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

被引:106
|
作者
Ohmann, Christian [1 ]
Banzi, Rita [2 ]
Canham, Steve [3 ]
Battaglia, Serena [4 ]
Matei, Mihaela [4 ]
Ariyo, Christopher [5 ]
Becnel, Lauren [6 ]
Bierer, Barbara [7 ,8 ]
Bowers, Sarion [9 ]
Clivio, Luca [2 ]
Dias, Monica [10 ]
Druml, Christiane [11 ]
Faure, Helene [12 ]
Fenner, Martin [13 ]
Galvez, Jose [14 ]
Ghersi, Davina [15 ]
Gluud, Christian [16 ]
Groves, Trish [17 ]
Houston, Paul [6 ]
Karam, Ghassan [18 ]
Kalra, Dipak [19 ]
Knowles, Rachel L. [20 ]
Krleza-Jeric, Karmela [21 ]
Kubiak, Christine [4 ]
Kuchinke, Wolfgang [22 ]
Kush, Rebecca [23 ]
Lukkarinen, Ari [5 ]
Marques, Pedro Silverio [24 ]
Newbigging, Andrew [25 ,26 ]
O'Callaghan, Jennifer [27 ]
Ravaud, Philippe [28 ]
Schluender, Irene [29 ]
Shanahan, Daniel [12 ,30 ]
Sitter, Helmut [31 ]
Spalding, Dylan [32 ]
Tudur-Smith, Catrin [33 ]
van Reusel, Peter [6 ]
van Veen, Evert-Ben [34 ,35 ]
Visser, Gerben Rienk [36 ]
Wilson, Julia [9 ]
Demotes-Mainard, Jacques [4 ]
机构
[1] ECRIN, Dusseldorf, Germany
[2] IRFMN, IRCCS, Milan, Italy
[3] Canham Informat Syst, Surrey, England
[4] ECRIN, Paris, France
[5] CSC IT Ctr Sci, Espoo, Finland
[6] Clin Data Interchange Stand Consortium, Austin, TX USA
[7] Brigham & Womens Hosp, MRCT Ctr BWH & Harvard, Boston, MA USA
[8] Harvard Univ, Boston, MA USA
[9] Wellcome Trust Sanger Inst, Cambridge, England
[10] European Med Agcy, London, England
[11] Med Univ Vienna, Eth Collect & Hist Med, Vienna, Austria
[12] BioMed Cent, London, England
[13] DataCite, Hannover, NH, Germany
[14] NCI, NIH, Bethesda, MD 20892 USA
[15] Natl Hlth & Med Res Council, Watson, ACT, Australia
[16] Rigshosp, Copenhagen Univ Hosp, Ctr Clin Intervent Res, Copenhagen Trial Unit, Copenhagen, Denmark
[17] BMJ Editorial, BMJ Editorial BMA House, London, England
[18] WHO, Org Mondiale Sante, Geneva, Switzerland
[19] European Inst Innovat Hlth Data, Ghent, Belgium
[20] MRC, London, England
[21] IMPACT, Ottawa Grp, Montreal, PQ, Canada
[22] Heinrich Heine Univ, Coordinat Ctr Clin Trials, Dusseldorf, Germany
[23] Formerly Clin Data Interchange Stand Consortium, Austin, TX USA
[24] EATG, Lisbon, Portugal
[25] TrialGrid Ltd, London, England
[26] Formerly Medidata Solut, Hammersmith, England
[27] Wellcome Trust Res Labs, London, England
[28] INSERM, METHODS Team, UMR S 1153, Paris, France
[29] Biobanking & Biomol Resources Res Infrastruct BBM, Berlin, Germany
[30] Fac 1000, London, England
[31] Philipps Univ, Inst Theoret Surg, Marburg, Germany
[32] EBI, EMBL, Hinxton, England
[33] Univ Liverpool, Dept Biostat, Liverpool, Merseyside, England
[34] MLC Fdn, The Hague, Netherlands
[35] Medlawconsult, The Hague, Netherlands
[36] Trial Data Solut, Amsterdam, Netherlands
来源
BMJ OPEN | 2017年 / 7卷 / 12期
关键词
INTERNATIONAL COMMITTEE; INFORMATION;
D O I
10.1136/bmjopen-2017-018647
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:24
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