Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group

• Type of Material: Article
• Authors: R. Harvey, Emory University; Kathryn F Mileham, Atrium Health, Charlotte; Vishal Bhatnagar, U.S. Food and Drug Administration, Washington; Jamie R Brewer, U.S. Food and Drug Administration, Washington; Atiqur Rahman, U.S. Food and Drug Administration, Washington; Cassadie Moravek, Pancreatic Cancer Action Network; Andrew S Kennedy, Sarah Cannon Research Institute; Elizabeth A Ness, National Cancer Institute Center for Cancer Research, Bethesda; Claire E Dees, UNC Lineberger Comprehensive Cancer Center; Percy S Ivy, National Cancer Institute Cancer Therapy Evaluation Program, Bethesda; Scot W Ebbinghaus, Merck & Co., North Wales; Caroline Schenkel, American Society of Clinical Oncology; Thomas S Uldrick, Fred Hutchinson Cancer Research Center, Seattle
• Language: English
• Date: 2021-05-01
• Publisher: AMER ASSOC CANCER RESEARCH
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2021, American Association for Cancer Research
• Final Published Version (URL): http://dx.doi.org/10.1158/1078-0432.CCR-20-3855
• Title of Journal or Parent Work: CLINICAL CANCER RESEARCH
• Volume: 27
• Issue: 9
• Start Page: 2400
• End Page: 2407
• Keywords: ENZYMES; ADVERSE EVENTS; ACQUIRED-RESISTANCE; ERLOTINIB; Science & Technology; Oncology; GEFITINIB; DISCONTINUATION; AGENTS; Life Sciences & Biomedicine; POLYPHARMACY; TYROSINE KINASE INHIBITOR

Abstract

Purpose: Washout periods and concomitant medication exclusions are common in cancer clinical trial protocols. These exclusion criteria are often applied inconsistently and without evidence to justify their use. The authors sought to determine how washout period and concomitant medication allowances can be broadened to speed trial enrollment and improve the generalizability of trial data to a larger oncology practice population without compromising the safety of trial participants. Experimental Design: A multistakeholder working group was convened to define problems associated with excessively long washout periods and exclusion of patients due to concomitant medications. The group performed a literature search and evaluated study data from the Pancreatic Cancer Action Network (PanCAN), Emory University School of Medicine (Atlanta, GA), and the FDA to understand recent approaches to these eligibility criteria. The group convened to develop consensus recommendations for broadened eligibility criteria. Results: The data analysis found that exclusion criteria based on washout periods and concomitant medications are frequently inconsistent and lack scientific rationale. Scientific rationale for appropriate eligibility criteria are presented in the article; for washout periods, rationale is presented by treatment type. Conclusions: Arbitrary or blanket washout and concomitant medication exclusions should be eliminated. Where there is evidence to support them, clinically relevant washout periods and concomitant medication–related eligibility criteria may be included. See related commentary by Giantonio, p. 2369