

SUBSCRIBE TODAY

» Valuable clinical study leads» Detailed drug intelligence» Key regulatory updates

Increase your visibility to Sponsors and CROs

Generate clinical study leads

Social media outreach

Build research site awareness

POST A RESEARCH CENTER PROFILE

9:45 AMiPad3

Clinical Research of WestFloriday, Inc.

Therapeutic AreasTherapeutic Areas

Cardiology/Vascular DiseasesDermatologyDevicesEndocrinologyGastroenterologyHealthy VolunteersImmunologyInfections and Infectious DiseasesInternal MedicineMusculoskeletalNeurologyObstetrics/Gynecology (Women’s Health)OphthalmologyOrthopedics/Orthopedic SurgeryPharmacology/ToxicologyPsychiatry/PsychologyPulmonary/Respiratory DiseasesRheumatologyUrology

Aydin KeskinerPresidentClinical Research of West Florida, Inc.2147 NE Coachman RoadClearwater, FL 33765-2616USA727-466-0078727-461-7793 (fax)[email protected] Map

Contact Center

Currently Enrolling Trials

• Are you a current or former smoker? • Are you one of 5 million living with Lupus? • Crohn's Study • Cutaneous Lupus Study[Show More]

Clinical Research of WestFloriday, Inc.

Therapeutic AreasAydin KeskinerPresidentClinical Research of West Florida, Inc.2147 NE Coachman RoadClearwater, FL 33765-2616USA727-466-0078727-461-7793 (fax)[email protected] Map

Contact Center

Clinical Research of West

Customize your page with:• Clinical trial listings for recruitment purposes• List your medical specialties, performance metrics, etc.

Page 2: Join the CenterWatch Community CenterWatch group wants to merge real-world evidence and observational evidence from routine clinical practices with patient health - care databases

© 2019 CenterWatch. Duplication or sharing of this publication is strictly prohibited. CWW2305

WCG | CWWeekly (ISSN 1528-5731)

Leslie Ramsey Editorial DirectorBill Myers Clinical Trials SpecialistRenee Breau ProductionRussell Titsch Business Development Director

© 2019 CenterWatch. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher.

CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 [email protected] / [email protected]

Permission requests can be emailed to [email protected].

Advertising packages and reprints are available:Email [email protected] or call (703) 538-7651.

WCG | CWWeekly February 4, 2019 2 of 7

Industry Briefs

Genentech Pulls Plug on Two Alzheimer’s TrialsGenentech has closed two large Phase III trials for its once-hyped anti-Alzheimer’s drug cren-ezumab after an independent data monitoring committee warned the company that cren-ezumab wasn’t likely to hit its primary endpoint.

The CREAD 1 and CREAD 2 trials had enrolled 1,500 patients worldwide, all of them in the early stages of Alzheimer’s disease, and offered patients doses four times higher than in the Phase II trials that had showed promise in helping patients.

But Genentech, a subsidiary of Roche, an-nounced last week that its IDM committee told them the drug didn’t seem to be improving patients’ scores on individual cognitive tests.

Genentech officials acknowledged the “disappointing” results but said that they’re still studying crenezumab in an ongoing trial of clinically healthy patients in Colombia who carry the genetic mutation associated with heritable Alzheimer’s.

J&J Scores on Phase III Metastatic Prostate Cancer TrialJohnson & Johnson says it has scored another victory for its anti-cancer drug Erleada (apalu-tamide), this time in patients with metastatic prostate cancer.

The FDA approved Erleada for non-meta-static prostate cancer in February 2018. Last week, Johnson & Johnson subsidiary Janssen Pharmaceutical Companies announced that its Phase III TITAN trial of Erleada and a combina-tion of androgen-depravation therapy had met its two primary endpoints — radiographic, progression-free survival and overall survival.

The specific numbers weren’t released but Johnson officials promised to unveil them “at an upcoming medical congress.”

TITAN was a Phase III, randomized, placebo-controlled, double-blind study in men newly diagnosed with metastatic disease. More than 1,050 men were given either Erleada plus an-drogen depravation or a placebo with androgen depravation. The men were treated until the dis-

ease progressed, until they suffered from drug toxicity, or until they chose to stop treatments.

