메뉴 건너뛰기




Volumn 16, Issue 6, 2013, Pages 322-335

Clinical trial transparency and orphan drug development: Recent trends in data sharing by the pharmaceutical industry

Author keywords

Clinical trial; Data sharing; European Medicines Agency; GlaxoSmithKline; Medtronic; Orphan drug; Rare disease; Roche; Transparency

Indexed keywords

ORPHAN DRUG; OSELTAMIVIR; PAROXETINE; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; ROSIGLITAZONE;

EID: 84899964307     PISSN: 16624246     EISSN: 16628063     Source Type: Journal    
DOI: 10.1159/000355941     Document Type: Article
Times cited : (12)

References (73)
  • 1
    • 84928252878 scopus 로고    scopus 로고
    • An act to amend the public health service act to establish an office of rare diseases at the national institutes of health, and for other purposes, Pub. L. No
    • Nov 6
    • An Act to amend the public health service act to establish an office of rare diseases at the national institutes of health, and for other purposes, Pub. L. No. 107-280, 116 Stat. 1988-1991 [2002 Nov 6]
    • (2002) Stat. , vol.116 , pp. 1988-1991
  • 2
    • 84928266250 scopus 로고    scopus 로고
    • European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products
    • European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products. Official Journal L 18 of 22.1.2000.
    • Official Journal L 18 of 22.1.2000
  • 3
    • 84928240587 scopus 로고    scopus 로고
    • Prevalence of rare diseases: Bibliographic data
    • Kremp O (ed)
    • Marpillat N: Prevalence of rare diseases: bibliographic data; in Kremp O (ed): Orphanet Report Series. Orphanet 2012.
    • (2012) Orphanet Report Series. Orphanet
    • Marpillat, N.1
  • 4
    • 84893336201 scopus 로고    scopus 로고
    • Rare and orphan diseases challenges: Clinical development and clinical practice
    • Cassino C, Orfali M, Charnigo RJ, Marsden DL: Rare and orphan diseases challenges: clinical development and clinical practice. J Rare Disorders 2013; 1: 1-3.
    • (2013) J Rare Disorders , vol.1 , pp. 1-3
    • Cassino, C.1    Orfali, M.2    Charnigo, R.J.3    Marsden, D.L.4
  • 7
    • 84859326107 scopus 로고    scopus 로고
    • Rare diseases and orphan drugs
    • Melnikova I: Rare diseases and orphan drugs. Nat Rev Drug Discov 2012; 11: 267-268.
    • (2012) Nat Rev Drug Discov , vol.11 , pp. 267-268
    • Melnikova, I.1
  • 8
    • 84875681788 scopus 로고    scopus 로고
    • Ushering in a new era of open science through data sharing: The wall must come down
    • Ross JS, Krumholz HM: Ushering in a new era of open science through data sharing: the wall must come down. JAMA 2013; 309: 1355-1356.
    • (2013) JAMA , vol.309 , pp. 1355-1356
    • Ross, J.S.1    Krumholz, H.M.2
  • 9
    • 84875452155 scopus 로고    scopus 로고
    • Europe. Drug watchdog ponders how to open clinical trial data vault
    • Rabesandratana T: Europe. Drug watchdog ponders how to open clinical trial data vault. Science 2013; 339: 1369-1370.
    • (2013) Science , vol.339 , pp. 1369-1370
    • Rabesandratana, T.1
  • 11
    • 84869840374 scopus 로고    scopus 로고
    • Glaxo opens door to data on research
    • Oct 11, Sect. B
    • Thomas K: Glaxo opens door to data on research. New York Times, Oct 11, 2012, Sect. B:1.
    • (2012) New York Times , pp. 1
    • Thomas, K.1
  • 14
    • 70349636711 scopus 로고    scopus 로고
    • Trial publication after registration in ClinicalTrials gov: A cross-sectional analysis
    • Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM: Trial publication after registration in ClinicalTrials.gov: a cross-sectional analysis. PLoS Med 2009; 6:e1000144.
    • (2009) PLoS Med , vol.6 , pp. e1000144
    • Ross, J.S.1    Mulvey, G.K.2    Hines, E.M.3    Nissen, S.E.4    Krumholz, H.M.5
  • 16
    • 84884581062 scopus 로고    scopus 로고
    • accessed June 27, 2013
    • European Medicines Agency: publication and access to clinical-trial data. http://www.ema. europa.eu/docs/en-GB/document-library/ Other/2013/06/WC500144730.pdf (accessed June 27, 2013).
