TY - JOUR
T1 - Sharing and reuse of individual participant data from clinical trials
T2 - principles and recommendations
AU - Ohmann, Christian
AU - Banzi, Rita
AU - Canham, Steve
AU - Battaglia, Serena
AU - Matei, Mihaela
AU - Ariyo, Christopher
AU - Becnel, Lauren
AU - Bierer, Barbara
AU - Bowers, Sarion
AU - Clivio, Luca
AU - Dias, Monica
AU - Druml, Christiane
AU - Faure, Hélène
AU - Fenner, Martin
AU - Galvez, Jose
AU - Ghersi, Davina
AU - Gluud, Christian
AU - Groves, Trish
AU - Houston, Paul
AU - Karam, Ghassan
AU - Kalra, Dipak
AU - Knowles, Rachel L
AU - Krleža-Jerić, Karmela
AU - Kubiak, Christine
AU - Kuchinke, Wolfgang
AU - Kush, Rebecca
AU - Lukkarinen, Ari
AU - Marques, Pedro Silverio
AU - Newbigging, Andrew
AU - O'Callaghan, Jennifer
AU - Ravaud, Philippe
AU - Schlünder, Irene
AU - Shanahan, Daniel
AU - Sitter, Helmut
AU - Spalding, Dylan
AU - Tudur-Smith, Catrin
AU - van Reusel, Peter
AU - van Veen, Evert-Ben
AU - Visser, Gerben Rienk
AU - Wilson, Julia
AU - Demotes-Mainard, Jacques
N1 - © 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.
PY - 2017/12/14
Y1 - 2017/12/14
N2 - OBJECTIVES: We 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 METHODS: This 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.OUTCOME: We developed principles and practical recommendations on how to share data from clinical trials.RESULTS: The 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.CONCLUSIONS: The 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.
AB - OBJECTIVES: We 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 METHODS: This 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.OUTCOME: We developed principles and practical recommendations on how to share data from clinical trials.RESULTS: The 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.CONCLUSIONS: The 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.
KW - Journal Article
U2 - 10.1136/bmjopen-2017-018647
DO - 10.1136/bmjopen-2017-018647
M3 - Journal article
C2 - 29247106
SN - 2044-6055
VL - 7
SP - e018647
JO - BMJ Open
JF - BMJ Open
IS - 12
ER -