FDA Focuses Efforts on DHT

At DIA 2023, members from FDA updated the audience on decentralized clinical trials (DCTs) and their closely-related enabler, digital health technologies (DHTs). Jacqueline Corrigan-Curay, JD, MD, principal deputy center director, the Center for Drug Evaluation and Research (CDER), noted that under PDUFA VII, a DHT steering committee was formed. One goal of the committee is to accelerate DHTs’ move into the larger environment of DCTs. The hope is to bring trials where patients are, connect DHTs to those who are willing to use them, and ensure that their use is not inadvertently excluding a person
or populations.

Corrigan-Curay said further in regard to DCTs, “We need to understand and to pre-plan. You have to think of the appropriate trial for a DCT. What COVID has done is make us think about what can be decentralized. We’ve always had aspects of it, but what’s new are the sophisticated platforms.”

Another aspect of DHTs was brought forward by Hilary Marston, MD, MPH, chief medical officer, FDA. She remarked that DHTs “provide an opportunity to reflect on patient experience outside of the clinic”—but how that is achieved so that the information is accurate from the device and reflects the intervention on outcome progress. She added, “We need to make sure they are accurately reflecting a clinical endpoint of understanding, and that’s challenging.” Marston then noted that to achieve that understanding, drug developers would have to invest in studies to evaluate the risks; since it’s not their core business, it becomes a difficult area to justify the spend, she points out.

A Q&A on FDA’s website with Leonard Sacks, MD, associate director for clinical methodology in CDER’s Office of Medical Policy, stressed the involvement of sponsors in regulatory processes and directed them to resources, as well as an email to aid FDA in addressing DHT-derived data questions. He said, “We are working on electronic methods to track drug application submissions containing DHT-derived data. We are asking sponsors to use the updated versions of FDA forms 1571 and 356h to indicate when they include DHT data in submissions. This will help us understand the changing landscape of DHT utilization, and the trends, challenges, and opportunities for implementation.”

Lisa Henderson is the editor-in-chief of Applied Clinical Trials