Premium
Heterogeneity in treatment effects across diverse populations
Author(s) -
Nugent Bridget M.,
Madabushi Rajanikanth,
Buch Barbara,
Peiris Vasum,
Crentsil Victor,
Miller Virginia M.,
Bull Jonca,
Jenkins Marjorie
Publication year - 2021
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.2161
Subject(s) - medicine , center of excellence , food and drug administration , safer , clinical trial , race (biology) , demographics , population , excellence , intensive care medicine , pharmacology , environmental health , demography , biology , pathology , botany , computer security , sociology , political science , computer science , law
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.