ESSAY Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting

The Institute of Medicine (IOM) [1], journal editors [2,3], and many others [4–6] have called for more widespread, third-party access to the individual participant data (IPD) and associated documentation from clinical trials (i.e., “IPD sharing”). Advocates assert that access to trial IPD will help to address well-established flaws in the current system of communicating trial results, including nonpublication, selective reporting, and lack of reproducibility [7]. Addi-tional proposed benefits include the ability to reanalyze study data (e.g., validation and/or cor-rection of previously published findings [8]) and to combine data from multiple studies (e.g., IPD-level meta-analyses [9]). Others note the burdens and costs associated with preparing IPD and associated documentation for sharing, the need to ensure participant privacy, and the risk of invalid analyses [10]. We do not attempt to replicate the more comprehensive analysis of IPD sharing that was conducted by the recent IOM panel [1]. However, we believe that it would be helpful at this pivotal time to consider the implications of IPD sharing within the context of the “trial report-ing system ” (TRS), which encompasses existing efforts to enhance access to information about trials and their findings and to improve the transparency of the clinical research enterpris