TY - JOUR
T1 - Heterogeneity in treatment effects across diverse populations
AU - Nugent, Bridget M.
AU - Madabushi, Rajanikanth
AU - Buch, Barbara
AU - Peiris, Vasum
AU - Crentsil, Victor
AU - Miller, Virginia M.
AU - Bull, Jonca
AU - R. Jenkins, Marjorie
N1 - Publisher Copyright:
© 2021 John Wiley & Sons Ltd. This article has been contributed to by US Government employees and their work is in the public domain in the USA.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - 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.
AB - 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.
KW - demographic differences
KW - patient diversity
KW - population health
KW - treatment heterogeneity
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U2 - 10.1002/pst.2161
DO - 10.1002/pst.2161
M3 - Article
C2 - 34396690
AN - SCOPUS:85112444720
SN - 1539-1604
VL - 20
SP - 929
EP - 938
JO - Pharmaceutical Statistics
JF - Pharmaceutical Statistics
IS - 5
ER -