Effective September 26,2012 Health and Human Services has assigned responsibility to FDA for enforcing reporting by sponsors on ClinicalTrials.gov. Based on a notice by the Federal Register, FDA is now responsible for keeping track of the database’s most recent developments, which includes studies currently in progress and those that have been completed. FDA is also charged with ensuring the accuracy of the data submitted. Although the question of whether or not sufficient funding for this project is present, clinical trials could see a tremendous increase in completion of reporting on this valuable database. In a recent article from Outsourcing-pharma.com, Congressman Edward Markey shared that there are a number of unreported results and missing registrations that leave “participants, doctors and researchers vulnerable.” With FDA overseeing the clinicaltrials.gov reporting, research participants might feel a greater sense of security.
To read more on the FDA’s new responsibility, click here.