Underreporting of Research Biopsies from Clinical Trials in Oncology.
Underreporting of Research Biopsies from Clinical Trials in Oncology.
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DOI：
10.1158/1078-0432.ccr-17-1449
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发表时间：
2017-11-01
期刊：
影响因子：
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通讯作者：
Overman MJ
中科院分区：
文献类型：
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作者：
Parseghian CM;Raghav K;Wolff RA;Ensor J Jr;Yao J;Ellis LM;Tam AL;Overman MJ
研究活检经常被纳入肿瘤学临床试验中，并且通常是试验注册的强制性要求。然而，关于研究活检报告的范围和完整性的信息有限。我们从我们机构的 IR 数据库中确定了一组治疗性临床试验，其中在 2005 年 1 月至 2010 年 10 月期间进行了非诊断研究活检。将临床试验方案与最高水平的相应出版物（作为手稿或注册报告）进行比较。 46 项临床试验总共进行了 866 例研究活检，每项试验中平均有 8 名患者进行了活检，每项试验收集了 19 名活检患者。试验完成后中位随访时间为 4.3 年，36/46 项试验 (78%) 报告了试验结果：已发表的手稿 (n=35) 或注册报告 (n=1)。 46 项试验中的 18 项（39%）报告了总共 635 例活检。这 18 项试验中有 6 项 (33%) 少报了活检数量。在 33 项强制进行研究性活检的试验中，13 项 (39%) 试验报告了这些活检。 8 项试验中发生了活检并发症（n=39 名患者，6 例 3/4 级 AE），但只有 1 项试验报告了这些并发症。与活检报告相关的因素包括大量活检（P≤0.001）和连续活检（P<0.001）。进行了 > 12 次活检的 16 项试验中，有 12 项 (75%) 报告了这些活检，而只有 20% (6/30) 进行了 ≤ 12 次活检。尽管有报告研究活检的道德义务，但大多数试验（61%）并未报告研究活检的结果。这些研究中很少报告并发症。需要改进研究活检结果和不良事件的报告。
Research biopsies are frequently incorporated within clinical trials in oncology, and are often a mandatory requirement for trial enrollment. However, limited information is available regarding the extent and completeness of research biopsy reporting. We identified a cohort of therapeutic clinical trials where non-diagnostic research biopsies were performed between January, 2005-October, 2010 from an IR database at our institution. Clinical trial protocols were compared with the highest level of corresponding publication as a manuscript or registry report. A total of 866 research biopsies were performed across 46 clinical trials, with a median of 8 patients biopsied/trial and 19 biopsies collected/trial. After a median follow-up time of 4.3 years from trial completion, 36/46 trials (78%) reported trial results: published manuscripts (n=35), or registry report (n=1). A total of 635 conducted biopsies were reported in 18 of the 46 trials (39%). Six (33%) of these 18 trials under-reported the number of biopsies performed. Of 33 trials with mandatory research biopsies, 13 (39%) trials reported on these biopsies. Biopsy complications occurred in 8 trials (n=39 patients, 6 Grade 3/4 AEs) but only 1 trial reported these. Factors associated with biopsy reporting included a larger number of biopsies (P≤0.001), and serial biopsies (P<0.001). Twelve of 16 (75%) trials with >12 biopsies performed reported on these biopsies compared to only 20%(6/30) that performed ≤12 biopsies. Despite ethical obligations to report research biopsies, the majority (61%) of trials do not report results from research biopsies. Complications are rarely reported in these studies. Improved reporting of results and AEs from research biopsies is needed.