Corrigan Kelsey L, Kry Stephen, Howell Rebecca M, Kouzy Ramez, Jaoude Joseph Abi, Patel Roshal R, Jhingran Anuja, Taniguchi Cullen, Koong Albert C, McAleer Mary Fran, Nitsch Paige, Rödel Claus, Fokas Emmanouil, Minsky Bruce D, Das Prajnan, Fuller C David, Ludmir Ethan B
The University of Texas MD Anderson Cancer Center, Houston, USA.
University of Frankfurt, Frankfurt, Germany; German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany.
Radiother Oncol. 2022 Jan;166:51-57. doi: 10.1016/j.radonc.2021.11.018. Epub 2021 Nov 25.
Quality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT).
We searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson's Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials.
Forty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p = 0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p < 0.001).
There is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.
质量保证（QA）措施通过确保方案得到遵循且结果有效且可重复，提高了肿瘤学试验的质量水平。本研究调查了涉及放射治疗（RT）的随机对照试验中QA的应用情况。
2020年2月，我们在ClinicalTrials.gov上搜索了所有III期肿瘤学随机临床试验（RCT）。对这些试验进行筛选，以找出已发表主要试验结果的RT特异性RCT。如果可能，从研究出版物和试验方案中收集每个试验中有关QA的信息。两名研究人员独立进行试验筛选和数据收集。采用Pearson卡方检验分析来评估与RT试验中包含QA相关的因素。
分析了42项以RT作为主要干预措施或作为方案强制组成部分的RCT；最早的试验始于1994年，有一项试验仍在进行但未招募患者。29项（69%）试验将RT质量保证（RTQA）措施作为试验方案的一部分，其中19项（45%）试验要求机构认证。21项（50%）试验公布了方案偏离结果。与未采用这些先进技术的试验相比，涉及先进放射技术（调强放疗、容积调强弧形放疗、立体定向放射治疗、立体定向体部放疗）的临床试验并未包含更多的RTQA（73%对65%，p = 0.55）。与未报告这些结果的试验相比，报告方案偏离结果的试验在其方案中更倾向于强制实施RTQA（100%对38%，p < 0.001）。
RT临床试验中缺乏RTQA的应用和透明度。对于RT试验而言，必须增加QA以实现安全、一致且高质量的RT计划和实施。
