Chapman Paul B, Liu Nathan J, Zhou Qin, Iasonos Alexia, Hanley Sara, Bosl George J, Spriggs David R
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, United States of America.
Weill Cornell Medical College, New York, New York, United States of America.
PLoS One. 2017 Sep 21;12(9):e0184025. doi: 10.1371/journal.pone.0184025. eCollection 2017.
Very little is known about the proportion of oncology trials that get published, the time it takes to publish them, or the reasons why oncology trials do not get published.
We analyzed all clinical trials that closed to accrual at our cancer center between 2009-2013. Trials were categorized by study purpose (therapeutic vs. diagnostic), phase (pilot, phase I, II, or III), and sponsor (industrial, cooperative group, institutional, or peer-reviewed). Final publications were identified in MEDLINE and EMBASE by NCT numbers, or by querying the principal investigator. For trials not published, we surveyed the principal investigators to identify the reason for non-publication.
469 of 809 protocols (58%) had been published by November 2016. The calculated probability of publication 7 years after completing accrual was 70.4%; the calculated median time to publication was 47 months. Only 18.8% of protocols overall were estimated to be published within 2 years from completing accrual. The calculated probability of publication was higher for therapeutic trials than non-therapeutic trials, but there was no difference based on phase or sponsor. Among protocols not published, 45.3% had completed accrual, and among these, a majority had a manuscript in preparation or review, or the trial was still collecting data. Failure to publish due to a pharmaceutical sponsor was rare. 30.6% of unpublished trials had closed for various reasons before completing accrual, usually due to poor accrual or pharmaceutical sponsor issues.
Almost 30% of trials were calculated to be unpublished by 7 years after closing to accrual at our institution. Failure to reach accrual goals was an important factor in non-publication. We have devised new institutional policies that identify trials likely not to meet accrual goals and require early closure. We should be able to shorten the time from accrual completion to publication, especially for pilot and phase I trials for which long follow up is not needed.
关于肿瘤学试验的发表比例、发表所需时间，以及肿瘤学试验未发表的原因，我们所知甚少。
我们分析了2009年至2013年间在我们癌症中心停止入组的所有临床试验。试验按研究目的（治疗性与诊断性）、阶段（试点、I期、II期或III期）和申办方（行业、合作组、机构或同行评审）进行分类。通过NCT编号在MEDLINE和EMBASE中识别最终发表情况，或向主要研究者查询。对于未发表的试验，我们调查了主要研究者以确定未发表的原因。
到2016年11月，809项方案中有469项（58%）已发表。完成入组7年后的计算发表概率为70.4%；计算得出的中位发表时间为47个月。估计总体只有18.8%的方案在完成入组后2年内发表。治疗性试验的计算发表概率高于非治疗性试验，但基于阶段或申办方没有差异。在未发表的方案中，45.3%已完成入组，其中大多数有稿件正在准备或评审，或者试验仍在收集数据。因制药申办方而未发表的情况很少见。30.6%的未发表试验在完成入组前因各种原因提前结束，通常是由于入组不佳或制药申办方问题。
据计算，在我们机构停止入组7年后，近30%的试验未发表。未达到入组目标是未发表的一个重要因素。我们制定了新的机构政策，识别可能无法达到入组目标的试验并要求提前结束。我们应该能够缩短从完成入组到发表的时间，特别是对于不需要长期随访的试点和I期试验。
