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BMJ Open. 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.

Author information

1
European Clinical Research Infrastructure Network (ECRIN), Düsseldorf, Germany.
2
IRCCS - Istituto di Ricerche Farmacologiche 'Mario Negri' (IRFMN), Milan, Italy.
3
Canham Information Systems, Surrey, UK.
4
European Clinical Research Infrastructure Network (ECRIN), Paris, France.
5
CSC IT Center for Science, Espoo, Finland.
6
Clinical Data Interchange Standards Consortium, Austin, Texas, USA.
7
MRCT Center of BWH and Harvard, Brigham and Women's Hospital and Harvard University, Boston, Massachusetts, USA.
8
Wellcome Trust Sanger Institute, Cambridge, UK.
9
European Medicines Agency, London, UK.
10
Ethics, Collections and History of Medicine of the Medical University of Vienna, Vienna, Austria.
11
BioMed Central, London, UK.
12
DataCite, Hanover, Germany.
13
National Institutes of Health/National Cancer Institute, Bethesda, Maryland, USA.
14
National Health and Medical Research Council, Watson, Australian Capital Territory, Australia.
15
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
16
BMJ Editorial, BMJ Editorial BMA House, London, UK.
17
World Health Organisation/Organisation mondiale de la santé, Geneva, Switzerland.
18
The European Institute for Innovation through Health Data, Ghent, Belgium.
19
Medical Research Council, London, UK.
20
Ottawa Group-IMPACT, Montreal, Quebec, Canada.
21
Coordination Centre for Clinical Trials, Heinrich Heine University, Düsseldorf, Germany.
22
Catalysis, Austin, Texas, USA.
23
Formerly Clinical Data Interchange Standards Consortium, Austin, Texas, USA.
24
European AIDS Treatment Group (EATG), Lisbon, Portugal.
25
TrialGrid Limited, London, UK.
26
Formerly Medidata Solutions, Hammersmith, UK.
27
Wellcome Trust, London, UK.
28
METHODS Team, INSERM UMR-S 1153, Paris, France.
29
Biobanking and BioMolecular Resources Research Infrastructure (BBMRI), Berlin, Germany.
30
Faculty of 1000, London, UK.
31
Institute of Theoretical Surgery, Philipps University, Marburg, Germany.
32
European Molecular Biology Laboratory, European Bioinformatics Institute, EMBL-EBI, Hinxton, UK.
33
Department of Biostatistics, University of Liverpool, Liverpool, UK.
34
MLC Foundation, Den Haag, The Netherlands.
35
Medlawconsult, The Hague, The Netherlands.
36
Trial Data Solutions, Amsterdam, The Netherlands.

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

PMID:
29247106
PMCID:
PMC5736032
DOI:
10.1136/bmjopen-2017-018647
[Indexed for MEDLINE]
Free PMC Article

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.

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