• Christian Ohmann, Rita Banzi, Steve Canham, Serena Battaglia, Mihaela Matei, Christopher Ariyo, Lauren Becnel, Barbara Bierer, Sarion Bowers, Luca Clivio, Monica Dias, Christiane Druml, Hélène Faure, Martin Fenner, Jose Galvez, Davina Ghersi, Christian Gluud, Trish Groves, Paul Houston, Ghassan Karam, Dipak Kalra, Rachel L Knowles, Karmela Krleža-Jerić, Christine Kubiak, Wolfgang Kuchinke, Rebecca Kush, Ari Lukkarinen, Pedro Silverio Marques, Andrew Newbigging, Jennifer O'Callaghan, Philippe Ravaud, Irene Schlünder, Daniel Shanahan, Helmut Sitter, Dylan Spalding, Catrin Tudur-Smith, Peter van Reusel, Evert-Ben van Veen, Gerben Rienk Visser, Julia Wilson, and Jacques Demotes-Mainard.
• European Clinical Research Infrastructure Network (ECRIN), Düsseldorf, Germany.
• BMJ Open. 2017 Dec 14; 7 (12): e018647.

ObjectivesWe examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach.Design And MethodsThis was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European.OutcomeWe developed principles and practical recommendations on how to share data from clinical trials.ResultsThe task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata.ConclusionsThe adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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