Erleada is an androgen receptor inhibitor and the first of its kind to win FDA approval for non-metastatic, castration-resistant prostate cancer.

Startup Launches Drug Development Program, Will Donate Rights to Nonprofit Clinical trial service provider Notable Labs is making its first foray into research with a new investigational leukemia drug and plans to sign over rights to the pediatric treatment to the nonprofit group Cures Within Reach.

Notable has developed its own compound, ND-1000, as a treatment for adult and pediatric leukemia and blood cancers.

Under the FDA’s pediatric priority review voucher program, Notable will be able to donate its commercial rights to price, manu-facture and distribute the pediatric form of ND-1000 to the nonprofit, whose mission is to match existing drugs and devices to ap-plications for unsolved diseases.

Baylor Offers New Surrogate Endpoint for Prostate Cancer SurvivalResearchers at Baylor University believe they’ve zeroed in on a surrogate endpoint for survival outcomes for prostate cancer patients: the time to biochemical failure in the disease.

The team analyzed data from the Phase III NRG Oncology/Radiation Therapy Oncology Group 9202 trial, which included about 1,500 men with localized, high-risk prostate cancer.

The trial tested two treatments treatment — short-term and long-term androgen depriva-tion therapy.

Biochemical failure — defined as three consecutive rises in a patient’s prostate-specific antigens — seemed to track along four distinct time landmarks — 12 months, 24 months, 36 months and 48 months after the men complet-ed radiation (or two years after the long-term group completed their androgen-deprivation). The trial found long-term androgen depriva-tion improved the men’s survival rates.

The 24-month biochemical failure status was an accurate predicter of the two different clinical outcomes. The predictive power was even stronger at 36 and 48 months.

Read the team’s findings, published in the Journal of Clinical Oncology, here: https://bit.ly/2DaPzU7.

WCG Acquires MAGI ConferenceWCG Clinical has acquired First Clinical Re-search, organizer of the MAGI conference, in a move the two companies say will help the twice-yearly conference expand its mission of improving communication and sharing best practices among clinical trials professionals.

First Clinical founder and Managing Director Norman M. Goldfarb will remain at MAGI’s helm, “tasked with expanding MAGI’s presence” and “accelerating WCG’s creation of — and participation in — collaborative initiatives that deliver value to the industry,” WCG says.

First Clinical also publishes the Journal of Clinical Research Best Practices, distributed to more than 50,000 subscribers every month.

Page 3: Join the CenterWatch Community CenterWatch group wants to merge real-world evidence and observational evidence from routine clinical practices with patient health - care databases

© 2019 CenterWatch. Duplication or sharing of this publication is strictly prohibited. CWW2305

WCG | CWWeekly February 4, 2019 3 of 7

Features

“If the PI feels there’s inadequate training, that could mean

there are systemic problems in the trial.”

—Dalfoni Banerjee, CEO, 3Sixty Pharma Solutions

all sorts of useful data on PIs’ needs and con-cerns, especially regarding training gaps.

Sponsor training programs may not com-pletely satisfy the FDA’s idea of adequate training, however. All parties involved in a trial should keep their eyes on that elusive definition, Peterson recommends. “Consider how regulators are likely to look at training documentation. Regulators, or trial moni-tors, or auditors, are likely to seek evidence that study employees were trained and qualified for their work,” he says. “It’s always a ‘show me the documentation’ world.”

David Borasky, vice president for IRB compliance at WCG Clinical, says most IRBs have “a baseline expectation” that site staff have at least a basic training on human subjects research.

“There are numerous options, and some IRBs will accept several, and others are more

restrictive,” Borasky says. “This also goes for retraining requirements.”

He adds that “GCP training is similar, but with that different angle that ICH GCP is not the same as research ethics. It’s really about running a clinical trial to a certain standard, and the primary overlap is in requirements for IRB review and consent, which is covered in human subjects training. Human subjects training typically doesn’t linger on ICH GCP things like record keeping and documenta-tion practices. In the world of sponsored

research, this is really more of a sponsor or institutional prerogative than an IRB prerogative.

