Patient-Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019

Vishal Bhatnagar; Stacie Hudgens; Elisabeth Piault-Louis; Lee Jones; Julia A Beaver; H Kim Lyerly; Gregory Reaman; Thomas Fleming; Paul G Kluetz

doi:10.1634/theoncologist.2020-0062

Patient-Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019

Oncologist. 2020 Oct;25(10):819-821. doi: 10.1634/theoncologist.2020-0062. Epub 2020 Jun 9.

Authors

Vishal Bhatnagar¹, Stacie Hudgens², Elisabeth Piault-Louis³, Lee Jones⁴, Julia A Beaver⁵, H Kim Lyerly⁶, Gregory Reaman¹, Thomas Fleming⁷, Paul G Kluetz¹

Affiliations

¹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Quantitative Science, Clinical Outcomes Solutions, Tucson, Arizona, USA.
³ Genentech, Inc., South San Francisco, California, USA.
⁴ Patient Representative, Arlington, Virginia, USA.
⁵ Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁶ Duke University, Durham, North Carolina, USA.
⁷ Department of Biostatistics, University of Washington, Seattle, Washington, USA.

Abstract

The measurement and analysis of patient‐reported outcomes is important in cancer clinical trials. This commentary reports advances and challenges from presentations at the 2019 Accelerating Anticancer Agent Development and Validation (AAADV) Workshop Patient‐Reported Outcomes Session.

Keywords: Clinical trials; Patient-reported outcome measures.

MeSH terms

Antineoplastic Agents* / therapeutic use
Humans
Medical Oncology*
Patient Reported Outcome Measures

Substances

Antineoplastic Agents