The Importance of Quality Assurance in Radiation Clinical Trials

被引:0
|
作者
Fitzgerald, Thomas J. [1 ]
Bishop-Jodoin, Maryann [1 ]
Laurie, Fran [1 ]
Iandoli, Matthew [1 ]
Smith, Koren [1 ]
Ulin, Kenneth [1 ]
Ding, Linda [1 ]
Moni, Janaki [1 ]
Cicchetti, M. Giulia [1 ,2 ]
Knopp, Michael
Kry, Stephen [3 ]
Xiao, Ying [4 ]
Rosen, Mark
Prior, Fred [5 ]
Saltz, Joel [6 ]
Michalski, Jeff [7 ]
机构
[1] UMass Chan Med Sch, Dept Radiat Oncol, Worcester, MA 01655 USA
[2] Univ Cincinnati, Dept Radiol, Cincinnati, OH USA
[3] MD Anderson Canc Ctr, Dept Radiat Phys, Houston, TX USA
[4] Univ Penn, Dept Radiat Oncol, Philadelphia, PA USA
[5] Univ Arkansas Med Sci, Dept Biomed Informat, Little Rock, AR USA
[6] SUNY Stony Brook, Dept Biomed Informat, Stony Brook, NY USA
[7] Washington Univ St Louis, Dept Radiat Oncol, St Louis, MO USA
关键词
INVOLVED-FIELD RADIOTHERAPY; BREAST-CANCER; ONCOLOGY; THERAPY; CHEMOTHERAPY; PACLITAXEL; CONCURRENT; OUTCOMES; IMPACT; QA;
D O I
10.1016/j.semradonc.2023.06.005
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.Semin Radiat Oncol 33:395-406 (c) 2023 Published by Elsevier Inc.
引用
收藏
页码:395 / 406
页数:12
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