WASHINGTON, D.C. (May 2, 2023) – The Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President, Science and Regulatory Advocacy Lucy Vereshchagina, PhD, released the following statement on the U.S. Food and Drug Administration’s (FDA)’s release of the draft guidance on decentralized clinical trials:

“Decentralized clinical trials (DCTs) are an important tool that can help improve patient access to clinical trials, increase diverse participation by historically underserved communities and help enhance trial conduct efficiencies. For example, DCTs can help remove logistical barriers to clinical trial participation like travel, time or financial challenges and, through the use of digital health technologies (DHTs), can enable remote data acquisition and patient monitoring.

“While we review this draft guidance, the regulatory environment is adapting to better support DCTs and DHTs, and we appreciate the FDA’s efforts to advance their use in biopharmaceutical development as part of the recently reauthorized Prescription Drug User Fee Act and provisions within the Food and Drug Omnibus Reform Act.”

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $1.1 trillion in the search for new treatments and cures, including $102.3 billion in 2021 alone.

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