The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, Massachusetts, United States of America.
Department of Medicine, Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts Harvard Medical School, Boston, Massachussetts, United States of America.
PLoS One. 2020 Feb 18;15(2):e0226143. doi: 10.1371/journal.pone.0226143. eCollection 2020.
In June 2017, the International Committee of Medical Journal Editors (ICMJE) announced a requirement that authors reporting the results of clinical trials to journals that follow ICMJE recommendations must include an individual participant data (IPD) sharing statement with manuscripts submitted after 01 July 2018. Additionally, all new clinical trials for which enrollment began on or after 01 January 2019 must include a data sharing statement in the trial's publicly posted registration. This study sought to understand whether IPD sharing statements of clinical trials first registered on ClinicalTrials.gov before 01 January 2019 reflected comprehension of the expectations and a willingness to share. To establish baseline characteristics for the prevalence and quality of IPD sharing statements, we examined IPD sharing statements among 2,040 clinical trials first posted on ClinicalTrials.gov between 01 January 2018 and 06 June 2018. Two independent coders further analyzed the quality of the IPD sharing statements of trials whose registration records indicated the intent to share IPD. The vast majority of trials included in this study did not indicate an intent to share IPD (n = 1,928; 94.5%). Among the trials that did commit to sharing IPD (n = 112, 5.5%), significant variability existed in the content and structure of IPD sharing statements. The results of this study suggest that successful compliance with the IPD sharing statement requirements of the ICMJE will require further clarification, enhanced education, and outreach to investigators.
2017 年 6 月，国际医学期刊编辑委员会（ICMJE）宣布要求遵循 ICMJE 建议的期刊的作者在向期刊提交报告临床试验结果的文稿时，必须包含一份个体参与者数据（IPD）共享声明，该声明适用于 2018 年 7 月 1 日之后提交的文稿。此外，所有于 2019 年 1 月 1 日或之后开始入组的新临床试验必须在试验的公开注册中包含数据共享声明。本研究旨在了解在 2019 年 1 月 1 日之前首先在 ClinicalTrials.gov 上注册的临床试验的 IPD 共享声明是否反映了对预期的理解和共享意愿。为了确定 IPD 共享声明的普遍性和质量的基线特征，我们检查了 2018 年 1 月 1 日至 2018 年 6 月 6 日期间首次在 ClinicalTrials.gov 上发布的 2040 项临床试验的 IPD 共享声明。两位独立的编码员进一步分析了那些注册记录表明有意共享 IPD 的试验的 IPD 共享声明的质量。本研究纳入的绝大多数试验都没有表明有意共享 IPD（n=1928；94.5%）。在承诺共享 IPD 的试验中（n=112，5.5%），IPD 共享声明的内容和结构存在显著差异。本研究结果表明，要成功遵守 ICMJE 的 IPD 共享声明要求，还需要进一步澄清、加强教育和向研究者宣传。
