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The Importance of Improving ClinicalTrials.gov Compliance

CITI Program 12 February 2020 by CITI Program

For two decades, the federal government has encouraged transparency in research. As a result of these efforts, it established ClinicalTrials.gov, a national registry of U.S. clinical trials. The objective was to improve public trust in research and to help potential participants find appropriate trials. Since then, researchers are also required to post summary results in order to improve overall transparency in research.

Both the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) require registration of clinical trials at ClinicalTrials.gov, as well as disclosing the results of those trials. For the FDA, all applicable clinical trials (ACTs) that were initiated after September 27, 2007 must be registered. Trials that were started before then, but are ongoing as of December 2007, are also required to be posted. The National Institutes of Health (NIH) requires registration at ClinicalTrials.gov for all clinical trials funded wholly or partially by NIH.

Additionally, most medical journals, including member publications of the International Committee of Medical Journal Editors (ICMJE), require registry as a condition of publication.

Institutions and sponsors not meeting their obligations

Despite these requirements, many sponsors and investigators are not complying. A study published in January in the journal Science showed that 16 percent of sponsors, institutions and medical centers had failed to report any results for 67% of their trials. Surprisingly, academic medical centers performed far more poorly in reporting on time or at all compared to sponsors.

A study published last month in Lancet showed similar results.

Implications for non-compliance

The fines can be hefty for non-compliance. Institutions and sponsors face penalties of up to $12,103 a day for failing to report a trial’s results. But compliance is more than a regulatory burden or administrative task. More importantly, this lack of compliance can have serious implications on health and the practice of medicine. When clinicians and patients do not have access to the latest research findings, it impedes their ability to make the best treatment decisions.

Investigators may find it challenging to post research findings. Submitting summary results can be more complex and time-consuming than registering a protocol.

Help for institutions and investigators

CITI Program offers two online education opportunities to learn how to establish a reporting program to comply with regulations related to ClinicalTrials.gov.

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov
This course guides clinical research teams through current regulations and how they impact clinical research teams. It also reviews how to enter and maintain protocol registrations and summary results information.
View Course Details

Building a ClinicalTrials.gov Compliance Program – Tips for Investigators and Institutions
This webinar covers a brief overview of the regulations, important timelines to follow, agency-specific variances, and a range of compliance mechanisms. It also covers the specific steps a major university took to build a successful compliance program to assist investigators.
View Webinar Details