Abstract
BackgroundShifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations.MethodsWe systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD.ResultsOur scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed.For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues.ConclusionsKnowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.
Highlights
Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies
IPD meta-analyses (IPDMAs) researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing
We describe the key challenges and propose solutions to navigate obstacles commonly associated with IPDMA in the light of recent changes in data sharing policy and practice [16, 47, 77]
Summary
Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. The number of IPD meta-analyses (IPDMAs) is increasing. A meta-analysis may combine study level data or individual participant level data. Individual participant data (IPD) meta-analyses (MA) combine data from each specific participant from multiple studies into a single dataset for further analysis [4]. IPDMA are considered the “gold standard” [5,6,7,8,9] and possibly preferred to study level meta-analyses because they allow researchers to use the most current and comprehensive data, verify the findings of previous investigations, apply uniform definitions and analyses across studies, and avoid potential ecological bias when investigating interactions between interventions and patient-level characteristics (effect modifications, subgroup effects) [7, 8, 10,11,12]. Similar to systematic reviews and study level meta-analyses, IPDMAs often influence practice guidelines and the design of new trials [13, 14]
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