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

Area of Science:

• Clinical research administration
• Regulatory compliance in medicine
• Biomedical informatics

Background:

• The Food and Drug Administration Amendments Act (FDAAA) and National Institutes of Health (NIH) mandate clinical trial registration and results reporting on ClinicalTrials.gov.
• Noncompliance can hinder access to vital research findings and result in penalties, impacting participants and the scientific community.
• Johns Hopkins University School of Medicine (JHUSOM) identified a significant number of noncompliant trials, necessitating a structured support program.

Purpose of the Study:

• To establish and implement a program at JHUSOM to ensure research teams meet clinical trial registration and reporting requirements.
• To improve institutional compliance with FDAAA and NIH policies for both ongoing and new clinical trials.
• To serve as a model for other academic medical centers facing similar regulatory challenges.

Main Methods:

• A baseline compliance assessment was conducted in 2015.
• The ClinicalTrials.gov Program was launched in June 2016 and expanded in April 2018.
• The program focused on comprehensive support for trial registration and results reporting.

Main Results:

• Institutional compliance with FDAAA and NIH policies significantly improved between September 2015 and September 2020.
• The proportion of potentially noncompliant trials decreased from 44% to 2%.
• High compliance rates were maintained for newly initiated trials.

Conclusions:

• JHUSOM successfully developed and implemented an effective program to enhance clinical trial compliance.
• The program demonstrates a practical approach for institutions to meet regulatory obligations.
• Lessons learned are being shared to promote best practices in clinical trial management and reporting.