    • Publication and Access to Clinical-trial Data
  • 17
    • 0003802728 scopus 로고    scopus 로고
    • Seoul, World Medical Association (accessed June 25, 2013)
    • World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Seoul, World Medical Association, 2008. http:// www.wma.net/en/30publications/10policies/ b3/17c.pdf (accessed June 25, 2013).
    • (2008) Ethical Principles for Medical Research Involving Human Subjects
  • 18
    • 0003802728 scopus 로고    scopus 로고
    • Tokyo, World Medical Association (accessed July 8, 2013)
    • World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Tokyo, World Medical Association, 2013. http:// www.wma.net/fr/20activities/10ethics/10helsinki/ 15publicconsult/DoH-draft-for-public-consultation-annotated.pdf (accessed July 8, 2013).
    • (2013) Ethical Principles for Medical Research Involving Human Subjects
  • 20
    • 84928240584 scopus 로고    scopus 로고
    • Washington, DC, Science Magazine, (accessed May 29, 2013)
    • Couzin-Frankel J: European court wants drug data kept secret. Washington, DC, Science Magazine, 2013. http://news.sciencemag.org/scienceinsider/2013/04/european-courtwants-drug-data-k.html (accessed May 29, 2013).
    • (2013) European Court Wants Drug Data Kept Secret
    • Couzin-Frankel, J.1
  • 24
    • 84879176717 scopus 로고    scopus 로고
    • The changing structure of industry-sponsored clinical research: Pioneering data sharing and transparency
    • Kuntz RE: The changing structure of industry-sponsored clinical research: pioneering data sharing and transparency. Ann Intern Med 2013; 158: 914-915.
    • (2013) Ann Intern Med , vol.158 , pp. 914-915
    • Kuntz, R.E.1
  • 25
    • 84928240581 scopus 로고    scopus 로고
    • accessed July 8, 2013
    • International Rare Diseases Research Consortium (IRDiRC): c2013. http://www.irdirc. org/ (accessed July 8, 2013).
    • (2013)
  • 30
    • 84879165716 scopus 로고    scopus 로고
    • Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: A meta-analysis of individualparticipant data
    • Simmonds MC, Brown JVE, Heirs MK, Higgins JPT, Mannion RJ, Rodgers MA, Stewart LA: Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individualparticipant data. Ann Intern Med 2013; 158: 877-889.
    • (2013) Ann Intern Med , vol.158 , pp. 877-889
    • Simmonds, M.C.1    Brown, J.V.E.2    Heirs, M.K.3    Higgins, J.P.T.4    Mannion, R.J.5    Rodgers, M.A.6    Stewart, L.A.7
  • 31
    • 84879177790 scopus 로고    scopus 로고
    • Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: A systematic review and meta-analysis
    • Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, Helfand M: Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med 2013; 158: 890-902.
    • (2013) Ann Intern Med , vol.158 , pp. 890-902
    • Fu, R.1    Selph, S.2    McDonagh, M.3    Peterson, K.4    Tiwari, A.5    Chou, R.6    Helfand, M.7
  • 32
    • 84928240580 scopus 로고    scopus 로고
    • accessed June 25, 2013
    • Genetic Alliance: Genetic alliance announces registries for all. 2013. http://www.geneticalliance. org/pr.reg4all (accessed June 25, 2013).
    • (2013) Genetic Alliance Announces Registries for All
  • 34
    • 69849092717 scopus 로고    scopus 로고
    • Comparison of registered and published primary outcomes in randomized controlled trials
    • Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P: Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977-984.
    • (2009) JAMA , vol.302 , pp. 977-984
    • Mathieu, S.1    Boutron, I.2    Moher, D.3    Altman, D.G.4    Ravaud, P.5
  • 35
    • 84859005251 scopus 로고    scopus 로고
    • Compliance with mandatory reporting of clinical trial results on clinicaltrials
    • Prayle AP, Hurley MN, Smyth AR: Compliance with mandatory reporting of clinical trial results on clinicaltrials.gov: cross sectional study. BMJ 2012; 344:d7373.
    • (2012) Gov: Cross Sectional Study. BMJ , vol.344 , pp. d7373
