Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., A.Q., D.L.B.).
Department of Medicine, Massachusetts General Hospital, Boston (A.N.).
Circulation. 2018 Feb 27;137(9):938-947. doi: 10.1161/CIRCULATIONAHA.117.031883. Epub 2017 Nov 13.
Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials.
We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies.
From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement.
Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.
分享患者水平临床试验数据已得到广泛认可。但是，对于这些数据在代谢心血管疾病领域的应用程度，我们知之甚少。本研究旨在评估代谢心血管临床试验共享数据的可用性和使用情况。
我们从ClinicalStudyDataRequest.com 中提取数据，该平台是一个大型的多赞助商数据共享平台，其中包含 13 家制药公司赞助的已完成研究的个体患者水平数据。
从 2013 年 1 月至 2017 年 5 月，该平台拥有 3374 项临床试验的数据，其中 537 项（16%）评估了代谢心血管治疗方法（1 期占 36%；2 期占 17%；2/3 期占 1%；3 期占 42%；4 期占 4%）。这些试验涵盖了 74 种疗法和 398925 名患者。糖尿病（60%）和高血压（15%）是最常见的研究主题。从研究完成到数据可用的中位时间为 79 个月。截至 2017 年 5 月，ClinicalStudyDataRequest.com 已收到 318 份提交的提案，其中 163 份已签署数据共享协议。这些提案中有 30 份与代谢心血管治疗方法相关，从 79 项独特的研究中请求数据（占所有试验的 15%，占 3/4 期试验的 29%）。代谢心血管临床试验数据请求者主要来自北美和西欧的学术中心，其中一半的提案未获得资助。大多数提案是为了生成次要假设问题，只有 1 个提案是对原始研究主要假设的重新分析。截至目前，自数据共享协议签署后中位数为 19 个月（9-32 个月）后，有 3 篇经过同行评审的文章发表。
尽管在一个多赞助商数据共享平台上提供了超过 500 项代谢心血管试验的数据，但迄今为止，只有 15%的这些试验和 29%的 3/4 期试验被研究人员访问，并且只有极少数的分析达到了发表水平。
