Laboratory for medical research and consumer involvement, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Via G. La Masa 19, 20156, Milan, Italy.
J Ovarian Res. 2018 Apr 10;11(1):28. doi: 10.1186/s13048-018-0404-1.
In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results.
Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years.
These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.
近年来，临床研究的透明度问题一直受到临床医生、研究人员、公民及其代表、作者和出版商的争论。对于罕见癌症如卵巢癌来说，这一点尤为重要，因为在大多数情况下，其治疗效果仍不尽如人意。我们的目的是评估公众是否可以在 ClinicalTrials.gov 上获取结果，以及在 ClinicalTrials.gov 以及 PubMed、Embase 和 Google Scholar 上不公布结果的频率。我们收集了 2017 年 1 月 17 日 ClinicalTrials.gov 注册库中所有被认定为“完成状态”的卵巢癌试验。我们检查了 ClinicalTrials.gov 上结果的可用性，并系统地识别了已公布的结果文献。
在确定的 2725 项卵巢癌试验中，有 752 项被归类为“完成状态”。在 2008 年至 2015 年期间关闭的试验中，排除 I 期试验，ClinicalTrials.gov 上结果的频率为 35%。在这 752 项已完成的研究中，在过去几年中，在 PubMed、Embase 或 Google Scholar 上发表的结果的频率从 57.9%到 69.7%不等。
这些发现表明研究的透明度和可信度存在不足。公民或患者代表与医疗界应不断支持改善临床研究结果发布和传播的举措。
