Kim Edward S, Uldrick Thomas S, Schenkel Caroline, Bruinooge Suanna S, Harvey R Donald, Magnuson Allison, Spira Alexander, Wade James L, Stewart Mark D, Vega Diana Merino, Beaver Julia A, Denicoff Andrea M, Ison Gwynn, Ivy S Percy, George Suzanne, Perez Raymond P, Spears Patricia A, Tap William D, Schilsky Richard L
City of Hope Orange County and National Medical Center, Los Angeles, California.
Fred Hutchinson Cancer Research Center, Seattle, Washington.
Clin Cancer Res. 2021 May 1;27(9):2394-2399. doi: 10.1158/1078-0432.CCR-20-3852. Epub 2021 Feb 9.
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 () convened working groups to produce additional recommendations and analyze the potential impact on clinical trials using real-world data.
Multistakeholder working groups were appointed by an ASCO- 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.
The four working groups, ASCO Board of Directors, and 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.
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..
限制性临床试验入选标准（EC）限制了能够入组并可能从方案驱动的试验性治疗计划中获益的患者数量，并降低了试验结果对更广泛人群的可推广性。在2017年发布专家利益相关者关于扩大入选标准的建议后，美国临床肿瘤学会（ASCO）和癌症研究之友召集了工作组，以提出更多建议并使用真实世界数据分析对临床试验的潜在影响。
ASCO领导小组任命了多利益相关者工作组，以提出关于更具包容性的入选标准的建议，这些标准涉及：洗脱期、伴随用药、既往治疗、实验室参考范围和检测间隔以及体能状态。
四个工作组、ASCO董事会和领导层支持本声明中包含的建议，以使与洗脱期、伴随用药、既往治疗、实验室参考范围和检测间隔以及体能状态相关的入选标准现代化，从而使试验人群更具包容性，并能代表癌症患者群体。
实施这些建议旨在使确定患者入选资格更加容易。增加患者参与研究的机会将有助于解决某些群体在临床试验中长期代表性不足的问题，并产生对更广泛患者群体更具参考价值的证据。更多符合条件的患者也可能加快临床试验的入组速度。
