Creating a Program to Support Registering and Reporting Clinical Trials at Johns Hopkins University

Bibliographic Data

ID21613498
AuthorsAnthony Keyes (0000-0001-8585-9604, A. Keyesis research program manager, Johns Hopkins University School of Medicine, Baltimore, Maryland., corresponding author), Evan Mayo-Wilson (E. Mayo-Wilsonis associate professor, Department of Epidemiology and Biostatistics, Indiana University School of Public Health–Bloomington, Bloomington, Indiana), Evan Mayo‐Wilson (0000-0001-6126-2459, E. Mayo-Wilsonis associate professor, Department of Epidemiology and Biostatistics, Indiana University School of Public Health–Bloomington, Bloomington, Indiana.), Prince Nuamah (P. Nuamahis clinical research compliance specialist, Johns Hopkins University School of Medicine, Baltimore, Maryland.), Aliya Lalji (0000-0003-3552-8908, A. Laljiis clinical research operations specialist, Johns Hopkins University School of Medicine, Baltimore, Maryland.), Oswald Tetteh (0000-0003-2509-1810, O. Tettehis clinical research compliance specialist, Johns Hopkins University School of Medicine, Baltimore, Maryland.), Daniel E Ford (0000-0002-2549-2289, D.E. Fordis professor of medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.)
Year2021
Volume96
Issue4
Pages529-533
Publication date2021-04-01
Open AccessNo
TypeARTICLE
VenueAcademic Medicine (JOURNAL)
Journal identifiersISSN: 1040-2446 • E-ISSN: 1938-808X
PublisherOxford University Press (OUP) (PUBLISHER)
DOI10.1097/acm.0000000000003806
PMID33060401
OpenAlexW3093084871
LanguageEN
Citations received1
References cited4

PROBLEM: The Food and Drug Administration Amendments Act of 2007 (FDAAA) and the National Institutes of Health (NIH) require that many clinical trials register and report results on ClinicalTrials.gov. Noncompliance with these policies denies research participants and scientists access to potentially relevant findings and could lead to monetary penalties or loss of funding. After discovering hundreds of potentially noncompliant trials affiliated with the institution, the Johns Hopkins University School of Medicine (JHUSOM) sought to develop a program to support research teams with registration and reporting requirements. APPROACH: JHUSOM conducted a baseline assessment of institutional compliance in 2015, launched the ClinicalTrials.gov Program in June 2016, and expanded the program to the Sidney Kimmel Comprehensive Cancer Center in April 2018. The program is innovative in its comprehensive approach, and it was among the first to bring a large number of trials into compliance. OUTCOMES: From September 2015 to September 2020, JHUSOM brought completed and ongoing trials into compliance with FDAAA and NIH policies and maintained almost perfect compliance for new trials. During this period, the proportion of trials potentially noncompliant with the FDAAA decreased from 44% (339/774) to 2% (32/1,304). NEXT STEPS: JHUSOM continues to develop and evaluate tools and procedures that facilitate trial registration and results reporting. In collaboration with other academic medical centers, JHUSOM plans to share resources and to identify and disseminate best practices. This report identifies practical lessons for institutions that might develop similar programs

Clinical trial · Family medicine · Medical education · Trial registration · Biomedical Ethics and Regulation · Ethics in Clinical Research · Medicine · Psychology · Statistical Methods in Clinical Trials

Tools

Open DOIOpen Access