The increase in the complexity of cancer clinical trials over the past several decades has led to a dramatic growth in trial cost and operational burden. The extent and frequency of data collection, particularly in late phase trials which enroll many participants, have been major contributors to this problem. The Clinical Trials and Translational Research Advisory Committee of the National Cancer Institute (NCI) recently assessed the impact of these stressors on the NCI National Clinical Trials Network (NCTN) and recommended that data collection in late phase NCTN trials be limited to data elements essential to address the primary and secondary objectives of the trial. The purpose of this commentary is to describe the rationale for this recommendation, progress towards implementation, and the development of new streamlined standard practices for data collection for late phase NCTN trials effective January 1, 2025.

中文翻译：

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简化癌症临床试验的实施：国家癌症研究所后期临床研究的新标准数据收集实践


过去几十年来，癌症临床试验的复杂性不断增加，导致试验成本和运营负担急剧增加。数据收集的范围和频率，特别是在招募许多参与者的后期试验中，是造成这一问题的主要原因。美国国家癌症研究所 (NCI) 的临床试验和转化研究咨询委员会最近评估了这些压力因素对 NCI 国家临床试验网络 (NCTN) 的影响，并建议后期 NCTN 试验中的数据收集仅限于对以下方面至关重要的数据元素：解决试验的主要和次要目标。本评论的目的是描述该建议的基本原理、实施进展以及为 NCTN 后期试验数据收集制定新的简化标准实践，该实践将于 2025 年 1 月 1 日生效。