Fred Hutchinson Cancer Center, Seattle, WA.
Friends of Cancer Research, Washington, DC.
JCO Oncol Pract. 2023 Oct;19(10):907-916. doi: 10.1200/OP.23.00185. Epub 2023 Aug 29.
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.
COVID-19 大流行的爆发对癌症临床研究的开展造成了重大干扰。为此，监管机构和赞助商允许对传统试验流程进行修改，以确保临床研究和护理工作能够继续进行。我们系统地评估了这些缓解策略如何影响数据质量和整体试验开展。
本研究采用了调查和现场访谈。邀请了 41 个主要的行业和美国国立癌症研究所网络团体（赞助商）参与，这些团体负责监督 2015 年 1 月至 2022 年 5 月期间在美国开展的抗癌治疗试验。调查数据总结采用描述性统计。识别访谈中的关键主题。
20 个赞助商（48.8%；15 个行业和 5 个网络团体）完成了调查；11/20（55.0%）参加了访谈。赞助商主要（n=12；60.0%）报告了大量（≥11 个）二期和/或三期试验的试验组合。报告在初始大流行浪潮中与大流行前相比，方案偏离度中度（9 个）或大幅度（8 个）增加的赞助商比例为 89.5%（17/19）；报告大幅度增加的比例从初始浪潮中的 42.1%（n=19）降至 15.8%（n=3/19）。最常采用的缓解策略是远程分发口服抗癌药物（70.0%）、远程监测不良事件（65.0%）和远程知情同意（65.0%）。大多数受访者（15/18；83.3%）报告称，大流行对整体数据完整性的影响最小（n=14）或没有影响（n=1）。
尽管几乎所有赞助商都观察到方案偏离度的暂时增加，但大多数报告称大流行对整体数据完整性的影响最小/没有。COVID-19 大流行加速了试验开展方面更大灵活性的新兴趋势，潜在地减轻了试验参与者和试验点的负担，并提高了患者获得研究的机会。
