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.
- clinical trials
- individual participant data
- data sharing
- consensus conference
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Contributors CO, RB, SC, SeB and MM were members of the core group. The core group’s responsibilities were to establish the multistakeholder taskforce, draft intermediate versions of this report, organise and manage the consensus workshops, coordinate the subgroups, and release the final version of the report and paper. HS acted as independent facilitator of the consensus process, chaired the face-to-face meetings together with CO and was responsible for the methods section of the paper. CA, LB, BB, SaB, LC, MD, CD, HF, MF, JG, DG, CG, TG, PH, GK, DK, RLK, KK-J, CK, WK, RK, AL, PSM, AN, JO, PR, IS, DaS, HS, DyS, CT-S, PvR, E-BvV, GRV and JW were members of the multistakeholder task force, attended at least one of the consensus meetings, provided written feedback during the consensus process to draft manuscripts, and approved the final manuscript. JD-M attended all consensus meetings, was responsible for alignment of the work with the H2020-CORBEL project and approved the final manuscript.
Funding This project has received funding from the European Union’s Horizon 2020 research and innovation programme (CORBEL, under grant agreement n° 654248).
Disclaimer The views expressed by MD in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
Competing interests TG is the editor-in-chief of BMJ Open, the journal that publishes this article. During the paper evaluation she recused herself from the peer review and decision-making process. BB reports various unrestricted gifts (see) supporting travel and effort; grants from Laura and John Arnold Foundation and the Greenwall Foundation during the conduct of the study; and non-financial support from Vivli, outside the submitted work. RK reports she was Founder of CDISC and President during the development of the submitted work. DaS was employed by BioMed Central at the time of the consensus process.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No further data available to share.
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