Posted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which are summaries of clinical trial data, only one company has provided any information about a drug.
As a result, a group of academics is concerned the effort has stalled and is calling on the agency to make such disclosures mandatory.
Clinical study reports help form the basis for regulatory approval decisions, but disclosure has long been a flashpoint among researchers and drug makers, prompting heated debate about patient privacy, trade secrets, and improving medical research.
