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

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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, RL, Krleža-Jerić, K, Kubiak, C, Kuchinke, W, Kush, R, Lukkarinen, A, Marques, PS, Newbigging, A, O'Callaghan, J, Ravaud, P, Schlünder, I, Shanahan, D, Sitter, H, Spalding, D, Tudur-Smith, C, van Reusel, P, van Veen, E-B, Visser, GR, Wilson, J & Demotes-Mainard, J 2017, 'Sharing and reuse of individual participant data from clinical trials: principles and recommendations' BMJ Open, bind 7, nr. 12, s. e018647. https://doi.org/10.1136/bmjopen-2017-018647

APA

Ohmann, C., Banzi, R., Canham, S., Battaglia, S., Matei, M., Ariyo, C., ... Demotes-Mainard, J. (2017). Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open, 7(12), e018647. https://doi.org/10.1136/bmjopen-2017-018647

CBE

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 RL, Krleža-Jerić K, Kubiak C, Kuchinke W, Kush R, Lukkarinen A, Marques PS, Newbigging A, O'Callaghan J, Ravaud P, Schlünder I, Shanahan D, Sitter H, Spalding D, Tudur-Smith C, van Reusel P, van Veen E-B, Visser GR, Wilson J, Demotes-Mainard J. 2017. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 7(12):e018647. https://doi.org/10.1136/bmjopen-2017-018647

MLA

Vancouver

Author

Ohmann, Christian ; Banzi, Rita ; Canham, Steve ; Battaglia, Serena ; Matei, Mihaela ; Ariyo, Christopher ; Becnel, Lauren ; Bierer, Barbara ; Bowers, Sarion ; Clivio, Luca ; Dias, Monica ; Druml, Christiane ; Faure, Hélène ; Fenner, Martin ; Galvez, Jose ; Ghersi, Davina ; Gluud, Christian ; Groves, Trish ; Houston, Paul ; Karam, Ghassan ; Kalra, Dipak ; Knowles, Rachel L ; Krleža-Jerić, Karmela ; Kubiak, Christine ; Kuchinke, Wolfgang ; Kush, Rebecca ; Lukkarinen, Ari ; Marques, Pedro Silverio ; Newbigging, Andrew ; O'Callaghan, Jennifer ; Ravaud, Philippe ; Schlünder, Irene ; Shanahan, Daniel ; Sitter, Helmut ; Spalding, Dylan ; Tudur-Smith, Catrin ; van Reusel, Peter ; van Veen, Evert-Ben ; Visser, Gerben Rienk ; Wilson, Julia ; Demotes-Mainard, Jacques. / Sharing and reuse of individual participant data from clinical trials : principles and recommendations. I: BMJ Open. 2017 ; Bind 7, Nr. 12. s. e018647.

Bibtex

@article{807c92672d6243d18c2a46c395c49f98,
title = "Sharing and reuse of individual participant data from clinical trials: principles and recommendations",
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 = "Journal Article",
author = "Christian Ohmann and Rita Banzi and Steve Canham and Serena Battaglia and Mihaela Matei and Christopher Ariyo and Lauren Becnel and Barbara Bierer and Sarion Bowers and Luca Clivio and Monica Dias and Christiane Druml and H{\'e}l{\`e}ne Faure and Martin Fenner and Jose Galvez and Davina Ghersi and Christian Gluud and Trish Groves and Paul Houston and Ghassan Karam and Dipak Kalra and Knowles, {Rachel L} and Karmela Krleža-Jerić and Christine Kubiak and Wolfgang Kuchinke and Rebecca Kush and Ari Lukkarinen and Marques, {Pedro Silverio} and Andrew Newbigging and Jennifer O'Callaghan and Philippe Ravaud and Irene Schl{\"u}nder and Daniel Shanahan and Helmut Sitter and Dylan Spalding and Catrin Tudur-Smith and {van Reusel}, Peter and {van Veen}, Evert-Ben and Visser, {Gerben Rienk} and Julia Wilson and Jacques Demotes-Mainard",
note = "{\circledC} 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.",
year = "2017",
month = "12",
day = "14",
doi = "10.1136/bmjopen-2017-018647",
language = "English",
volume = "7",
pages = "e018647",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group Ltd",
number = "12",

}

RIS

TY - JOUR

T1 - Sharing and reuse of individual participant data from clinical trials

T2 - principles and recommendations

AU - Ohmann, Christian

AU - Banzi, Rita

AU - Canham, Steve

AU - Battaglia, Serena

AU - Matei, Mihaela

AU - Ariyo, Christopher

AU - Becnel, Lauren

AU - Bierer, Barbara

AU - Bowers, Sarion

AU - Clivio, Luca

AU - Dias, Monica

AU - Druml, Christiane

AU - Faure, Hélène

AU - Fenner, Martin

AU - Galvez, Jose

AU - Ghersi, Davina

AU - Gluud, Christian

AU - Groves, Trish

AU - Houston, Paul

AU - Karam, Ghassan

AU - Kalra, Dipak

AU - Knowles, Rachel L

AU - Krleža-Jerić, Karmela

AU - Kubiak, Christine

AU - Kuchinke, Wolfgang

AU - Kush, Rebecca

AU - Lukkarinen, Ari

AU - Marques, Pedro Silverio

AU - Newbigging, Andrew

AU - O'Callaghan, Jennifer

AU - Ravaud, Philippe

AU - Schlünder, Irene

AU - Shanahan, Daniel

AU - Sitter, Helmut

AU - Spalding, Dylan

AU - Tudur-Smith, Catrin

AU - van Reusel, Peter

AU - van Veen, Evert-Ben

AU - Visser, Gerben Rienk

AU - Wilson, Julia

AU - Demotes-Mainard, Jacques

N1 - © 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.

PY - 2017/12/14

Y1 - 2017/12/14

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.

AB - 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.

KW - Journal Article

U2 - 10.1136/bmjopen-2017-018647

DO - 10.1136/bmjopen-2017-018647

M3 - Journal article

VL - 7

SP - e018647

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

ER -

ID: 52188255