Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey
Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey
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DOI：
10.1200/op.20.00275
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发表时间：
2020-07-01
影响因子：
4
通讯作者：
Schilsky, Richard L.
中科院分区：
文献类型：
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作者：
Waterhouse, David M.;Harvey, R. Donald;Schilsky, Richard L.
2019冠状病毒病（COVID-19）大流行扰乱了临床护理的各个方面，包括癌症临床试验。2020年3月，ASCO对其癌症研究委员会和研究社区论坛指导小组及工作组的临床项目进行了调查，以了解临床试验项目在大流行早期所经历的变化和挑战。共有32名受访者; 14名代表学术课程，18名代表社区课程。受访者表示，COVID-19正在导致停止或优先考虑某些临床试验的筛查和/或入组，并停止仅研究访问。大多数受访者报告在可能的情况下进行远程患者护理，并与申办者和/或合同研究组织（CRO）进行远程访问和监测;受访者积极看待这一转变。报告了开展临床试验的许多挑战，包括患者访视减少、人员配置限制和辅助服务有限的情况下的入组和方案依从性困难。与申办者和CRO就修改试验程序进行互动也具有挑战性。调查发现的临床试验程序的变化可以作为其他项目在COVID-19大流行期间试图维持其临床试验组合的策略。此外，在大流行期间对试验进行的许多调整为改善和改造临床试验系统提供了长期机会。具体的改进可以扩大使用更务实或简化的试验设计，减少临床试验相关的患者访视，并尽量减少申办者和CRO对试验项目的访问。
The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic. There were 32 survey respondents; 14 represented academic programs, and 18 represented community-based programs. Respondents indicated that COVID-19 is leading programs to halt or prioritize screening and/or enrollment for certain clinical trials and cease research-only visits. Most reported conducting remote patient care where possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs); respondents viewed this shift positively. Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services. Interactions with sponsors and CROs about modifying trial procedures were also challenging. The changes in clinical trial procedures identified by the survey could serve as strategies for other programs attempting to maintain their clinical trial portfolios during the COVID-19 pandemic. Additionally, many of the adaptations to trials made during the pandemic provide a long-term opportunity to improve and transform the clinical trial system. Specific improvements could be expanded use of more pragmatic or streamlined trial designs, fewer clinical trial-related patient visits, and minimized sponsor and CRO visits to trial programs.