FDA Puts Spotlight on Decentralized Clinical Trials

Isaac Rodriguez-Chavez, PhD, MHSc, MSc, FDA Officer, Clinical Research Methodology, Regulatory Compliance and Medical Policy Development

Decentralized clinical trials (DCTs) offer opportunities to optimize efficiencies in clinical trials, a number of U.S. Food and Drug Administration (FDA) officials, including Dr. Isaac R. Rodriguez-Chavez, have said at recent public conferences.

Dr. Rodriguez-Chavez and others believe DCTs will make it more convenient for individuals to participate in trials.

They will help the clinical trial industry do a more thorough job accessing diverse populations by reducing geographical barriers—increasing enrollment and retention of trial participants—and bringing trials to the local environments where trial participants reside, thus expediting trial conduct and hopefully decreasing costs.

Advocates of DCTs also hope leveraging them with local healthcare providers and digital health technologies will accelerate medical product development and speed delivery of therapies to patients.

FDA is following the regulatory framework approved by Congress regarding the 21st Century Cures Act and the modernization of clinical research while protecting public health.

Meantime, FDA recognizes the need to guide the clinical research field at large about DCTs, and its Center for Drug Evaluation and Research recently announced plans to release a guidance in 2020.

Author: Michael Causey