优化早期临床试验冲洗期:儿童白血病和淋巴瘤治疗进展(TACL)联盟报告。

IF 9.9 1区 医学 Q1 ONCOLOGY
Eric S Schafer, Teresa Rushing, Kristine R Crews, Colleen Annesley, Susan I Colace, Nicole Kaiser, Lauren Pommert, Laura B Ramsey, Himalee S Sabnis, Kenneth Wong, Bill H Chang, Todd M Cooper, Nirali N Shah, Susan R Rheingold, Andrew E Place, Yueh-Yun Chi, Deepa Bhojwani, Alan S Wayne, M Brooke Bernhardt
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引用次数: 0

摘要

目的:美国国家癌症研究所(NCI)于 2021 年发布了一份备忘录,采纳了美国临床肿瘤学会(ASCO)和癌症研究之友(Friends of Cancer Research)特别工作组关于扩大临床研究资格标准的建议。他们建议取消大多数既往癌症治疗的冲洗期,并在需要时采用基于证据/合理性的标准。儿童白血病和淋巴瘤治疗进展(TACL)联盟对此指导做出了回应:TACL 工作组审查了联盟的研究组合、相关文献以及 ASCO-Friends、NCI 和美国食品药品管理局 (FDA) 的指导文件,就 TACL 研究冲洗期的现代化、扩大和编纂提出了专家共识和循证建议,同时确保与儿科伦理和联邦法规保持一致。对 TACL 筛选日志进行了审查,以估计更新冲洗期对患者包容性和招募的影响:在 19 年的时间里,有 42 名患者(占所有筛选出的不合格患者(n = 287)的 14.6%)被确定为完全由于不符合冲洗标准而被排除在 TACL 早期阶段研究之外。另有六名患者(2.1%)不符合冲洗标准和至少一项其他排除标准。制定/通过了新的 TACL 剔除指导文件,以供使用。在未取消冲洗标准的情况下,制定了合理/基于证据的标准,并进行了引用:为了减少临床试验中不必要的排斥,TACL主要根据NCI/ASCO-Friends建议的指导,制定了基于合理/证据的冲洗期标准。这些新的、扩展的资格标准有望增加 TACL 临床试验的可及性,同时保持安全性和科学性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimizing early phase clinical trial washout periods: a report from the Therapeutic Advances in Childhood Leukemia and Lymphoma consortium.

Background: 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- and/or rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance.

Methods: 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 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.

Results: Over a 19-year period, 42 (14.6% of all screened ineligible patients [n = 287]) patients were identified as excluded from TACL early phase studies exclusively because of not meeting washout criteria. An additional 6 (2.1%) did not meet washout and at least 1 other exclusion criterion. A new TACL washout guidance document was developed and then adopted for use. Where washout criteria were not eliminated, rationale- and/or evidenced-based criteria were established with citation.

Conclusion: In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale- and/or evidenced-based washout period standards largely following guidance from the NCI and ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.

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来源期刊
CiteScore
17.00
自引率
2.90%
发文量
203
审稿时长
4-8 weeks
期刊介绍: The Journal of the National Cancer Institute is a reputable publication that undergoes a peer-review process. It is available in both print (ISSN: 0027-8874) and online (ISSN: 1460-2105) formats, with 12 issues released annually. The journal's primary aim is to disseminate innovative and important discoveries in the field of cancer research, with specific emphasis on clinical, epidemiologic, behavioral, and health outcomes studies. Authors are encouraged to submit reviews, minireviews, and commentaries. The journal ensures that submitted manuscripts undergo a rigorous and expedited review to publish scientifically and medically significant findings in a timely manner.
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