The World of Clinical Trial Development Post COVID-19: Lessons Learned from a Global Pandemic

The World of Clinical Trial Development Post COVID-19: Lessons Learned from a Global Pandemic
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DOI:
10.1158/1078-0432.ccr-20-1914
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发表时间:
2020-08-15
影响因子:
11.5
通讯作者:
Dahut, William L.
Dahut, William L.
中科院分区:
医学1区
文献类型:
--
作者:
Karzai, Fatima;Madan, Ravi A.;Dahut, William L.

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2019年新型冠状病毒病(COVID-19)由严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)引起,是一种全球健康威胁(1)。癌症患者是最脆弱的人群之一。在这场大流行期间,NCI研究的临床试验应计费用急剧下降。调查人员迅速转向监管机构,以简化治疗计划,促进远程医疗,并减少所需的数据收集。展望未来,肿瘤学研究界必须利用吸取的经验教训,专注于重新设计研究,以确保关键的科学问题得到安全的回答,同时扩大访问并增加与社区医生的合作伙伴关系。这些变化将加速临床进展,同时保护我们的患者。
The novel coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global health threat (1). Patients with cancer are one of the most vulnerable populations. During this pandemic, clinical trial accrual to NCI studies has fallen dramatically. Investigators quickly turned to regulatory bodies to simplify treatment schedules, facilitate telemedicine, and decrease required data collection. Going forward, the oncology research community must use the lessons learned to focus on redesigning studies to ensure that critical scientific questions are answered safely while expanding access and increasing partnerships with community physicians. These changes will accelerate clinical progress while protecting our patients.