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Sharing participant-level clinical trial data in public repositories: what are implications for Cochrane reviews?

Date and Location




Monday 23 September 2013 - 13:30 - 15:00


Contact persons and facilitators

Contact person

Karmela Krleza-Jeric
Khaled El Emam


Karmela Krleza-Jeric
Todd Vision
Trish Groves
Target audience

Target audience

Review authors, Cochrane editors, clinical trialists, consumers, members of institutional review boards and research funders

Is your workshop restricted to a specific audience or open to all Colloquium participants?


Level of knowledge required

Type of workshop

Type of workshop

Abstract text


Objectives: To discuss how the Cochrane Collaboration can best build on its call for: "All data from all randomised clinical trials, including raw anonymised individual participant data that do not allow identification of individual participants, and the corresponding trial protocols, to become publicly available free of charge and in easily accessible electronic formats". In particular, we will consider how to make IPD analysis easier to do. This workshop will provide participants with current evidence and examples on: • which data need to be accessed; from where; by whom (roles of triallists, meta-analysts, journals) • public disclosure of clinical trial data through repositories: new platforms with new opportunities; technical and practical exemplars; issues with sharing “on request” vs publicly • risks, fears and benefits of data sharing; the risk of re-identification of trial participants from anonymised datasets vs. the under-utilization of data; risks of data sharing or using by researchers; understanding legal frameworks and international policies; Description: The 90 minutes workshop will consist of • four 15-minute presentations on the above topics • followed by 4 concurrent breakout groups for 20 minutes each • a final 10 minute discussion focusing on potential ways of operationalization of the Cochrane policy at: