Data from: Sharing of clinical trial data among trialists: a cross sectional survey

Objective: To investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team. Design and setting: Cross sectional, web based survey. Participants: Clinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011. Main outcome measures: Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests. Results: Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents’ most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects. Conclusions: We found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.研究目的：探究临床试验研究者（clinical trialists）对于与非直接合作研究团队的研究者共享临床试验数据的看法与实践经历。 研究设计与实施场景：横断面网络调查。 研究对象：2010年或2011年发表于2011年影响因子最高的6种综合医学期刊之一的临床试验的通讯作者，且为临床试验研究者。 主要结局指标：对通过数据存储库（data repositories）共享数据以及响应个体数据共享请求的支持度与实施率，通过数据存储库共享数据时存在的顾虑，以及同意或拒绝数据共享请求的原因。 结果：在683名潜在受访者中，共计317人完成了本次调查，应答率为46%。原则上，236名受访者（占比74%）认为应强制要求研究者通过数据存储库共享去标识化（de-identified）临床试验数据；另有229名受访者（占比72%）认为应强制要求研究者响应个体请求并共享去标识化临床试验数据。实际操作中，仅56名受访者（占比18%）表示其试验资助方要求将试验数据存储至数据存储库，其中32名受访者（占比57%）已完成数据存储工作。总计149名受访者（占比47%）曾收到过共享临床试验数据的个体请求，其中115名受访者（占比77%）曾同意至少一项数据共享请求，56名受访者（占比38%）曾拒绝至少一项数据共享请求。受访者针对数据共享提出的最常见顾虑涉及数据的合理使用、研究者或资助方的利益诉求，以及研究受试者的权益保护。 结论：本研究发现，参与本次调查的、近期发表于高影响力综合医学期刊的临床试验通讯作者群体，对共享临床试验数据存在较强的支持意愿，包括主动共享数据的意愿，同时也明确了若干实际操作层面的潜在顾虑。