Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Keynote and panel discussion on communicating heterogeneous treatment effects across populations |
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| Authors: | James Heyward Milena Lolic Catherine Spong David Atkins Gene Pennello Ravi Varadhan |
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| Affiliation: | 1. Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA;2. Office of the Center Director, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;3. Department of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas, Texas, USA;4. Health Services Research and Development Service, U.S. Department of Veterans Affairs, Washington, District of Columbia, USA;5. Division of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland, USA;6. Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA |
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| Abstract: | How do we communicate nuanced regulatory information to different audiences, recognizing that the consumer audience is very different from the physician audience? In particular, how do we communicate the heterogeneity of treatment effects - the potential differences in treatment effects based on sex, race, and age? That is a fundamental question at the heart of this panel discussion. Each panelist addressed a specific “challenge question” during their 5-minute presentation, and the list of questions is provided. The presentations were followed by a question and answer session with members of the audience and the panelists. |
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| Keywords: | clinical trials drug trial snapshot subgroup analysis treatment effects |
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