Why compliance with ClinicalTrials.gov is so important for researchers

Clinical researchers at the University at Buffalo, including many affiliated with the UB Clinical and Translational Science Institute (CTSI), must frequently use ClinicalTrials.gov to post clinical research studies and information about their results. The online registry is linked to a public website that serves as a database for researchers and for individuals interested in participating in research globally. Compliance with ClinicalTrials.gov is routinely emphasized at UB, since failure to comply has major consequences.

“It is essential that all of our clinical researchers use ClinicalTrials.gov — and use it properly,” says UB CTSI Associate Director Sanjay Sethi, MD, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine, and Assistant Vice President for Health Sciences, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, and Director of UB’s Clinical Research Office.

Compliance matters

As outlined in the CTSI Educational Module titled “ClinicalTrials.gov: Entering Results,” reporting of study results:

• Provides a public record of basic study results in a standardized format for researchers, journal editors, Internal Review Boards, and other relevant consumers of research information
• Promotes the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledge for patients, the research community, and the public
• Reduces publication and outcome reporting biases for the benefit of users of the medical literature
• Facilitates systematic reviews and other analyses of the research literature for researchers and policymakers

“ClinicalTrials.gov is a valuable resource for anyone who is interested to know about clinical trials,” says Pam Anderson, Associate Director, Clinical Research Office. “Potential participants may also use the website for an alternative to the standard treatment offered. The website is offered to the public as a national database and source of information for studies conducted around the world so it is vital that compliance is adhered to so the results can be shared.”

According to FDA.gov, noncompliance may result in letters to notify investigators. These violations include failure to register an applicable clinical trial; failure to submit required clinical trial information for an applicable clinical trial; and submission of false or misleading clinical trial information.

Investigators have 30 days to comply or respond to the FDA prenotification letter to avoid potential financial penalties. The current maximum penalty amount — $14,262 per day of non-compliance — is substantial. For an NIH-funded study, failure to submit required results information could result in NIH not releasing remaining funding for a grant or funding for a future grant.

ClinicalTrials.gov FAQs and resources

To inform researchers on the ins and outs of ClinicalTrials.gov, and to assist with compliance, the CTSI is undertaking a series of “FAQ” articles as part of its ongoing “Research Roundtable” articles. The first of a two-part series on study registration is posted now, with part two as well as a series on study results entry to follow in the coming weeks.

In addition, the CTSI has developed educational videos to assist investigators and research staff as they navigate ClinicalTrials.gov. These Educational Module resources include:

• ClinicalTrials.gov: Does Your Study Need to be Registered?
• ClinicalTrials.gov: Entering Results
• ClinicalTrials.gov: How to Register Your Trial

A downloadable ClinicalTrials.gov Registration and Results Guide is available as part of the CTSI Recruitment Resources Toolkit.

UB has a ClinicalTrials.gov help team (UBClinicalTrialsgov@buffalo.edu) that offers continuous support to investigators who need assistance with account setup or have questions with registering their trial and/or entering the results into the ClinicalTrials.gov repository. Also available to assist with registration and reporting requirements are ClinicalTrials.gov Protocol Registration and Results System Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.