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大流行期间的临床证据生成:持续进展的经验教训。

Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress.

机构信息

From the Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD.

Medical Oncology, Bristol Myers Squibb.

出版信息

Cancer J. 2022;28(2):151-156. doi: 10.1097/PPO.0000000000000589.

Abstract

Because of significant adaptations forced by the COVID-19 pandemic, resultant changes within health care delivery and clinical research introduced the potential for evaluation of novel evidence generation approaches in oncology. On July 26 and 27, 2021, the National Academies of Science, Engineering, and Medicine, National Cancer Policy Forum hosted a virtual workshop entitled "Cancer Care and Cancer Research in the Context of the COVID-19 Pandemic: A Workshop on Lessons Learned." This workshop examined changes in cancer care and cancer research that occurred in response to the COVID-19 pandemic and considered lessons learned from that experience. The goal was to identify what changes could improve the delivery of high-quality cancer care and the conduct of cancer clinical trials in the postpandemic era, with an emphasis on health equity. How can we sustain the valuable lessons learned that might accelerate progress and enhance clinical evidence generation for patients and clinicians? In this overview, we discuss ways in which the COVID-19 experience has catalyzed research efficiencies as well as fostered a broader array of trial design and research methods that may facilitate improved cancer drug development during the pandemic and beyond.

摘要

由于 COVID-19 大流行带来的重大适应变化,医疗保健服务和临床研究的相应变化带来了评估肿瘤学新证据生成方法的潜力。2021 年 7 月 26 日和 27 日,美国国家科学院、工程院和医学研究院、国家癌症政策论坛主办了一次题为“COVID-19 大流行背景下的癌症护理和癌症研究:经验教训研讨会”的虚拟研讨会。本次研讨会考察了应对 COVID-19 大流行而发生的癌症护理和癌症研究的变化,并考虑了从中吸取的经验教训。目标是确定哪些变化可以改善高质量癌症护理的提供和癌症临床试验的开展在后大流行时代,重点是公平健康。我们如何能够保持可能加速进展和为患者和临床医生提供更多临床证据的宝贵经验?在这篇综述中,我们讨论了 COVID-19 经验如何促进研究效率,以及促进更广泛的试验设计和研究方法,这些方法可能有助于在大流行期间及以后改善癌症药物的开发。

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