COVID-19疫情爆发导致癌症临床试验的进行受到了重大的干扰。为了应对这一情况，监管机构和赞助商允许对传统试验流程进行修改，以便继续进行临床研究和护理。我们对这些缓解策略对数据质量和整体试验进行了系统评估。本研究采用了调查和实时访谈的方法。我们邀请了从2015年1月至2022年5月开放在美国的40个主要行业和国家癌症研究所网络组织（赞助商）监管的抗癌治疗试验。我们对调查数据进行了描述性统计，并从访谈中提取了关键主题。总共有20个赞助商（48.8％；15个行业赞助商和5个网络组织）完成了调查，并有11个赞助商（55.0％）参与了访谈。赞助商主要报告了大型（≥11个试验）的Ⅱ期和/或Ⅲ期试验项目（n = 12; 60.0％）。在最初的疫情波动期与疫情前期相比，报告在试验方案偏差中出现中等（9个）或显著（8个）增加的赞助商比例为89.5％（17/19）。此后，报告显著增加的赞助商比例从42.1％（n = 8/19）下降到15.8％（n = 3/19）。最常采用的缓解策略包括口服抗癌治疗远程分发（70.0％），远程不良事件监测（65.0％）和远程同意书签署（65.0％）。大多数受访者（15/18; 83.3％）表示疫情对整体数据完整性的影响很小（n = 14）或没有影响（n = 1）。尽管几乎所有赞助商都观察到了短期的试验方案偏差增加，但大部分报告称疫情对整体数据完整性的影响很小或没有影响。COVID-19疫情加速了朝着试验进行更加灵活的新趋势发展，并可能降低试验参与者和研究机构的负担，提高患者对研究的接触机会的好处。

The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct.This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified.Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity.Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.