Continuing to broaden eligibility criteria to make clinical trials more representative and inclusive: ASCO-Friends of Cancer Research Joint Research Statement

Edward S. Kim, Thomas S. Uldrick, Caroline Schenkel, Suanna S. Bruinooge, R. Donald Harvey, Allison Magnuson, Alexander Spira, James L. Wade, Mark D. Stewart, Diana Merino Vega, Julia A. Beaver, Andrea M. Denicoff, Gwynn Ison, S. Percy Ivy, Suzanne George, Raymond P. Perez, Patricia A. Spears, William D. Tap, Richard L. Schilsky

Research output: Contribution to journalReview articlepeer-review

Abstract

Purpose: Restrictive clinical trial eligibility criteria (EC) limit the number of patients who can enroll and potentially benefit from protocol-driven, investigational treatment plans and reduce the generalizability of trial results to the broader population. Following publication of expert stakeholder recommendations for broadening EC in 2017, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) convened working groups to produce additional recommendations and analyze the potential impact on clinical trials using real-world data. Experimental Design: Multistakeholder working groups were appointed by an ASCO-Friends leadership group to propose recommendations for more inclusive EC related to: washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and performance status. Results: The four working groups, ASCO Board of Directors, and Friends leadership support the recommendations included in this statement to modernize EC related to washout periods, concomitant medications, prior therapies, laboratory references ranges and test intervals, and performance status to make trial populations more inclusive and representative of cancer patient populations. Conclusions: Implementation of the recommendations is intended to result in greater ease of determining patient eligibility. Increased opportunities for patient participation in research will help address longstanding underrepresentation of certain groups in clinical trials and produce evidence that is more informative for a broader patient population. More patients eligible will also likely speed clinical trial accrual.

Original languageEnglish (US)
Pages (from-to)2394-2399
Number of pages6
JournalClinical Cancer Research
Volume27
Issue number9
DOIs
StatePublished - May 1 2021
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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