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The Importance of Quality Assurance in Radiation Oncology Clinical Trials
Seminars in Radiation Oncology ( IF 3.5 ) Pub Date : 2023-09-06 , DOI: 10.1016/j.semradonc.2023.06.005
Thomas J FitzGerald 1 , Maryann Bishop-Jodoin 2 , Fran Laurie 2 , Matthew Iandoli 2 , Koren Smith 2 , Kenneth Ulin 2 , Linda Ding 2 , Janaki Moni 2 , M Giulia Cicchetti 2 , Michael Knopp 3 , Stephen Kry 4 , Ying Xiao 5 , Mark Rosen 5 , Fred Prior 6 , Joel Saltz 7 , Jeff Michalski 8
Affiliation  

Clinical trials have been the center of progress in modern medicine. In oncology, we are fortunate to have a structure in place through the National Clinical Trials Network (NCTN). The NCTN provides the infrastructure and a forum for scientific discussion to develop clinical concepts for trial design. The NCTN also provides a network group structure to administer trials for successful trial management and outcome analyses. There are many important aspects to trial design and conduct. Modern trials need to ensure appropriate trial conduct and secure data management processes. Of equal importance is the quality assurance of a clinical trial. If progress is to be made in oncology clinical medicine, investigators and patient care providers of service need to feel secure that trial data is complete, accurate, and well-controlled in order to be confident in trial analysis and move trial outcome results into daily practice. As our technology has matured, so has our need to apply technology in a uniform manner for appropriate interpretation of trial outcomes. In this article, we review the importance of quality assurance in clinical trials involving radiation therapy. We will include important aspects of institution and investigator credentialing for participation as well as ongoing processes to ensure that each trial is being managed in a compliant manner. We will provide examples of the importance of complete datasets to ensure study interpretation. We will describe how successful strategies for quality assurance in the past will support new initiatives moving forward.



中文翻译:

质量保证在放射肿瘤学临床试验中的重要性

临床试验一直是现代医学进步的中心。在肿瘤学方面,我们很幸运能够通过国家临床试验网络 (NCTN) 建立适当的结构。NCTN 为科学讨论提供基础设施和论坛,以开发试验设计的临床概念。NCTN 还提供了一个网络组结构来管理试验,以实现成功的试验管理和结果分析。试验设计和实施有许多重要方面。现代试验需要确保适当的试验进行和安全的数据管理流程。同样重要的是临床试验的质量保证。如果要在肿瘤临床医学方面取得进展,研究人员和患者护理服务提供者需要对试验数据的完整、准确和良好控制感到放心,以便对试验分析充满信心,并将试验结果转化为日常实践。随着我们的技术已经成熟,我们需要以统一的方式应用技术来适当解释试验结果。在本文中,我们回顾了涉及放射治疗的临床试验中质量保证的重要性。我们将包括参与机构和研究者资格认证的重要方面以及持续的流程,以确保每项试验都以合规的方式进行管理。我们将提供完整数据集对于确保研究解释的重要性的示例。我们将描述过去成功的质量保证策略将如何支持未来的新举措。

更新日期:2023-09-07
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