Join the CenterWatch Community! CenterWatch August 19, 2019 Weekly Industry Briefs…2 Up and Coming…3 Drug & Device Pipeline News…7 Industry Seeks More Detail from FDA Guidance Nine drugs and devices have entered a new on Trial Diversity trial phase this week. By Colin Stoecker Roche/Genentech wrote, such as those JobWatch…8 he FDA’s draft guidance on broaden- with other conditions, unique racial ing eligibility criteria and increasing characteristics and varying age and diversity in clinical trials needs more body profile. T CLINICAL TRIAL RISK definition and depth, according to drugmak- In addition to sponsors, CROs and aca- AND PERFORMANCE ers, clinical trial organizations and patients demic research centers, more than half of MANAGEMENT SUMMIT responding to the agency’s call for com- the comments were from individuals, many ments on the document. representing the EndBrainCancer Initiative, A common theme in the 90 separate a patient advocacy organization. The draft comments on the guidance was the lack of guidance, Enhancing the Diversity of Clini- SEPT. 4–5, 2019 REGISTER TODAY clarity on how to determine a representative cal Trial Populations, was issued in June PHILADELPHIA participant sample. Several commenters (CenterWatch, June 10, 2019). asked the FDA to develop a statistical model The FDA needs to “more clearly eluci- NEW WHITE PAPERS AVAILABLE or metric to help sponsors design trials date the scientific reasons for its focus on An Actionable Approach An Actionable Approach to Decentralized Clinical Trials to and set eligibility criteria that result in an diversity,” the Brigham and Women’s Hos- Grow Enrollment and Retention to Decentralized adequate patient sample. pital’s Multi-Regional Clinical Trials Center Clinical Trials to Grow Enrollment and Retention Broadening eligibility could open tri- (MRCT) said. From Symphony Clinical Research als to more medically complex patients, see Industry Seeks on page 4 » Melissa Hawking Symphony Clinical Research June 2019 LEARN MORE Ask the Expert: Sub-Investigator Compensation centerwatch.com/whitepapers Answer: his monthly feature presents a variety of The Sunshine law in Florida requires that questions from clinical trial profession- 1) meetings of boards or commissions must als with answers from WCG Clinical’s ex- be open to the public; 2) reasonable notice T The CRC’s Guide to Coordinating pert staff. To ask a question of WCG’s experts, of such meetings must be given; and 3) min- The CRC’s Guide Clinical Research to Coordinating Clinical Research click here: https://bit.ly/2XB9F6R. utes of the meeting must be taken. There is Stay informed and be Question: no mention of payments to investigators or prepared to respond to industry changes. We are planning on using a sub-inves- sub-investigators. FOURTH EDITION Sandra “SAM” Sather, MS, CCRC tigator to support a clinical trial at our site. However, under the Centers for Medi- ORDER TODAY What do we need to include in the contract care & Medicaid Services Open Payments to ensure that we are compliant with the Program, there is a national disclosure Florida Sunshine law and the Stark law? requirement by making the financial Should we explicitly state in the contract relationships between applicable manufac- May–June 2018 42 CE program information 43 Issues in research management 52 SMART IRB Learn about best practices 55 CE post-test that we are compensating the sub-investi- turers, such as pharmaceutical companies Emerging trends in clinical research: The need for change By John W. Mitchell, MS to eectively manage and o understand the opportunity oered don’t know what we don’t know.” Learning Objectives/Outcomes: by emerging trends in the clinical trial In recent issues, Research Practitioner has 1. Explain the need for change in clinical research. research sector, consider insight from explored individual key emerging trends in T 2. List key drivers of transformation in clinical trials. a business author and a businessman/politi- clinical research, including patient centricity, 3. Describe examples of clinical trial research trends in cian. In his groundbreaking book, Good eMobile advances, and precision medicine. action. to Great: Why Some Companies Make the As stand-alone trends, these innovations 4. Discuss why the clinical trial sector will make the execute clinical trials with Leap…And Others Don’t,” Jim Collins wrote: hold great promise and excitement. jump from trends to practice. “Good is the enemy of great. And that is But what insight is gained when all emerg- one of the key reasons why we have so little ing trends are considered in totality? What gator for services and that we are not paying and healthcare providers, available to the that becomes great. We don’t have great do these opportunities say about the eld of ese seem to be fair questions. In a Feb- schools, principally because we have good clinical research? As Rumsfeld alluded, what ruary 2017 