Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Leonard Sacks, MBBCh
Associate Director for Clinical Methodologies
Office of Medical policy (OMP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Leonard Sacks received his medical education in South Africa, moving to the USA in 1987, where he completed fellowships in immunopathology and Infectious Diseases. He worked as an attending physician in Washington DC and South Africa, and he joined the FDA in 1998 as medical reviewer in the Office of New Drugs. Subsequent positions included acting director of the Office of Critical Path Programs and associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. In this capacity he has led efforts to support novel approaches to clinical trials including the use of electronic technology. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented on these topics. He holds academic appointments as Associate Clinical Professor of Medicine at George Washington University, and at the Uniformed Services University of the Health Sciences.
Abstract
Leonard Sacks’s presentation explores innovative approaches to clinical trials, focusing on decentralized and digital strategies to alleviate patient burden and enhance trial efficiency. He explains that technology-enabled trials leverage communication, telemedicine, and biosensors for remote data acquisition. The FDA’s guidance on decentralized elements allows trial activities at convenient locations like patients’ homes or local clinics, improving accessibility for diverse populations, boosting convenience, and providing efficiencies such as reduced travel. Key decentralized strategies include remote trial visits, utilizing local healthcare providers, conducting home visits, and direct investigational product distribution. Sacks also discusses integrating randomized controlled trials into routine clinical practice, where trials are conducted within patients’ normal care settings to accelerate enrollment and reflect real-world effectiveness. Furthermore, he highlights digital health technologies (DHTs) like wearables and interactive applications, which provide rich, continuous data and enable new types of measurements (e.g., continuous glucose monitoring, gait stability). Verification and analytic validation ensure DHT accuracy, though the clinical justification of an endpoint remains independent of the measurement tool. Sacks clarifies that DHTs generally do not require FDA marketing approval unless used as medical devices, with regulatory focus on data quality and integrity. These advancements collectively improve trial efficiencies, patient convenience, and access for diverse participants.