30 Aug Faster drug approvals by FDA raise concerns about transparency and beneficence in clinical trials

By David Morin, Holston Medical Group via The Association of Clinical Research Professionals (ACRP)

With recent studies from Oregon State University (OSU) raising essential points about drug safety and research transparency in an era when the U.S. Food and Drug Administration (FDA) seems to be approving drugs after fewer trials (accelerated approval) and releasing less data from those trials, one experienced principal investigator (PI) cautions that public perceptions of clinical research may take a hit.

According to the OSU research, the FDA is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago. Read more …