Department of Hematological Malignancies and Cellular Therapeutics, Kansas University Medical Center, Kansas City, KS, USA.
Department of Hematological Malignancies and Cellular Therapeutics, Kansas University Medical Center, Kansas City, KS, USA.
Lancet Haematol. 2021 Apr;8(4):e299-e304. doi: 10.1016/S2352-3026(21)00024-7.
To our knowledge, no study has evaluated the quality of control groups in randomised controlled trials of multiple myeloma. We aimed to do a systematic review of randomised controlled trials of multiple myeloma to ascertain the quality of the control groups used. PubMed (MEDLINE), Embase, Cochrane Controlled Register of Trials, and CinicalTrials.gov were searched for articles of randomised controlled trials of multiple myeloma based in the USA that initiated participant enrolment between Jan 1, 2010, and June 30, 2020. A control group regimen was considered to be inferior if a previous randomised controlled trial had shown an improved progression-free survival versus the control group before enrolment. Of 49 identified randomised controlled trials, seven (14%) began enrolling patients into inferior control groups after an existing superior regimen to the control had already been published. Nine (18%) of the 49 trials continued enrolment on substandard control groups after data emerged during the study enrolment period. The median time that newer data emerged regarding inferiority of the control group from the time a trial first enrolled a patient was 13 months (IQR 8-29 months). 12 (75%) of these 16 randomised controlled trials are published, and nine (75%) of the 12 published trials had overlapping investigators with trials that had previously shown the inferiority of the control group being used. Greater scrutiny on the quality of control groups in randomised controlled trials of multiple myeloma is needed.
据我们所知，尚无研究评估多发性骨髓瘤随机对照试验中对照组的质量。我们旨在对多发性骨髓瘤的随机对照试验进行系统评价，以确定所使用对照组的质量。我们在美国检索了发表于 PubMed（MEDLINE）、Embase、Cochrane 对照试验注册库和 ClinicalTrials.gov 的多发性骨髓瘤随机对照试验文章，这些研究的入组时间均在 2010 年 1 月 1 日至 2020 年 6 月 30 日之间。如果一项先前的随机对照试验显示在入组前与对照组相比，实验组的无进展生存期有所提高，则认为对照组方案较差。在 49 项确定的随机对照试验中，有 7 项（14%）在一项优于对照组的方案已经发表后，开始将患者纳入较差的对照组。在研究入组期间出现数据后，有 9 项（18%）的 49 项试验继续纳入不符合标准的对照组。从试验首次入组患者到出现对照组较差的新数据的中位数时间为 13 个月（IQR 8-29 个月）。其中 16 项随机对照试验中有 12 项（75%）有新数据，这 12 项中有 9 项（75%）的研究人员与之前显示对照组较差的试验重叠。需要对多发性骨髓瘤随机对照试验中对照组的质量进行更严格的审查。
