美国国家癌症研究所 (NCI) 发布了 2021 年备忘录，采纳美国临床肿瘤学会 (ASCO) 和癌症研究之友 (Friends) 工作组的建议，以扩大临床研究资格标准。他们建议取消大多数先前癌症治疗的清除期，并在需要时利用基于证据/理由的标准。儿童白血病和淋巴瘤治疗进展 (TACL) 联盟对此指南做出了回应。TACL 工作组审查了该联盟的研究组合、ASCO-Friends、NCI 和美国食品和药物管理局 (FDA) 的相关文献和指导文件，以制定专家共识和基于证据的建议，以现代化、扩大和规范 TACL 研究清除期，同时确保符合儿科伦理和联邦法规。 TACL 的筛查日志经过审查，以估计更新的清除期对患者包容性和招募的影响。在 19 年期间，42 名患者（所有筛查不合格 (n = 287) 患者的 14.6%）被确定为排除在外TACL 早期研究完全是由于不符合洗脱标准。另外六个 (2.1%) 不符合清除标准和至少一项其他排除标准。制定/采用了新的 TACL 清洗指导文件。在未消除洗脱标准的情况下，建立了基于理由/基于证据的标准并引用。为了减少临床试验中不必要的排除，TACL 主要遵循 NCI/ASCO-Friends 建议的指导，制定了基于理由/基于证据的洗脱期标准。这些新的、扩大的资格标准预计将增加 TACL 临床试验的机会，同时保持安全性和科学卓越性。© 作者 2024。由牛津大学出版社出版。版权所有。如需权限，请发送电子邮件至：journals.permissions@oup.com。

The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required, to utilize evidence/rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance.A TACL task force reviewed the consortium's research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration (FDA) to make expert consensus and evidence-based recommendations for modernizing, broadening and codifying TACL-study washout periods while ensuring consistency with pediatric ethics and federal regulations. TACL's screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment.Over a 19-year period, 42 patients (14.6% of all screened ineligible (n = 287) patients), were identified as excluded from TACL early-phase studies exclusively due to not meeting washout criteria. An additional six (2.1%) did not meet washout and at least one other exclusion criterion. A new TACL washout guidance document was developed/adopted for use. Where washout criteria were not eliminated, rationale/evidenced-based criteria were established with citation.In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale/evidenced-based washout period standards largely following guidance from the NCI/ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.