Murugiah Karthik, Ritchie Jessica D, Desai Nihar R, Ross Joseph S, Krumholz Harlan M
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT.
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.
J Am Heart Assoc. 2016 Apr 20;5(4):e003307. doi: 10.1161/JAHA.116.003307.
Industry-sponsored clinical trials produce high-quality data sets that can be used by researchers to generate new knowledge. We assessed the availability of individual participant-level data (IPD) from large cardiovascular trials conducted by major pharmaceutical companies and compiled a list of available trials.
We identified all randomized cardiovascular interventional trials registered on ClinicalTrials.gov with >5000 enrollment, sponsored by 1 of the top 20 pharmaceutical companies by 2014 global sales. Availability of IPD for each trial was ascertained by searching each company's website/data-sharing portal. If availability could not be determined, each company was contacted electronically. Of 60 included trials, IPD are available for 15 trials (25%) consisting of 204 452 patients. IPD are unavailable for 15 trials (25%). Reasons for unavailability were: cosponsor did not agree to make IPD available (4 trials) and trials were not conducted within a specific time (5 trials); for the remaining 6 trials, no specific reason was provided. For 30 trials (50%), availability of IPD could not be definitively determined either because of no response or requirements for a full proposal (23 trials).
IPD from 1 in 4 large cardiovascular trials conducted by major pharmaceutical companies are confirmed available to researchers for secondary research, a valuable opportunity to enhance science. However, IPD from 1 in 4 trials are not available, and data availability could not be definitively determined for half of our sample. For several of these trials, companies require a full proposal to determine availability, making use of the IPD by researchers less certain.
行业资助的临床试验可产生高质量数据集，供研究人员用于生成新知识。我们评估了大型心血管试验中主要制药公司开展的个体参与者水平数据（IPD）的可获取性，并编制了一份可用试验清单。
我们识别了在ClinicalTrials.gov上注册的、入组人数超过5000且由2014年全球销售额排名前20的制药公司之一资助的所有随机心血管介入试验。通过搜索每家公司的网站/数据共享门户来确定每项试验的IPD可获取性。如果无法确定可获取性，则通过电子邮件联系每家公司。在纳入的60项试验中，有15项试验（25%）可获取IPD，涉及204452名患者。15项试验（25%）无法获取IPD。无法获取的原因包括：共同资助方不同意提供IPD（4项试验）以及试验并非在特定时间内开展（5项试验）；其余6项试验未给出具体原因。对于30项试验（50%），由于未得到回复或需要完整提案（23项试验），无法明确确定IPD的可获取性。
主要制药公司开展的四分之一大型心血管试验的IPD已确认可供研究人员进行二次研究，这是提升科学水平的宝贵机会。然而，四分之一试验的IPD无法获取，并且我们样本中一半试验的数据可获取性无法明确确定。对于其中一些试验，公司要求提供完整提案来确定可获取性，这使得研究人员利用IPD的情况更不确定。
