Heterogeneity in treatment effects across diverse populations |
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| Authors: | Bridget M Nugent Rajanikanth Madabushi Barbara Buch Vasum Peiris Victor Crentsil Virginia M Miller Jonca Bull Marjorie R Jenkins |
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| Institution: | 1. Office of Women's Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;2. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;3. Center for Biologics Evaluation & Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;4. Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;5. Office of Drug Evaluation III, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;6. Departments of Surgery, and Physiology and Bioengineering, Mayo Clinic, Rochester, Minnesota, USA;7. Global Product Development, PPDi, Wilmington, North Carolina, USA |
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| Abstract: | Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race. The panel discussed the US Food and Drug Administration's role in reviewing and regulating drugs, devices, and biologic products and the challenges associated with ensuring that diverse patient populations benefit from these therapeutics. Ultimately, ensuring diverse demographic inclusion in clinical trials, and designing basic and clinical research studies to account for the intended patient population's age, sex, race, and genetic factors among other characteristics, will lead to better, safer therapies for diverse patient populations. |
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| Keywords: | demographic differences patient diversity population health treatment heterogeneity |
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