Registering and Reporting COVID-19 Clinical Research Results to ClinicalTrials.gov

With scores of COVID-19 and SARS-CoV-2 clinical trials underway, the NIH continues to stress the importance for researchers to register their trials on ClinicalTrials.gov as soon as possible.

 

National Institutes of Health (NIH) director, Dr. Francis Collins, released a memo in November urging researchers to report their research findings on ClinicalTrials.gov ahead of the regulatory deadline requirements. In an effort to expedite the process to report, the agency prioritizes COVID-19 trials to make them available within days of submission.

 

“The scientific community bears collective responsibility for expediting the dissemination of knowledge from NIH-funded research. Doing so will bring COVID-19 treatments and vaccines to the American public and the world as quickly as possible,” says Collins.

 

A recent New York Times article discussed the struggles of some institutions to comply with the now 14 year old rule requiring research institutions to report their findings. In 2017, the Food and Drug Administration announced that failing to comply can result in fines, some exceeding $11,000 per day, for each study failing to report results. As vaccines and therapeutics are being developed and authorized for emergency use, the need for timely reporting is imperative.

The ICTR ClinicalTrials.gov program guides investigators through the registration and reporting process to avoid such fines. We’ve created checklists to review submissions and we have administrators throughout the University with access to records and institutional accounts.

If you have questions or need assistance in registering your trial, please contact Anthony Keyes at registerclinicaltrials@jhmi.edu.

 

Read more:

ClinicalTrials.gov

NIH Calls on Clinical Researchers to Swiftly Share COVID-19 Results

Johns Hopkins University Achieves 100% Compliance with a Federal Law Designed to Reveal Clinical Trial Results