A growing number of investigators have expressed concern about the gaps in train-ing requirements and training standards that may have a long-term effect on the in-dustry. The constant back-and-forth among sponsors, CROs and sites on what and how to train is creating burnout that investigator advocates call “the one-and-done” problem — PIs that have a bad first trial experience aren’t willing to take on another.

The broader industry is taking notice of the problem. Late last year, the Association of Clinical Research Professionals announced it was drafting recommendations for clearer training rules. Days later, the Clinical Trials Transformation Initiative (CTTI) offered recommendations of their own. Both efforts carried the tacit approval of FDA officials (CenterWatch Weekly, Dec. 3, 2018).

Staff Trainingcontinued from page 1

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ocument review document

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The CRC’s Guide to Coordinating Clinical ResearchThe CRC’s Guide is the most comprehensive, easy-to-read training guide for novice and experienced clinical research coordinators.n Comprehensive review of the CRC role and responsibilitiesn Understanding regulations, GCPs and the IRB rolen Preparing for and closing a clinical studyn Strategies on patient recruitment, engagement and retentionn And much more!

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Page 4: Join the CenterWatch Community CenterWatch group wants to merge real-world evidence and observational evidence from routine clinical practices with patient health - care databases

© 2019 CenterWatch. Duplication or sharing of this publication is strictly prohibited. CWW2305

WCG | CWWeekly February 4, 2019 4 of 7

Features

Speed Trialscontinued from page 1 Healthcare and pharma

investments in Big Data are expected to reach $5.8 billion

by the end of next year, MIT estimates.

The team will be led by the Julia Lab, but housed in CTM.

The project comes at a time when the clinical trials industry is focusing on Big Data analytics in the hope that it can revolu-tionize trials the way it has other business sectors. Healthcare and pharma investments in Big Data are expected to reach $5.8 billion by the end of next year, MIT estimates.

The new collective was announced within days of a new trade group called Align Clinical CRO — consisting of most of the largest CROs

in the market — offering up new operational data-sharing standards that the group hopes will simplify a traditionally thorny problem among sponsors, sites and CROs.

A typical trial spends between $50,000 and $200,000 just creating data extracts and data uploads — translating terms from site to sponsor and back again. Even a seem-ingly simple matter — such as determining when a site is “active” in a trial — can create complications.

The case for patient engagement to improve clinical trialsBy John W. Mitchell, MS

I n the quest to achieve better out-comes, control costs, and improve health under a slew of government

policies and laws in recent years (i.e., the -

able Care Act [ACA]), something un-precedented happened: Clinicians of all stripes began asking: What do patients want?

“Patient engagement is the blockbuster drug of the century,” Farzad Mostashari,

-tional Coordinator of Health Informa-

Phar-maceutical Outsourcing, patient involve-

engagement, which has alternatively been known by many names, including patient centricity and patient activation, refers to the process of involving and empowering patients to improve their healthcare. … Even as patient engage-

ment in clinical trials takes multiple shapes, the end goals are nearly always

The issue of proper documentation in IRB liabilityBy Sue Coons, MA

T he guidance Minutes of Institutional Review Board (IRB) Meetings in

Federal Register describes the requirements for IRB meet-ing minutes and provides recommenda-tions for meeting applicable regulatory

Protections (OHRP) and Food and Drug Administration (FDA). It is intended for institutions and IRBs responsible for oversight of human subject research under HHS and FDA regulations.

However, a court case from the early -

ing IRB meeting activity not only puts IRBs in violation of regulatory standards, but also could put them in legal cross-hairs if research participants are harmed or perceive harm in a clinical trial.

Inadequate documentation in IRB

during FDA inspections, the guidance

FDA’s website for bioresearch monitor-ing (www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm -cies found during IRB inspections to be: inadequate initial and/or continuing review; inadequate written procedures; inadequate meeting minutes and mem-

bership rosters; quorum issues; prompt reporting of noncompliance, suspension/termination; Subpart D issues; and lack of or incorrect risk determination.

