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适应大流行——在 SARS-CoV-2 大流行期间开展肿瘤学试验。

Adapting to a Pandemic - Conducting Oncology Trials during the SARS-CoV-2 Pandemic.

机构信息

Division of Medical Oncology, National Cancer Centre Singapore, Singapore.

Duke University Medical Center, Duke University, Durham, North Carolina.

出版信息

Clin Cancer Res. 2020 Jul 1;26(13):3100-3103. doi: 10.1158/1078-0432.CCR-20-1364. Epub 2020 Apr 20.

Abstract

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has necessitated changes in cancer care delivery as resources are reallocated. Clinical trials and other research activities are inevitably impacted. Start-up activities for new trials may be deferred and recruitment suspended. For patients already enrolled however, there are challenges in continuing treatment on trial. Regulatory bodies have issued guidance on managing clinical trials during the pandemic, including contingency measures for remote study visits, delivery of investigational product, and site monitoring visits. New cancer clinical trial practices during the SARS-CoV-2 pandemic include new risk assessment strategies, decentralized and remote trial coordination, data collection, and delegation of specific therapeutic activities. This experience could provide evidence of more feasible and cost-effective methods for future clinical trial conduct.

摘要

严重急性呼吸综合征冠状病毒 2 型(SARS-CoV-2)大流行需要重新分配资源,从而改变癌症治疗的方式。临床试验和其他研究活动不可避免地受到影响。新试验的启动活动可能会推迟,招募也会暂停。然而,对于已经入组的患者,在试验中继续治疗存在挑战。监管机构已经发布了关于大流行期间管理临床试验的指南,包括远程研究访视、研究产品交付和现场监测访视的应急措施。SARS-CoV-2 大流行期间的新癌症临床试验实践包括新的风险评估策略、分散和远程试验协调、数据收集以及特定治疗活动的委托。这种经验可能为未来临床试验提供更可行和更具成本效益的方法的证据。

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