A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
Launched in 2000, ClinicalTrials.gov houses registration data for all trials regulated by the FDA, currently numbering more than 175,000 trials. Current regulations require drug companies to submit summary results (number of participants, age and gender, outcomes, and adverse events) within 1 year of trial completion for drugs and devices which receive approval. Under the new rule proposed by HHS, companies will also be required to report results for unapproved products, adding a significant amount of publicly available data to the site. Phase I trials, designed to test the safety of a drug or medical device do not fall under the provisions of the proposal. However, the NIH also plans to put in place a rule that requires submission to ClinicalTrials.gov results from all clinical trials that it funds, no matter how early or small.
Sharing Clinical Trial Data for Unapproved Compounds: Why the Change?
A recent analysis of 400 U.S. clinical trials found that even four years after the trials had been completed, nearly 30% had failed to share results by publishing in a scientific journal or reporting in ClinicalTrials.gov 1. Furthermore, negative clinical trial results are far less likely to make it into the scientific literature compared to positive results. Nonetheless, these data encompass a large number of studies and are important to clinicians, scientific research, and the general public.
Here are three reasons you should care about negative results from a clinical trial:
Sharing Negative Results is Useful for Scientific Research
When it comes to clinical trials (and scientific research), transparency with data helps researchers avoid duplicating failed trials. This directly reduces the risk for clinical trial participants, who are entrusting their health and well-being to the trial process. Negative results also help guide future research and the design and implementation of improved trials, eliminating redundant scientific work for which an answer already exists (just not in a published form).
Sharing Negative Results Helps Fulfill Society’s Ethical Responsibility to People Who Volunteer for Trials
The clinical trial process (and thus approval of all drugs) relies on the voluntary participation of human subjects. Often times, participants join a trial not just for the potential benefit of personal treatment, but also for the possibility of improving the lives of others down the road. Sharing clinical trial data helps to maximize the potential benefit of each trial and helps to justify the participation of each human subject who has donated their time and efforts to the clinical trial process.
Increase in Public Trust
An increase in the transparency of clinical trial data will help foster an increase in trust between the general public and drug developers. Sharing clinical trial data with the worldwide scientific community in an open and efficient manner will also increase trust between the American taxpayers and the National Institutes of Health (NIH), who use their funds to help sponsor many clinical trials.
The HHS and the NIH are taking public comment on the two proposed policies until February of next year. It will be interesting to see the responses to this proposed change in reporting clinical trial data. What do you think?
1 Saito H and Gill CJ. PloS One. 2014 Jul 15; 9(7).