- The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) are proposing forcing drug makers to put all clinical trial data (and not just data for successful trials) online, excluding phase I and feasibility studies.
- Currently, drug sponsors are only required to post clinical trial results for approved drugs—about 15,000 trials—on Clinicaltrials.gov, but under proposed regulations, results from all of the roughly 178,000 clinical trials underway will have to be posted. The goal: full-on transparency.
- Responses to the proposal are currently being solicited during a 90-day window, via Regulations.gov.
The impetus for clinical trial transparency is making clinical trial results available to researchers and to the public at large—and not just results for approved drugs.
There's been a worldwide push for greater transparency, with companies like GSK and J&J agreeing to provide results for all trials. Other companies, such as Sanofi and Bayer, however, are holding back. But one thing's for sure: the movement for increased clinical trial transparency will continue unabated until regulators—and the public at large—are satisfied.