MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner.
Published in:Therapeutic Innovation & Regulatory Science
The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.
MRCT Center colleagues author an article in JAMA Network Open with Dr. Tony Tse.
Presented on: November 18, 2021
Published by:JAMA Network Open
MRCT Center Executive Director Sarah White, Senior Advisor Luke Gelinas, Project Manager Walker Morrell, Faculty Director Barbara Bierer, and Program Director Deb Zarin authored an article in JAMA Network Open with Dr. Tony Tse: “Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.”
