ACCP Position Statement: "Inclusion of Obese Participants in Drug Development: Reflections on the Current Landscape and a Call for Action"

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American College of Clinical Pharmacology

Jan 11, 2024, 11:02 ET

ASHBURN, Va., Jan. 11, 2024 /PRNewswire/ -- A recent Position Paper from the American College of Clinical Pharmacology^® (ACCP) entitled "Inclusion of Obese Participants in Drug Development: Reflections on the Current Landscape and a Call for Action" was published in The Journal of Clinical Pharmacology. Obesity is a national health issue, with a prevalence that has increased steadily in the United States over the past 20 years. This is a concern, as obesity is associated with an increased risk for many other comorbid diseases. This Position Paper calls for actions to enable the inclusion of obese participants in clinical trials during the drug development process. Inclusion of obese participants in clinical trials during drug development should be considered and discussed among clinicians, sponsors and regulators in the context of the prevalence of obesity and related comorbidities in the target patient population. Potential impact of obesity on the clinical pharmacology of drugs, current dosing paradigms in obese patients, clinical pharmacology tools to evaluate impact of obesity on dosing, and regulatory considerations are discussed in the paper. A road map is proposed for the inclusion of obese participants within clinical trials and evidence synthesis through model-informed data integration to optimize the posology of therapeutics and maximize benefit versus risk in the intended patient population.

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SOURCE American College of Clinical Pharmacology