Data sharing: Experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine

Abstract

Objectives Meta-analysis based on individual patient data (IPD) from randomised trials is superior to using published summary data since it facilitates subgroup and multiple variable analyses. Guidelines and funders expect that researchers share IPD for bona fide analyses, but in practice, this is done variably. Here, we report the experience of obtaining IPD for two collaborative analysis studies. Setting Two linked studies required IPD from published randomised trials. The leading researchers for eligible trials were approached and asked to share IPD including trial characteristics, patient demographics, baseline clinical data and outcome measures. Participants Participants in eligible randomised controlled trials included patients with or at risk of cognitive decline/vascular events. Primary and secondary outcome measures Numbers (%) of trials where the leading researcher responded favourably/negatively or did not respond. If negative, reasons behind the response were collected. If positive, methods used to share IPD were recorded. Results Across the two studies, 391 completed trials were identified. Email addresses for researchers were found for 313 (80%) of the trials. One hundred and forty-eight (47%) researchers did not respond despite being sent multiple emails. Following contact, positive initial responses were received from 92 researchers, resulting in IPD being shared for 78 trials. Eighty-seven (28%) researchers declined to share data; justifications were recorded. The median time from first request to accessing data in one study was 241 (IQR 383.3) days. IPD sources included: direct from researcher, via academic trial funders repository and a website requiring remote analysis of commercial data. Where data were shared, a variety of methods were used to transfer data. Conclusion Sharing of IPD from trials is desirable and a requirement of many funding bodies. However, accessing IPD faces multiple challenges including refusals to share, delays in access to data and having to perform analyses on a remote website. Trial registration Not applicable.