CenterWatch article about survey schools. We don’t have great government, might we not know that we don’t know? Are results on the use of electronic-sourced principally because we have good govern- current advancements in clinical research, as data, Hugo Stephenson, executive chairman the Research Practitioner. ment.” Collins asserted, relevant enough to power of DrugDev and a physician investigator, In a 2002 Department of Defense brieng, (great) the sector beyond the status quo observed: “I’m surprised and disappointed Secretary Donald Rumsfeld noted that one (good), given the rapidly evolving medical there hasn’t been much improvement in the of the biggest threats to security was driven reality of interconnectivity, articial intel- entire clinical trial process, including the by factors that fell under the category of “we ligence (AI), and the expectation of patients? for subject referrals? What is a good com- public. Under the Open Payments pro- see Emerging trends on page 44 Caution for NIH's single IRB policy for multi-site research By Sue Coons, MA » Earn ANCC contact hours Learning Objectives/Outcomes: s of Jan. 25, 2018, research institu- It does not apply to career development, 1. List the details that local IRBs may know about their tions had to comply with the National research training, or fellowship awards. study populations as opposed to a single IRB. Institutes of Health’s (NIH’s) Final However, some institutions continue to 2. Describe NIH’s reasoning for going to a single IRB A policy for multi-site research. NIH Policy on the Use of a Single Institutional be concerned about their ability to adhere 3. Discuss the impact of using a single IRB on a study’s Review Board for Multi-Site Research is to the policy and the cost of doing so. IRB direct costs. policy established the expectation that a executives say it is wise to be cautious. Some 4. Explain the concern about NIH’s history of choosing pensation for a sub-investigator? — Staff at gram, you are required to report only the single institutional review board (sIRB) of institutions could spend millions of dollars the lowest-cost provider. » Maintain nursing certication record would be used in the ethical review to upgrade their IRB infrastructure, while of non-exempt human subjects research some IRBs already have many of the policy protocols funded by NIH that are carried out requirements in place. In addition, one IRB show that the agency could revise its policy at more than one site in the United States. executive worries that past NIH actions see Single IRB on page 49 research site see Ask the Expert on page 5 » © 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited. Volume 19, Number 3 » Subscriptions at $197 DOWNLOAD A SAMPLE Volume 23, Issue 31. © 2019 CenterWatch. All rights reserved. WCG | CWWeekly August 19, 2019 2 of 8 Industry Briefs FDA Proposes Endpoints for IQVIA Patient Portal Provides from real-world evidence. By adding Compre- Gastroparesis Trials Real-World Trial Results hend’s Clinical Intelligence Platform, Saama The FDA has named five acceptable end- IQVIA’s new patient portal will give trial will increase its support of CROs. Under Saama, points for trials of gastroparesis treatments in participants a window into the clinical research Comprehend will partner with Rockville, a draft guidance released last week. process by giving them access to their lab Maryland-based CRO DP Clinical to deploy its The agency says that five core signs and results and other study-related information. centralized trial monitoring software tool. symptoms of the disease that prevents Participants in trials that use the Patient proper emptying of the stomach should be Portal are offered access when they are re- Signant Program Supports used as primary endpoints: nausea, vomit- cruited. Throughout the trial, they receive visit CRO-Sponsor Communication ing, fullness after a meal, early satiety and and medication reminders, disease education Signant Health’s new partner program abdominal pain. and travel support services. teams with CROs to help them improve com- Sponsors should provide a primary end- The Patient Portal is part of IQVIA’s suite of munication with and service to sponsors on all point definition and a method for measur- trial support tools but also can be used as a aspects of clinical trial management. ing each of the five signs and symptoms stand-alone solution. The program will provide support on described in the guidance. For example, the protocol design and optimization, data quality agency recommends that all signs be given a FDA Collaboration Pulls RWE in oversight, patient engagement, eConsent and rating of severity, except for vomiting, which Clinical Oncology Trials clinical supply management. Signant also will should be measured in terms of the number Syapse and the FDA’s Oncology Center for offer its partners exclusive commercial terms, of times it occurs over a 24-hour period.