Report: increasingly complex trial designs come at a cost

The expanding scope and complexity of clinical trial protocol designs are increasing trial costs and reducing efficiency, which may be contributing to rising drug costs, according to a report from the Tufts Center for the Study of Drug Development.

FDA Commissioner Scott Gottlieb and other senior FDA officials have expressed concern that sponsors are increasing the costs and time required to develop drugs by gathering and submitting data that isn’t necessary to support NDAs and BLAs. ...