Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S.
Specifically, FDA is introducing a pilot program that will publish “clinical study reports” – reports prepared by drug sponsors that provide “bottom line information” on both the methods and results of clinical trials. The announcement acknowledges that while currently summaries written by FDA’s medical reviewers are released by FDA when a drug is approved, the format might challenge stakeholders who are looking for information.
The pilot program, to begin this month, will involve the posting of portions of clinical trail summaries from the pivotal trials that were submitted by FDA from drug sponsors and will involve the summaries of 9 companies who volunteer the use of their new drug applications and that participation will include a range of therapeutic categories.
One thing not mentioned in the announcement was the issue of complete response letters (CRLs). For a long time now, many stakeholders have advocated that CRLs, now considered proprietary, be made public in the interests of greater transparency.
Other questions with respect to the program that were not addressed in the announcement were its anticipated length – how long the program will take to have 9 volunteers, and any outline as to how the success of the program will be evaluated and what steps, if successful, will be taken to make the program permanent. Finally, if made permanent, would participation continue to be on a volunteer basis?
For many stakeholders, as seen in some of the response on Twitter, this initiative is not going far enough and there are critics who feel it needs to be a broader effort, especially with respect to the CRL issue. One thing, however, that is clear (pun intended) when it comes to transparency is that when you open the door a little, it is pretty hard to close it again. With the advent of the pilot program, it would seem difficult for FDA to go back unless the evaluation of this pilot is absolutely dismal. The arc of progress is with greater transparency.
If interested, there was also a panel discussion held yesterday morning by the Johns Hopkins Bloomberg School of Public Health – A Forum on Transparency at the U.S. FDA that included two panels and a keynote from Commissioner Gottlieb.