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揭开放射肿瘤学临床试验对于方案科学审查人员及机构审查委员会成员的相关问题的神秘面纱。

Demystifying radiation oncology clinical trial concerns for protocol scientific review and institutional review board committee members.

作者信息

Qazi Jamiluddin, DeHaai Kristi A, Hawkins Benjamin M, Romano Kara D, Zaorsky Nicholas G, Chen Ronald C, Showalter Timothy N

机构信息

Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, VA, USA.

Institutional Review Board for Health Sciences Research, University of Nebraska Medical Center, Omaha, NE, USA.

出版信息

Contemp Clin Trials Commun. 2022 Mar 19;27:100911. doi: 10.1016/j.conctc.2022.100911. eCollection 2022 Jun.

Abstract

Clinical trials are essential for evaluating advanced technologies and treatment approaches involving radiation therapy to improve outcomes for cancer patients. Clinical trials at cancer centers with designation from the National Cancer Institute must undergo scientific review in additional to Institutional Review Board approval. Given the highly specialized nature and rapidly advancing technologies of radiation therapy, and the small number of radiation oncology investigators at some centers, a lack of radiation oncology expertise among reviewers may present challenges at some cancer centers. This commentary aims to provide an overview of radiation therapy and special considerations for radiation oncology research that will serve as a helpful resource in the scientific review of clinical trials involving cancer patients.

摘要

临床试验对于评估涉及放射治疗的先进技术和治疗方法以改善癌症患者的治疗效果至关重要。获得美国国立癌症研究所指定的癌症中心进行的临床试验,除了需经机构审查委员会批准外,还必须接受科学审查。鉴于放射治疗的高度专业性、技术的快速发展,以及一些中心放射肿瘤学研究人员数量较少,审查人员中缺乏放射肿瘤学专业知识可能会给一些癌症中心带来挑战。本评论旨在概述放射治疗以及放射肿瘤学研究的特殊注意事项,这将为涉及癌症患者的临床试验科学审查提供有益的参考资源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a36d/8956792/eb6f30acee42/gr1.jpg

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