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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >QA makes a clinical trial stronger: Evidence-based medicine in radiation therapy
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QA makes a clinical trial stronger: Evidence-based medicine in radiation therapy

机译：质量保证使临床试验更强大：放射疗法中的循证医学

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Quality assurance (QA) for radiation therapy (RT) in clinical trials is necessary to ensure treatment is safely and effectively administered. QA assurance requires however substantial human and financial resources, as it has become more comprehensive and labor intensive in recent RT trials. It is presumed that RT deviations decrease therapeutic effectiveness of the studied regimen. This study assesses the impact of RT protocol-deviations on patient's outcome in prospective phase II-III RT trials. PubMed, Medline and Embase identified nine prospective RT trials detailing QA RT violation and patient's outcome. Planned QA analysis was preformed retrospectively and prospectively in eight and one studies, respectively. Non-adherence to protocol-specified RT requirements in prospective trials is frequent: the observed major deviation rates range from 11.8% to 48.0% (mean, 28.1 ± 17.9%). QA RT deviations had a significant impact on the primary study end-point in a majority (62.5%) of studies. The number of patients accrued per center was a significant predictive factor for RT deviations in the largest series. These QA data stemming from prospective clinical trials show undisputedly that non adherence to protocol-specified RT requirements is associated with reduced survival, local control and potentially increased toxicity.
机译：在临床试验中，放射治疗（RT）的质量保证（QA）对于确保安全有效地进行治疗是必要的。但是，质量保证保证需要大量的人力和财力，因为在最近的放射治疗试验中，质量保证变得更加全面和劳动密集。据推测，RT偏差降低了所研究方案的治疗效果。这项研究评估了前瞻性II-III期RT试验中RT方案偏离对患者预后的影响。 PubMed，Medline和Embase确定了9项前瞻性RT试验，详细介绍了QA RT违规和患者的预后。计划性QA分析分别在八项研究和一项研究中进行了回顾性和前瞻性研究。在前瞻性试验中，经常不遵守协议规定的RT要求：观察到的主要偏差率在11.8％至48.0％之间（平均28.1±17.9％）。 QA RT偏差对大多数研究（62.5％）的主要研究终点有重大影响。每个中心所累积的患者数量是最大系列中RT偏差的重要预测因素。这些来自前瞻性临床试验的QA数据无疑表明，不遵守协议规定的RT要求与生存率降低，局部控制和潜在的毒性增加相关。

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