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. Volume 19, Number 1

Learning Objectives:

1. List some of the documentation deficiencies FDA is finding in its IRB inspections.

2. Describe the claims plaintiffs in Robertson v McGee made against IRB members.

3. Explain the importance of proper documentation of IRB activities.

4. Discuss the concept of individual liability in IRB decisions.

Learning Objectives:

1. Explain the state of patient engagement in clinical trials.

2. Describe the barriers to and case for patient engagement strategies in clinical trials.

3. List examples of marketing and sales strategies in patient engagement.

4. Discuss the future of patient engagement in clinical trials.

2 CE program information

3 Regulatory update

6 IRB meeting minutes

16 CE post-test

In this issue:

see IRB liability on page 4

see Patient engagement on page 10

se for patient engagement to improve clinical trialschell, l, l MS MS M

to achieve better out-trol costs, and improve er a slew of government ws in recent years (i.e., the

-[ACA]), something un-appened: Clinicians of all sking: What do patients

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sue of proper documentation in IRB liability, MAMAM

ance Minutes of Institutional Board (I(I( RIRI B)B)B Meetingsgsg in

Federal RegRegRe isterrequirements fofof r IRB meet-

and provides recommenda-ting applicable regulatory

OHRP) and Food and Drug on (FDA). It is intended ns and IRBs responsible of human subject research nd FDA regulations. court case frfrf om the early

-

ing IRB meeting activity not only puts IRBs in violation of regulatory standards, but also could put them in legal cross-hairs if research participants are harmed or perceive harm in a clinical trial.

Inadequate documentation in IRB

during FDA inspections, the guidance

FDA’A’As website fofof r bioresearch monitor-ing (wwwwww..ffddffdff aa..ggoovv//vv/vv ScSciieenncceeRReesseeaarrcchh//SSpepecciiaallTTooTToTT ppiiccss//RRuunnnniinnggCClliinniiccaallTTrriiaallss//ddeeffaaffaff uulltt..hhttmm -cies fofof und during IRB inspections to be: inadequate initial and/or continuing review; inadequate written procedures; inadequate meeting minutes and mem-

bership rosters; quorum issues; prompt reporting of noncompliance, suspension/termination; Subpart D issues; and lack of or incorrect risk determination.

Learning Objectives:

1. List some of the documentation deficiencies FDA is finding in its IRB inspections.

2. Describe the claims plaintiffs in Robertson v McGee made against IRB members.

3. Explain the importance of proper documentation of IRB activities.

4. Discuss the concept of individual liability in IRB decisions.

Learning Objectives:

1. Explain the state of patient engagement in clinical trials.

2. Describe the barriers to and case for patient engagement strategies in clinical trials.

3. List examples of marketing and sales strategies in patient engagement.

4. Discuss the future of patient engagement in clinical trials.

see IRB liability on page 4

16 Research Practitioner | January–February 2018

Exam for Continuing Education

Research Practitioner 19.1, 3 Contact Hours

IRB liability and meeting minutes

1. Who did the clinical trial plaintiffs not name in the lawsuit?a. Principal investigatorb. IRB chairc. Nurse coordinatord. IRB members

2. What did the plaintiffs mention in their complaint about the IRB in this clinical trial?a. The IRB failed to examine the

design of the protocolb. The IRB failed to examine the

qualifications of the principal investigator

c. The IRB failed to assure the protection of the participants

d. Both A and Ce. A, B, and C

3. Author Remigius N. Nwabueze argued that:a. IRB members may have

individual liability in the case of harm of a research subject

b. Research institutions protect IRB members from liability

c. IRB meeting documentation has no bearing on potential liability of IRB members

d. None of the above

4. Critical self-examination and internal audits are some of the best ways to catch errors, says attorney Daniel L. Icenogle.a. True b. False

5. Which of the following commonly is observed during inspections of IRB operations?a. Missing minutesb. Inaccurate account of meeting

attendancec. Insufficient or incomplete detail

in minutesd. All of the above

6. Requirements for IRB meeting minutes are found in 21 CFR Part ___:a. 50b. 56c. 312d. 812

7. Although guidance documents are not regulations, when a regulatory authority publishes its current thinking on IRB meeting minutes in a guidance document, it is prudent to use that current thinking to guide your operations. a. Trueb. False

