Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities

Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) and U.S. Food and Drug Administration (FDA)
Nov. 28, 2018

FDA WHITE OAK CAMPUS, BLDG. 31
10903 New Hampshire Avenue
Silver Spring, MD 20993

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This symposium is comprised of talks and panel discussions by leading experts that engages various stakeholders in how to assess and communicate heterogeneity of treatment effects (HTE).

The symposium will focus on the following topics:

  • Major sources of HTE including subpopulations (e.g., sex, race, pediatric and geriatric populations)
  • HTE considerations in study design and statistical analysis
  • How HTE may be communicated to stakeholders via various avenues such as drug trial snapshots and labeling.

Posted: Aug. 13, 2018