Portal de Periódicos da CAPES

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

2016; Public Library of Science; Volume: 13; Issue: 1 Linguagem: Inglês

10.1371/journal.pmed.1001946

1549-1676

Deborah A. Zarin, Tony Tse,

Mental Health and Patient Involvement

The Institute of Medicine (IOM) [1], journal editors [2,3], and many others [4][5][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].Additional proposed benefits include the ability to reanalyze study data (e.g., validation and/or correction 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 reporting 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 enterprise (CRE) [11].In this essay, we attempt to add precision to the ongoing discussion by examining the range of information granularity associated with different types of IPD.We then consider IPD sharing within a three-level TRS framework and illustrate the roles of these levels with a case study.