Date of Award

January 2019

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Cary Gross

Abstract

While some have advocated for medical journals to require sharing of clinical trial data, others have raised concerns regarding feasibility, ethical issues, and investigator willingness. We aimed to examine the opinions and experiences of corresponding authors of clinical trial articles who published in high-impact general medical journals that have explicit data sharing policies. We conducted a self-administered online survey of authors of clinical trials published January 1, 2012 through March 1, 2016 in three high-impact journals with policies either requiring all clinical trial authors to share data (PLOS Medicine) or publish a statement in the manuscript specifying whether they were willing to share (The BMJ, Annals of Internal Medicine). We surveyed authors about data sharing plans, responses to actual sharing requests, and willingness to share in response to hypothetical requests. Of 154 eligible trial authors, 90 (58%) responded. Among all respondents, 29% indicated that they had written a data sharing plan, and 52% had addressed data sharing in consent forms. 31 (of 89, 35%) respondents had received at least one data sharing request. Of the 68 requests received, 59 (87%) were granted. In response to scenarios depicting hypothetical requests, 87 (of 90, 97%) indicated they would be willing to share data for a meta-analysis, 66 (73%) would share their data for an analysis focused on replicating their primary study outcome, while only 15 (17%) would share their data for a secondary outcomes analysis if they had planned a similar analysis. In conclusion, about one third of surveyed authors had received at least one data-sharing request. However, many authors indicated a lack of preparation for data sharing and that their willingness to share was dependent on intent to publish a similar analysis.

Comments

This thesis is restricted to Yale network users only. This thesis is permanently embargoed from public release.

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