8. Which of the following is useful to guide the preparation of IRB meeting minutes?a. 21 CFR 56.115b. Standard operating procedure

on minutes’ preparation and maintenance

c. A standardized minutes’ template

d. All of the above

9. An IRB is comprised of seven members. At the meeting, four members are present (57%) including a non-scientist and an unaffiliated member. For one hour during the meeting, the non-scientist leaves the room for an hour to take a conference call. For that hour, a quorum technically is still present because the requisite four members were at the start of the meeting. Therefore, any approval vote on a study made during that hour is valid.a. Trueb. False

10. For studies involving children, the IRB would document (in meeting minutes or other IRB record), its discussion of 21 CFR 50 subpart D conditions and approval determination. a. Trueb. False

11. For medical device clinical trials, the IRB would document its device significant risk or nonsignificant risk determination about the study in the minutes.a. Trueb. False

Please note: The website for Research Practitioner exams and evaluations has changed. Please visit the following website which will navigate you to each exam for completion:http://store.centerwatch.com/t-exams.aspx If you have any questions, feel free to email [email protected] or call 866-219-3440.

Requirements for Successful CompletionTo receive contact hours, participants must register, read the full journal and then go to: http://store.centerwatch.com/t-exams.aspx

Read the instructions on this page to register, select an active exam, successfully complete the post-test with a minimum score of 70%, complete the evaluation, and view and print your certificate.

T

Keep your certifi cation up to date Earn up to 18 contact hours accepted by ACRP, SoCRA and CCIP organizations

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CElerion

Contact InformationMichelle Maklas-BakerManager, Global Marketing

Celerion621 Rose St.Lincoln, NE 68502USA

+1.402.476.2811+1.402.939.0428 (fax)

[email protected]

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View By: Company Type Services

• Overview• Global Clinical Research• Data Management and Biometrics• Global Bioanalytical Services• Drug Development Services• Facilities• Thought Leadership• Contact Company

OverviewCelerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 40 years' experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept and dose response in

Celerion

• Overview• Global Clinical Research• Data Management and Biometrics• Global Bioanalytical Services• Drug Development Services• Facilities• Thought Leadership• Contact Company

OverviewCelerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information

View By:

Celerion

Contact Information

• Overview• Global Clinical Research• Data Management and Biometrics• Global Bioanalytical Services• Drug Development Services• Facilities• Thought Leadership• Contact Company

OverviewCelerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

Michelle Maklas-BakerManager, Global Marketing

Celerion621 Rose St.Lincoln, NE 68502USA

+1.402.476.2811+1.402.939.0428 (fax)

[email protected]

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WCG | CWWeekly February 4, 2019 6 of 7

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactDicerna Pharmaceuticals, Inc.

DCR-HBVS chronic hepatitis B virus (HBV) Phase I trial initiated enrolling healthy volunteers and subjects with non-cirrhotic chronic HBV

dicerna.com

Navitor Pharmaceuticals, Inc.

NV-5138 Treatment-Resistant Depression (TRD)

Phase Ib trial initiated enrolling up to 88 subjects, including healthy volunteers and those diagnosed with TRD

navitorpharma.com

Theravance Biopharma, Inc.

ampreloxetine (TD-9855)

symptomatic neurogenic orthostatic hypotension (nOH)

Phase III trial initiated enrolling 188 subjects with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson's disease (PD) and pure autonomic failure (PAF)

theravance.com

Qualigen, Inc. FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay

diagnosis and treatment of men's health

510(k) clearance granted by the FDA

qualigeninc.com

Merck V114 prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age

Breakthrough Therapy Designation granted by the FDA

merck.com

C2N Diagnostics brain amyloidosis blood test

screening for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis

Breakthrough Device Designation granted by the FDA

c2ndiagnostics.com

BioInvent International AB

BI-1206 mantle cell lymphoma (MCL) Orphan Drug Designation granted by the FDA

bioinvent.com

Eureka Therapeutics, Inc.

