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

被引:68
作者
Rathi, Vinay
Dzara, Kristina [1 ]
Gross, Cary P. [1 ,2 ]
Hrynaszkiewicz, Iain [3 ]
Joffe, Steven [4 ,5 ]
Krumholz, Harlan M. [2 ,6 ,7 ,8 ]
Strait, Kelly M. [6 ]
Ross, Joseph S. [1 ,2 ,6 ]
机构
[1] Yale Univ, Sch Med, Gen Internal Med Sect, Dept Med, New Haven, CT 06520 USA
[2] Yale Univ, Sch Med, Dept Med, Robert Wood Johnson Fdn Clin Scholars Program, New Haven, CT 06510 USA
[3] BioMed Cent, London, England
[4] Dana Farber Canc Inst, Dept Pediat Oncol, Boston, MA 02115 USA
[5] Boston Childrens Hosp, Dept Med, Boston, MA USA
[6] Yale New Haven Hosp, Ctr Outcomes Res & Evaluat, New Haven, CT 06504 USA
[7] Yale Univ, Sch Med, Dept Med, Sect Cardiovasc Med, New Haven, CT 06510 USA
[8] Yale Univ, Sch Epidemiol & Publ Hlth, New Haven, CT USA
来源
BMJ-BRITISH MEDICAL JOURNAL | 2012年 / 345卷
关键词
ACCESS; TRANSPARENCY; GENETICS; IMPROVE; SCIENCE; AUTHORS;
D O I
10.1136/bmj.e7570
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:10
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