One year after the Food and Drug Administration 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. However, regulators in other countries had taken steps to disclose these reports and the FDA touted the program as its own bid to provide greater transparency.
By releasing such information, the agency hoped to make it possible for the public to better understand clinical trial methods and results, and also help other researchers replicate or expand upon the findings. Toward that end, the agency signaled optimism that drug makers would voluntarily comply and up to nine separate clinical study reports would become available, although no timeline was offered.