Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group.
Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group.
复制标题
DOI：
10.1158/1078-0432.ccr-20-3853
复制
发表时间：
2021-05-01
期刊：
影响因子：
--
通讯作者：
Gerber DE
中科院分区：
文献类型：
--
作者：
Spira AI;Stewart MD;Jones S;Chang E;Fielding A;Richie N;Wood LS;Thompson MA;Jones L;Nair A;Mahal BA;Gerber DE
在临床研究中，资格标准促进了患者安全并优化了临床试验产生的证据。然而，过于严格的资格标准（包括实验室要求）可能会限制入组，导致试验完成延迟，并可能限制试验结果对全科人群的适用性。从2018年开始，一个由直接患者护理专家、美国食品药品监督管理局（FDA）、行业和患者倡导者组成的工作组制定了建议，以指导临床试验合格标准和研究程序中实验室参考范围和检测间隔的最佳使用。工作组评价了不同临床试验阶段的当前合格性标准，并进行了文献综述，以评价临床试验中实验室检查合格性要求和检测间隔的影响和依据。基于促进安全性和优化所产生证据的目标制定了建议，同时还扩大了合格性和适用性，并最大限度地减少了试验参与的额外负担。总体而言，我们发现实验室检查要求随时间和试验阶段的变化很小，这表明这些合格性标准并未根据正在进行的临床经验进行改进。我们建议在考虑合格标准时优化实验室检查的使用。定制实验室检查要求和检测间隔的使用可能会增加临床试验中患者的数量和多样性，并提供更能代表全科人群的临床数据。
In clinical research, eligibility criteria promote patient safety and optimize the evidence generated from clinical trials. However, overly stringent eligibility criteria—including laboratory requirements—may limit enrollment, resulting in delayed trial completion and potentially limiting applicability of trial results to a general practice population. Starting in 2018, a working group consisting of experts in direct patient care, the U.S. Food and Drug Administration (FDA), industry, and patient advocacy developed recommendations to guide the optimal use of laboratory reference ranges and testing intervals in clinical trial eligibility criteria and study procedures. The working group evaluated current eligibility criteria across different clinical trial phases and performed a literature review to evaluate the impact of and justification for laboratory test eligibility requirements and testing intervals in clinical trials. Recommendations were developed based on the goals of promoting safety and optimizing the evidence generated, while also expanding eligibility and applicability, and minimizing excess burden of trial participation. In general, we found little variation over time and trial phase in laboratory test requirements, suggesting that these eligibility criteria are not refined according to ongoing clinical experience. We propose recommendations to optimize the use of laboratory tests when considering eligibility criteria. Tailoring the use of laboratory test requirements and testing intervals may increase the number and diversity of patients in clinical trials and provide clinical data that more closely represents the general practice populations.