An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

• Published in: Therapeutic innovation & regulatory science 2019-03, Vol.53 (2), p.190-192
• Main Authors: Kelly-Pumarol, Issis, Andrews, Joseph E.
• Format: Article
• Language: English
• Subjects: Clinical trials; Clinical Trials as Topic - standards; Clinical Trials: Commentary; Colleges & universities; Compliance; Databases, Factual; Drug Safety and Pharmacovigilance; Guideline Adherence; Health policy; Leadership; Legislation, Drug; Medical research; National Institutes of Health (U.S.); Pharmacotherapy; Pharmacy; Researchers; United States; United States Food and Drug Administration - legislation & jurisprudence
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1177/2168479018778284

Recent National Institutes of Health policy changes have expanded the number of research studies that must be registered in clinicaltrials.gov beyond the requirements of the Food and Drug Administration Amendments Act of 2007. The International Committee of Medical Journal Editors has also adopted a policy that requires registration of research in a public database. The goal was to increase the transparency of research by reporting the original endpoints of a study, and to discern whether primary endpoints were excluded in subsequent publications. Efforts to increase openness and accountability in clinical trials are likely to strengthen public trust. However, first investigators and study staff must be educated about the requirements, and staff must be prepared to offer support to researchers in navigating the clinicaltrials.gov system. For academic institutions, maintaining compliance requires continuous oversight so that problems can be identified centrally and addressed with investigators. At Wake Forest University Health Sciences, because researchers often did not realize they were out of compliance, we implemented a program to assist them and provide oversight. We introduced standard operating procedures, provided education and assistance to investigators, and engaged leadership about consequences of compliance, resulting in increased budget support for a full-time employee in this role. As a result of these changes, compliance increased from 22% to 92% over 4 months. These approaches may help other institutions become compliant with registration requirements more quickly.