The FDA wants to modernize clinical trials

Clinical trials could soon get a modern update, thanks to new Food and Drug Administration (FDA) draft recommendations that aim to make the process more efficient and encourage the use of digital health technologies.

FDA officials on Tuesday announced updated guidance that builds on recent International Council for Harmonisation proposals, which were developed to help incorporate new technological and methodological advances into clinical trials. Critics have argued that the clinical trial process has become expensive, outdated, and inefficient—challenges that were only highlighted during the Covid-19 pandemic.

FDA Commissioner Robert Califf said the proposals—which, among other things, promote using digital health technologies, like wearable sensors, to help with data collection and patient recruitment—mark “a major step forward” in the agency’s efforts to create “a more robust clinical trial ecosystem.”

“Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results,” he said in a statement.

Khair ElZarrad, director of the FDA Center for Drug Evaluation and Research’s Office of Medical Policy, added that the proposals aim to “streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve.”

The public has 60 days to weigh in on the draft recommendations. Once finalized, they will update existing “good clinical practice” guidance.

The latest proposals come just weeks after the agency released draft guidance on decentralized clinical trials.