Developing a topic-based repository of clinical trial individual patient data: experiences and lessons learned from a pilot project



Medley, Nancy ORCID: 0000-0003-0831-3207, Cuthbert, Anna, Crew, Richard ORCID: 0000-0002-5312-8767, Stewart, Lesley, Smith, Catrin Tudur and Alfirevic, Zarko ORCID: 0000-0001-9276-518X
(2021) Developing a topic-based repository of clinical trial individual patient data: experiences and lessons learned from a pilot project. SYSTEMATIC REVIEWS, 10 (1). 162-.

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Abstract

<h4>Background</h4>Building a dataset of individual participant data (IPD) for meta-analysis represents considerable research investment as well as collaboration across multiple institutions and researchers. Making arrangements to curate and share the dataset beyond the IPD meta-analysis project for which it was established, for reuse in future research projects, would maximise the value of this investment.<h4>Methods</h4>Our aim was to establish the Cochrane repository for individual patient data from clinical trials in pregnancy and childbirth (CRIB) as an example of how an IPD repository could become part of Cochrane infrastructure. We believed that establishing CRIB under Cochrane auspices would engender trust and encourage trial investigators to share data, and at the same time position Cochrane to take steps towards expanding the number of reviews with IPD synthesis.<h4>Results</h4>CRIB was designed as a web-based platform to receive, host and facilitate onward sharing of de-identified data. Development was not straightforward and we did not fully achieve our aim as intended. We describe the challenges encountered and suggest ways that future repositories might overcome these. In particular, securing the legal agreements required to facilitate data sharing proved to be the main barrier, being time-consuming and more complex than anticipated.<h4>Conclusions</h4>We would recommend that researchers conducting IPD meta-analysis should consider discussing the option to transfer the curated IPD datasets to a repository at the end of the initial meta-analysis and this should be recognised within the data sharing agreements made with the original data contributors.

Item Type: Article
Uncontrolled Keywords: IPD, Individual patient data, Data sharing, Repository, Barriers
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Faculty of Health and Life Sciences > Tech, Infrastructure and Environmental Directorate
Depositing User: Symplectic Admin
Date Deposited: 04 Jun 2021 14:24
Last Modified: 18 Jan 2023 22:36
DOI: 10.1186/s13643-021-01717-2
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3125096