Lisbona A, Llagostera C
9, rue Jacques-Offenbach, 44800 Saint-Herblain, France; Service de physique médicale, Institut de cancérologie de l'Ouest, boulevard Jacques-Monod, 44805 Saint-Herblain, France.
9, rue Jacques-Offenbach, 44800 Saint-Herblain, France; Service de physique médicale, Institut de cancérologie de l'Ouest, boulevard Jacques-Monod, 44805 Saint-Herblain, France.
Cancer Radiother. 2022 Oct;26(6-7):814-817. doi: 10.1016/j.canrad.2022.06.022. Epub 2022 Aug 30.
Quality assurance for radiotherapy of a clinical trial is an important step from the design of the clinical trial. A precise definition of quality assurance must be given in detail in the clinical protocol of the clinical trial. By its implementation, quality assurance allows a homogeneity of the clinical trial, which can lead to a reduction of the biases of results interpretation for the clinical trial. The complexity of the radiotherapy to be carried out within the framework of the clinical trial can induce a gradation for the radiotherapy quality assurance program of the trial. However, the following steps are always present and must be described either directly in the clinical protocol or in a specific chapter, radiotherapy quality assurance, of the clinical protocol. The detailed characteristics of the medical imaging required to prepare for the treatment, the delineation of the targets and organs at risk, the requirements related to the planning, the treatment itself, possibly including the positioning repositioning control images, of the patient. For the delineation and planning stages, it is common to set up benchmarking based on test cases (dummy run, dry run). Their validation makes it possible for the center to get credentials for the clinical trial. Some trials can provide for an additional quality assurance point, such End-to-End test for which the investigating center must carry out, according to the clinical protocol, the preparation, the planning, the treatment on an anthropomorphic test object containing models of targets, organs at risk as well as dosimeters. Quality assurance of radiotherapy in clinical research is an essential part to be taken into account from the design of the clinical study. The commitment of the investigating center in terms of human and material resources in compliance with the protocol and in the quality assurance of the trial constitute a guarantee of limitation of the biases for the study and its interpretation, facilitating the answer of the scientific question asked by the trial.
临床试验放射治疗的质量保证是从临床试验设计开始的重要一步。必须在临床试验的临床方案中详细给出质量保证的精确定义。通过实施质量保证，可使临床试验具有同质性，这有助于减少临床试验结果解释中的偏差。在临床试验框架内进行的放射治疗的复杂性可能导致试验放射治疗质量保证计划的分级。然而，以下步骤始终存在，必须直接在临床方案中或在临床方案的特定章节“放射治疗质量保证”中进行描述。包括治疗准备所需医学影像的详细特征、靶区和危及器官的勾画、与计划相关的要求、治疗本身（可能包括患者的定位、重新定位及对照影像）。对于勾画和计划阶段，通常会基于测试病例（模拟运行、预演）建立基准测试。其验证可使中心获得临床试验的资质。一些试验可能会设置额外的质量保证点，例如端到端测试，研究中心必须根据临床方案，在包含靶区模型、危及器官模型以及剂量计的人体模型上进行准备、计划和治疗。临床研究中放射治疗的质量保证是临床研究设计中必须考虑的重要部分。研究中心在人力和物力资源方面遵守方案以及对试验进行质量保证，是限制研究及其解释偏差的保证，有助于回答试验提出的科学问题。
