FDA Reassurances Always Go a Long Way

Lisa Henderson, Editor-in-Chief

For many years, it’s been discussed that FDA is a barrier to change…mostly related to a change in process or a change of technology. Though regulators would routinely come forward to reassure the industry that their guidance documents supported change, fear and insecurities still abound. It does take time to change, but the FDA really does support advances in clinical trials. But every so often, it is reassuring to hear it in the agency’s own words, especially now with talks of decentralized trials and patient participation. Recently, FDA has been asked about ongoing changes in clinical trials from the point of decentralization and participation.

Last month, Amy Abernethy, MD, PhD, principal deputy commissioner and interim CIO for the FDA, gave the opening keynote for the Veeva Systems R&D and Quality Summit. As a hematologist/oncologist and palliative medicine physician, and internationally recognized clinical data expert and clinical researcher, she shared her compelling views on those discussions. She set the stage by saying the practical reality of clinical trials features two important responsibilities, (1) keep study participants safe and (2) generate a high-quality data set that will answer the question at hand.

For that, Abernethy stressed that the “site is critical to that entire set of activities.” And specifically for decentralized clinical trials, she said: “I think about a series of solutions that help physicians or other healthcare providers involved in the clinical trial process and keep patients safe. It also allows us to be able to have, even if it’s virtual, eyes on the person receiving care to make sure that we know how the patient is doing.”

Abernethy continued, “I think that from the perspective of the site investigator involved in decentralized clinical trials, they still are going to continue to have this incredibly important central function—even if it’s a decentralized clinical trial—of continuing to lead that focus of patient safety, and then also contributing to the clinical trial in alliance with the study protocol.”

At a closed event, a member of FDA declared that “Participating in clinical trials is an imposition on people. If we can move to trial designs that are more pragmatic, with less burden and allows for more participation…” that would be a plus.

There was also the hint that the speed with which FDA issued guidances in the early pandemic could become the norm; the process would shorten to release with a more fluid approach to alterations or changes as needed.

The FDA is moving with the times, and with speed. It will be up to some in the industry to respond in kind.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com.