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. 2017 Dec 14;7(12):e018647.
doi: 10.1136/bmjopen-2017-018647.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

Christian Ohmann  1 , Rita Banzi  2 , Steve Canham  3 , Serena Battaglia  4 , Mihaela Matei  4 , Christopher Ariyo  5 , Lauren Becnel  6 , Barbara Bierer  7 , Sarion Bowers  8 , Luca Clivio  2 , Monica Dias  9 , Christiane Druml  10 , Hélène Faure  11 , Martin Fenner  12 , Jose Galvez  13 , Davina Ghersi  14 , Christian Gluud  15 , Trish Groves  16 , Paul Houston  6 , Ghassan Karam  17 , Dipak Kalra  18 , Rachel L Knowles  19 , Karmela Krleža-Jerić  20 , Christine Kubiak  4 , Wolfgang Kuchinke  21 , Rebecca Kush  22   23 , Ari Lukkarinen  5 , Pedro Silverio Marques  24 , Andrew Newbigging  25   26 , Jennifer O'Callaghan  27 , Philippe Ravaud  28 , Irene Schlünder  29 , Daniel Shanahan  11   30 , Helmut Sitter  31 , Dylan Spalding  32 , Catrin Tudur-Smith  33 , Peter van Reusel  6 , Evert-Ben van Veen  34   35 , Gerben Rienk Visser  36 , Julia Wilson  8 , Jacques Demotes-Mainard  4
Affiliations

Sharing and reuse of individual participant data from clinical trials: principles and recommendations

Christian Ohmann et al. BMJ Open. .

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.

Keywords: clinical trials; consensus conference; data sharing; individual participant data.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Major aspects of sharing and reuse of data from clinical trials. P, principle.
See this image and copyright information in PMC

References

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