FDA Plans Effort to Lower Costs of Clinical Trials (1)

The nation’s chief drug regulator wants to scale back the work of a $40 billion clinical trial outsourcing industry that he said is bloating costs without enough additional benefit.

The Food and Drug Administration will roll out a plan to decrease the burden of conducting clinical trials, FDA Commissioner Scott Gottlieb said Nov. 13. Such studies can cost as much as $22 million for an oncology trial used to approve a new drug, for example.

The goal is to “democratize the ability to conduct clinical trials,” he said. This can be achieved by expanding the reach beyond hospitals and universities ...