Considerations and Approaches for Obese Patient Populations in Drug Development Studies

Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients.

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day virtual public workshop entitled “Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches” on November 9, 2022. The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition.

Besides the major health and socioeconomic implications of obesity, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug pharmacokinetics in obese pediatric patients, the relationship between pediatric obesity and drug response, including efficacy and safety, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to the conduct of such studies and potential innovative solutions to improve data generation and analysis.

The workshop aims to:

• Review the implications of obesity in adult and pediatric patients on safety, efficacy, drug dosing and disposition.
• Discuss whether adult and pediatric patients should be identified and studied as a special population in new drug development programs
• Address when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients

The workshop which is jointly sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA, will be open to the public.

Please visit the FDA’s Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches event page for more information.