研究动态
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放射治疗临床试验中质量保证的重要性.

The Importance of Quality Assurance in Radiation Oncology Clinical Trials.

发表日期:2023 Oct
作者: Thomas J FitzGerald, Maryann Bishop-Jodoin, Fran Laurie, Matthew Iandoli, Koren Smith, Kenneth Ulin, Linda Ding, Janaki Moni, M Giulia Cicchetti, Michael Knopp, Stephen Kry, Ying Xiao, Mark Rosen, Fred Prior, Joel Saltz, Jeff Michalski
来源: SEMINARS IN RADIATION ONCOLOGY

摘要:

临床试验已成为现代医学进步的中心。在肿瘤学领域,我们有幸通过国家临床试验网络(NCTN)建立了一个结构。NCTN为临床设计开发临床概念提供了基础设施和科学讨论的论坛。NCTN还提供网络群组结构,以实施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执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。如果肿瘤学临床医学要取得进展,研究者和病患护理提供者需要确信试验数据是完整、准确和受到良好控制的,以便对试验分析充满信心并将试验结果转化为日常实践。随着技术的成熟,我们对技术的应用需要以统一的方式进行,以适当解释试验结果。在本文中,我们将回顾辐射治疗临床试验中质量保证的重要性。我们将包括机构和研究者凭证的重要方面,以及确保每个试验以符合规定方式进行的持续流程。我们将提供完整数据集的重要性示例,以确保研究结果的解释。我们将描述过去成功的质量保证策略将如何支持新的倡议。版权所有©2023年 Elsevier Inc. 发表
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.Copyright © 2023. Published by Elsevier Inc.