FDA Close to Unveiling Policies Addressing ‘Unnecessary’ Clinical Trial Quality Control Efforts

FDA Commissioner Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD

Look for the U.S. Food and Drug Administration (FDA) to roll out some specific policies aimed at reducing burdens on the conduct of clinical trials “very soon,” FDA Commissioner Scott Gottlieb, MD, said at an event sponsored by the Washington Post earlier this week.

“A lot of the costs of clinical trials are QC [quality control] related” and aren’t always necessary in a digital age where it’s possible to collect information and conduct audits more easily, Gottlieb said. Beyond adding arguably unnecessary workload, he posited that it wasn’t “doing much to add to the integrity of the data.”

Left unchecked, these burdensome activities are making it harder for trials to be conducted in “community settings,” Gottlieb said.

Easing trial burdens is part of a broader FDA effort to “democratize” the ability to conduct clinical trials in a wider variety of locations and under various scenarios. “I think we can roll a lot of that back,” Gottlieb said.

“We’re excited by the commissioner’s comments,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). “It appears the FDA is planning to issue guidances to promote the use of remote monitoring in clinical trials, and that will help make trials more efficient.”


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Kremidas also suggested FDA’s position is further evidence that the changing role of the clinical research associates (CRAs) who monitor trials on behalf of sponsors or contract research organizations will call for additional skills, including data analytics. “The role of the CRA is clearly evolving in the clinical trial process,” he added.

Gottlieb’s statements come on the heels of more activity by a busy FDA. In a new report, the agency says it has processed nearly 1,500 postmarketing requirement and postmarketing commitment studies and trials. It has reduced the backlog to just under 100.

In a statement accompanying the report, Gottlieb added, “We anticipate that the number of [these studies and trials] in the backlog that aren’t yet fully completed will continue to diminish each year as applicants finish studies/trials and submit final reports.”

Author: Michael Causey