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

J 2017

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

OHMANN, C., R. BANZI, S. CANHAM, S. BATTAGLIA, M. MATEI et. al.

Basic information

Original name

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

Authors

Edition

BMJ Open, London, BMJ Publishing Group, 2017, 2044-6055

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30218 General and internal medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.413

RIV identification code

RIV/00216224:14110/17:00121479

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1136/bmjopen-2017-018647

UT WoS

000423826700163

Keywords in English

clinical trials; individual participant data

Abstract

V originále

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.

Links

90090, large research infrastructures

Name: CZECRIN II

Citovat

OHMANN, C., R. BANZI, S. CANHAM, S. BATTAGLIA, M. MATEI, C. ARIYO, L. BECNEL, B. BIERER, S. BOWERS, L. CLIVIO, M. DIAS, C. DRUML, H. FAURE, M. FENNER, J. GALVEZ, D. GHERSI, C. GLUUD, T. GROVES, P. HOUSTON, G. KARAM, D. KALRA, R. L. KNOWLES, K. KRLEZA-JERIC, C. KUBIAK, W. KUCHINKE, R. KUSH, A. LUKKARINEN, P. S. MARQUES, A. NEWBIGGING, J. O CALLAGHAN, P. RAVAUD, I. SCHLUNDER, D. SHANAHAN, H. SITTER, D. SPALDING, C. TUDUR-SMITH, P. VAN REUSEL, E. B. VAN VEEN, G. R. VISSER, J. WILSON and J. DEMOTES-MAINARD. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. London: BMJ Publishing Group, 2017, vol. 7, No 12, p. 1-24. ISSN 2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2017-018647.

@article{1763916,
   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, R. L. and KrlezaandJeric, K. and Kubiak, C. and Kuchinke, W. and Kush, R. and Lukkarinen, A. and Marques, P. S. and Newbigging, A. and O Callaghan, J. and Ravaud, P. and Schlunder, I. and Shanahan, D. and Sitter, H. and Spalding, D. and TudurandSmith, C. and van Reusel, P. and van Veen, E. B. and Visser, G. R. and Wilson, J. and DemotesandMainard, J.},
   article_location = {London},
   article_number = {12},
   doi = {http://dx.doi.org/10.1136/bmjopen-2017-018647},
   keywords = {clinical trials; individual participant data},
   language = {eng},
   issn = {2044-6055},
   journal = {BMJ Open},
   title = {Sharing and reuse of individual participant data from clinical trials: principles and recommendations},
   url = {https://bmjopen.bmj.com/content/bmjopen/7/12/e018647.full.pdf},
   volume = {7},
   year = {2017}
}

TY  - JOUR
ID  - 1763916
AU  - Ohmann, C. - Banzi, R. - Canham, S. - Battaglia, S. - Matei, M. - Ariyo, C. - Becnel, L. - Bierer, B. - Bowers, S. - Clivio, L. - Dias, M. - Druml, C. - Faure, H. - Fenner, M. - Galvez, J. - Ghersi, D. - Gluud, C. - Groves, T. - Houston, P. - Karam, G. - Kalra, D. - Knowles, R. L. - Krleza-Jeric, K. - Kubiak, C. - Kuchinke, W. - Kush, R. - Lukkarinen, A. - Marques, P. S. - Newbigging, A. - O Callaghan, J. - Ravaud, P. - Schlunder, I. - Shanahan, D. - Sitter, H. - Spalding, D. - Tudur-Smith, C. - van Reusel, P. - van Veen, E. B. - Visser, G. R. - Wilson, J. - Demotes-Mainard, J.
PY  - 2017
TI  - Sharing and reuse of individual participant data from clinical trials: principles and recommendations
JF  - BMJ Open
VL  - 7
IS  - 12
SP  - 1-24
EP  - 1-24
PB  - BMJ Publishing Group
SN  - 20446055
KW  - clinical trials
KW  - individual participant data
UR  - https://bmjopen.bmj.com/content/bmjopen/7/12/e018647.full.pdf
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.
ER  -

OHMANN, C., R. BANZI, S. CANHAM, S. BATTAGLIA, M. MATEI, C. ARIYO, L. BECNEL, B. BIERER, S. BOWERS, L. CLIVIO, M. DIAS, C. DRUML, H. FAURE, M. FENNER, J. GALVEZ, D. GHERSI, C. GLUUD, T. GROVES, P. HOUSTON, G. KARAM, D. KALRA, R. L. KNOWLES, K. KRLEZA-JERIC, C. KUBIAK, W. KUCHINKE, R. KUSH, A. LUKKARINEN, P. S. MARQUES, A. NEWBIGGING, J. O CALLAGHAN, P. RAVAUD, I. SCHLUNDER, D. SHANAHAN, H. SITTER, D. SPALDING, C. TUDUR-SMITH, P. VAN REUSEL, E. B. VAN VEEN, G. R. VISSER, J. WILSON and J. DEMOTES-MAINARD. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. \textit{BMJ Open}. London: BMJ Publishing Group, 2017, vol.~7, No~12, p.~1-24. ISSN~2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2017-018647.

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