TY - JOUR
T1 - Continuing to broaden eligibility criteria to make clinical trials more representative and inclusive
T2 - ASCO-Friends of Cancer Research Joint Research Statement
AU - Kim, Edward S.
AU - Uldrick, Thomas S.
AU - Schenkel, Caroline
AU - Bruinooge, Suanna S.
AU - Harvey, R. Donald
AU - Magnuson, Allison
AU - Spira, Alexander
AU - Wade, James L.
AU - Stewart, Mark D.
AU - Vega, Diana Merino
AU - Beaver, Julia A.
AU - Denicoff, Andrea M.
AU - Ison, Gwynn
AU - Ivy, S. Percy
AU - George, Suzanne
AU - Perez, Raymond P.
AU - Spears, Patricia A.
AU - Tap, William D.
AU - Schilsky, Richard L.
N1 - Funding Information:
E.S. Kim reports personal fees from AstraZeneca, Boehringer Ingelheim, and Genentech outside the submitted work. T.S. Uldrick reports other from Merck, Roche, and Celgene/BMS outside the submitted work; in addition, T.S. Uldrick has a patent for U.S. 10,001,483 B2 issued to Celgene and NCI. A. Magnuson reports National Institute on Aging K76 Career Development Award, NCI Loan Repayment Award, and honoraria for an educational lecture provided at the American Society of Radiation Oncology 2020 annual meeting. D.M. Vega reports nonfinancial support from Aetion outside the submitted work. S. George reports personal fees and other from Blueprint Medicines, Deciphera Pharmaceuticals, and Bayer; other from Daiichi Sankyo, Wolter Kluwer, Pfizer, and Novartis; and personal fees from Eli Lilly, NCCN, ResearchToPractice, OncLive, and Medscape outside the submitted work; Dr. George is vice-chair of Alliance for Clinical Trials in Oncology and vice-president, Alliance Foundation. P.A. Spears reports personal fees from Pfizer, Inc outside the submitted work. W.D. Tap reports personal fees from Eisai, Eli Lilly, GlaxoSmithKline, EMD Serono, Nanocarrier, Blueprint, Daiichi, Agios, and Deciphera outside the submitted work. In addition, W.D. Tap has a patent for Companion Diagnostic for CDK4 inhibitors - 14/854,329 pending to MSKCC/SKI, reports scientific advisory board membership with Certis Oncology Solutions (stock ownership), and is co-founder of Atropos Therapeutics (stock ownership). R.L. Schilsky reports grants from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Lilly, Merck, and Pfizer outside the submitted work. No disclosures were reported by the other others.
Publisher Copyright:
© 2021 American Association for Cancer Research.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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.
AB - 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.
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U2 - 10.1158/1078-0432.CCR-20-3852
DO - 10.1158/1078-0432.CCR-20-3852
M3 - Review article
C2 - 33563632
AN - SCOPUS:85105240171
VL - 27
SP - 2394
EP - 2399
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 9
ER -