@article{discovery10040511,
           month = {December},
            note = {Copyright {\copyright} 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.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/},
          number = {12},
           title = {Sharing and reuse of individual participant data from clinical trials: principles and recommendations},
         journal = {BMJ Open},
            year = {2017},
          volume = {7},
        keywords = {clinical trials, consensus conference, data sharing, individual participant data},
          author = {Ohmann, C and Banzi, R and Canham, S and Battaglia, S and Matei, M and Ariyo, C and Becnel, L and Bierer, B and Bowers, S and Clivio, L and Dias, M and Druml, C and Faure, H and Fenner, M and Galvez, J and Ghersi, D and Gluud, C and Groves, T and Houston, P and Karam, G and Kalra, D and Knowles, RL and Krle{\vz}a-Jeri{\'c}, K and Kubiak, C and Kuchinke, W and Kush, R and Lukkarinen, A and Marques, PS and Newbigging, A and O'Callaghan, J and Ravaud, P and Schl{\"u}nder, I and Shanahan, D and Sitter, H and Spalding, D and Tudur-Smith, C and van Reusel, P and van Veen, E-B and Visser, GR and Wilson, J and Demotes-Mainard, J},
            issn = {2044-6055},
             url = {http://doi.org/10.1136/bmjopen-2017-018647},
        abstract = {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.}
}