@article{263f200e05c14be5a850301ac580e665,
title = "Assessing and communicating heterogeneity of treatment effects for patient subpopulations: Keynote and panel discussion on communicating heterogeneous treatment effects across populations",
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.",
keywords = "clinical trials, drug trial snapshot, subgroup analysis, treatment effects",
author = "James Heyward and Milena Lolic and Catherine Spong and David Atkins and Gene Pennello and Ravi Varadhan",
note = "Funding Information: This work was supported in part by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to Johns Hopkins University from the U.S. Food & Drug Administration U01FD005942. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA. Funding Information: This work was supported in part by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to Johns Hopkins University from the U.S. Food & Drug Administration U01FD005942. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA. Publisher Copyright: {\textcopyright} 2021 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.",
year = "2021",
month = sep,
day = "1",
doi = "10.1002/pst.2123",
language = "English (US)",
volume = "20",
pages = "965--978",
journal = "Pharmaceutical Statistics",
issn = "1539-1604",
publisher = "John Wiley and Sons Ltd",
number = "5",
}