ET140202 ARTEMIS T-cell therapy

AFP-positive patients with advanced hepatocellular carcinoma (HCC)

IND approval granted by the FDA

eurekatherapeutics.com

MGB Biopharma MGB-BP-3 Clostridium difficile-associated diarrhea (CDAD)

IND approval granted by the FDA

mgb-biopharma.com

CorMatrix Cardiovascular, Inc.

Cor TRICUSPID ECM cardiac valve

adults with endocarditis and for pediatric patients with congenital heart valve disease

IDE approval granted by the FDA

cormatrix.com

Amerigen Pharmaceuticals, Limited

generic version of Shire's Adderall XR (dextroamphetamine saccharate,amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules)

attention deficit hyperactivity disorder (ADHD)

ANDA approval granted by the FDA

amerigenpharma.com

Dr. Reddy’s Laboratories Ltd. and Promius Pharma, LLC

TOSYMRA (previously known as DFN-02)

acute treatment of migraine with or without aura in adults

NDA approval granted by the FDA

drreddys.compromiuspharma.com

AbbVie and Janssen Pharmaceutical Companies of Johnson & Johnson

IMBRUVICA (ibrutinib) in combination with Roche’s obinutuzumab (GAZYVA)

adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

NDA approval granted by the FDA

abbvie.comjanssen.com

For news on trial results, FDA approvals and drugs in development, Join the LinkedIn Drug Research Updates group!

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Upcoming Event Highlights

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

[ V IE W ALL JOB L IST INGS ]

The Source for Clinical Research Jobs and Career ResourcesJobWatch

Academic Programs

[ V IE W ACADEMIC PR OGR AM D E TA ILS ]

Boston College Clinical Research Certificate ProgramChestnut Hill Campus, Newton, MA

Drexel University College of Medicine Master’s/Certificate Programs in Clinical Research Organization and ManagementOnline

University of North Carolina at Wilmington MS Clinical Research and Product DevelopmentOnline

More Jobs

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Conferences

F E B R UA R Y 1 9 - 2 0 , 2 0 1 9 Medical Device Risk ManagementAtlanta, GA

M A R C H 2 6 - 2 7 , 2 0 1 9 Conducting Advanced Root Cause Analysis and CAPA InvestigationsRaleigh, NC

M A R C H 2 7 - 2 8 , 2 0 1 9 ICH GCP E6 R2 Meeting CRO-Vendor Oversight RequirementsRaleigh, NC

A P R I L 8 - 1 2 , 2 0 1 9 FDA Compliance Boot Camp 2019Frederick, MD

A P R I L 1 5 - 1 8 , 2 0 1 9 18th Annual Design of Medical Devices ConferenceMinneapolis, MN

A P R I L 2 3 - 2 5 , 2 0 1 9 Medical Device Quality CongressBethesda, MD

O C TO B E R 2 3 - 2 5 , 2 0 1 9 FDA Inspections SummitBethesda, MD

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Webinars

F E B R UA R Y 1 3 , 2 0 1 9 Building a World-Class Drug Supply Chain: Tips for Compliance and Digital TransformationEvren Ozkaya — founder and CEO of Supply Chain Wizard, LLC — will discuss laying down a digital sup-ply foundation with track-and-trace capabilities at the center of the systems and processes.2:30 p.m. – 3:30 p.m. EST

[ V IE W A LL WEB INAR S ]

Research Associate Gaithersburg, MD

Data Scientist I- Epidemiology and Health Economics New Brunswick, NJ

Team Supervisor Wilmington, MA

Senior Statistical Programmer Seattle, WA

Clinical Data Associate I Foster City, CA

Clinical Business Analyst Lansdale, PA

Microbiologist Miami Gardens, FL

CR45 - Medical Writer III Pleasanton, CA

Clinical Research Coordinator IIEmory University Atlanta, GA

Clinical SAS ProgrammerLean-IT Solutions Woodcliff Lake, NJ

Research Associate IIKaiser Permanente Fontana, CA

Manager, Clinical OperationsNantKwest Cary, NC

Clinical Trial AssociateTCR2 Therapeutics Cambridge, MA

Clinical Trials AssistantCommonwealth Sciences Canton, MA