Sharing data from clinical trials: The rationale for a controlled access approach

Trials

Volumn 16, Issue 1, 2015, Pages

  Sydes, Matthew R ^a   Johnson, Anthony L ^a   Meredith, Sarah K ^a   Rauchenberger, Mary ^a   South, Annabelle ^a   Parmar, Mahesh ^a  

^a MEDICAL RESEARCH COUNCIL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; MOTIVATION; PATENT; POLICY; RESPONSIBILITY; RISK ASSESSMENT; SKILL; ACCESS TO INFORMATION; ANONYMIZATION; COOPERATION; FACTUAL DATABASE; INFORMATION DISSEMINATION; INFORMED CONSENT; MANAGEMENT; METHODOLOGY; PROCEDURES;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; DATA ANONYMIZATION; DATABASES, FACTUAL; DISCLOSURE; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; POLICY MAKING; RESEARCH DESIGN;

EID: 84925293794     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0604-6     Document Type: Article

References (27)

1. Academy of Medical Sciences. Clinical trials data sharing: science, privacy and ethics 2013. http://www.acmedsci.ac.uk/viewFile/535a3c3962a46.pdf. Accessed 14 July 2014.
2. Association of the British Pharmaceutical Industry (ABPI). Clinical trial transparency: technical standards for data sharing for old, current and future clinical trials. 2014. http://www.abpi.org.uk/our-work/library/industry/Pages/Workshop-2-Clinical-Trial-Transparency-Technical-standards-for-data-sharing-for-old,-current-and-future-clinical-trials.aspx.
3. Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. BMJ. 2012;345:e7888.
4. Cancer Research UK. Cancer research UK policy on data sharing and preservation. 2009. http://www.cancerresearchuk.org/funding-for-researchers/applying-for-funding/policies-that-affect-your-grant/submission-of-a-data-sharing-and-preservation-strategy/data-sharing-guidelines. Accessed 14 July 2014.
5. European Medicines Agency. Publication and access to clinical-trial data. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf Accessed 14 July 2014.
6. European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA). Principles for responsible clinical trial data sharing: our commitment to patients and researchers. 2013. http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf.
7. Food and Drug Administration. Availability of masked and de-identified non-summary safety and efficacy data; request for comments. 2013. https://www.federalregister.gov/articles/2013/06/04/2013-13083/availability-of-masked-and-de-identified-non-summary-safety-and-efficacy-data-request-for-comments#page-33421. Accessed 14 July 2014.
8. Institute of Medicine. Discussion framework for clinical trial data sharing: guiding principles, elements, and activities. London: The National Academies Press; 2014.
9. Medical Research Council. MRC policy and guidance on sharing of research data from population and patient studies 2012. http://www.mrc.ac.uk/news-events/publications/mrc-policy-and-guidance-on-sharing-of-research-data-from-population-and-patient-studies/. Accessed 14 July 2014.
10. National Cancer Research Institute (NCRI). NCRI data sharing policy. 2006. http://www.casimir.org.uk/storyfiles/64.0.data_sharing_policyapr2006.pdf.
11. Public Library Of Science (PLOS). PLOS editorial and publishing policies: 7. Sharing of data, materials, and software. 2014. http://www.plosone.org/static/policies#sharing. Accessed 16 July 2014.
12. Hughes S, Wells K, McSorley P, Freeman A. Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach. Pharm Stat. 2014;13(3):179-83.
13. Wellcome Trust. Developing a strategy for clinical trial transparency 2013. http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_peda/documents/web_document/WTP054738.pdf. Accessed 16 July 2014.
14. Rumbold B, Lewis G, Bardsley M. Understanding information governance: access to person-level data in health care. In: Nuffield trust. 2011.
15. Clarke S, Weale A. Information governance in health: an analysis of the social values involved in data linkage studies. In: Nuffield trust. 2011.
16. Royal College of General Practitioners (RCGP), Record Access Collaborative. Enabling patients to access electronic health records guidance for health professionals (Version 1.0). London: Royal College of General Practitioners (RCGP); 2010.
17. Drug Information Association. DIA conference to provide expert guidance on evolving electronic data management and submission processes. http://www.diahome.org/en-GB/Press-Releases/2013-09-27-EDM-eSubs.aspx. Accessed 20 July 2014.
18. Banzi R, Bertele V, Demotes-Mainard J, Garattini S, Gluud C, Kubiak C. et al. Fostering EMA's transparency policy. Eur J Int Med. 2014;25:681-4.
19. Institute of Medicine (IOM) Committee on Strategies for Responsible Sharing of Clinical Trial Data, editor. Sharing clinical trials data: maximizing benefits, minimizing risks. Washington DC, USA: National Academies Press; 2015.
20. Drazen JM. Sharing individual patient data from clinical trials. N Engl J Med. 2015;372(3):201-2.
21. Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA: the journal of the American Medical Association. 2015 Feb 24;313(8):793-4.PubMed PMID: 25594500.
22. European Medicines Agency. European medicines agency policy on publication of clinical data for medicinal products for human use. London; 2014-10.
23. Tarran B. Data and privacy: now you see me. Significance. 2014;11(4):10-5.
24. MRC CTU at UCL. 2014. www.ctu.mrc.ac.uk. Accessed 16 July 2014.
25. Gargon E, Williamson PR, Altman DG, Blazeby JM, Clarke M. The COMET Initiative database: progress and activities from 2011 to 2013. Trials. 2014;15(1):279.
26. CSDR: Clinical Study Data Request. https://clinicalstudydatarequest.com/.
27. Strom BL, Buyse M, Hughes J, Knoppers BM. Data sharing, year 1-access to data from industry-sponsored clinical trials. New Engl J Med. 2014;371(22):2052-4. PubMed PMID: 25317745