    • Prayle, A.P.1    Hurley, M.N.2    Smyth, A.R.3
  • 37
    • 12344297043 scopus 로고    scopus 로고
    • Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents
    • Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Official Journal of the European Communities. 2001;L(145):43-48.
    • (2001) Official Journal of the European Communities , vol.50 , Issue.145 , pp. 43-48
  • 39
    • 84874893971 scopus 로고    scopus 로고
    • The first 2 years of the European Medicines Agency's policy on access to documents: Secret no longer
    • Doshi P, Jefferson T: The first 2 years of the European Medicines Agency's policy on access to documents: secret no longer. JAMA Intern Med 2013; 173: 380-382.
    • (2013) JAMA Intern Med , vol.173 , pp. 380-382
    • Doshi, P.1    Jefferson, T.2
  • 41
    • 84928240578 scopus 로고    scopus 로고
    • Action brought on 17 January 2013-AbbVie e.A. V EMA
    • Action brought on 17 January 2013-AbbVie e.a. v EMA. Official Journal of the European Union. 2013;C(79):26-27.
    • (2013) Official Journal of the European Union. , vol.100 , Issue.79 , pp. 26-27
  • 42
    • 84928240577 scopus 로고    scopus 로고
    • Action brought on 11 February 2013-Inter-Mune UK and others v EMA
    • Action brought on 11 February 2013-Inter-Mune UK and others v EMA. Official Journal of the European Union. 2013;C(114):38.
    • (2013) Official Journal of the European Union. , vol.100 , Issue.114 , pp. 38
  • 46
    • 84928234232 scopus 로고    scopus 로고
    • Nature Publishing Group (accessed June 21, 2013)
    • Cressey D: Clinical-trial transparency hits judicial roadblock, Nature Publishing Group. 2013. http://blogs.nature.com/news/2013/05/ clinical-trial-transparency-hits-judicialroadblock. html (accessed June 21, 2013).
    • (2013) Clinical-trial Transparency Hits Judicial Roadblock
    • Cressey, D.1
  • 48
    • 84908872036 scopus 로고    scopus 로고
    • Clinical data: Time for new approach
    • Rasi G: Clinical data: time for new approach. Financial Times http://www.ft.com/intl/ cms/s/0/5c769724-adcb-11e2-82b8-00144feabdc0. html.
    • Financial Times
    • Rasi, G.1
  • 50
    • 84869835629 scopus 로고    scopus 로고
    • The new BMJ policy on sharing data from drug and device trials
    • Godlee F, Groves T: The new BMJ policy on sharing data from drug and device trials. BMJ 2012; 345:e7888.
    • (2012) BMJ , vol.345 , pp. e7888
    • Godlee, F.1    Groves, T.2
  • 53
    • 84928233610 scopus 로고    scopus 로고
    • accessed July 4
    • GlaxoSmithKline: Clinical study register. http://www.gsk-clinicalstudyregister.com/ (accessed July 4, 2013).
    • (2013) Clinical Study Register
  • 54
    • 84928240572 scopus 로고    scopus 로고
    • accessed June 25, 2013
    • The Association of the British Pharmaceutical Industry (ABPI): ABPI statement on GSK signing up to the Alltrials campaign. 2013. http://www.abpi.org.uk/media-centre/newsreleases/ 2013/Pages/050213-b.aspx (accessed June 25, 2013).
    • (2013) ABPI Statement on GSK Signing Up to the Alltrials Campaign
  • 56
    • 84928240571 scopus 로고    scopus 로고
    • Nature Publishing Group (accessed July 3, 2013)
    • Butler D: GlaxoSmithKline goes public with malaria data, Nature Publishing Group. 2010. http://www.nature.com/news/2010/100120/ full/news.2010.20.html (accessed July 3, 2013).
    • (2010) GlaxoSmithKline Goes Public with Malaria Data
    • Butler, D.1
  • 58
    • 84928240570 scopus 로고    scopus 로고
    • Tamiflu cost us €424m yet we still don't know much about it
    • accessed June 27, 2013
    • Jefferson T: Tamiflu cost us €424m yet we still don't know much about it. All Trials Registered, All Results Reported. 2013. http://www. alltrials.net/news/tamiflu-cost-us-424m-yetwe-still-dont-know-much-about-it/ (accessed June 27, 2013).
    • (2013) All Trials Registered, All Results Reported
    • Jefferson, T.1
  • 60
  • 62
    • 84878215148 scopus 로고    scopus 로고
    • Roche offers researchers access to all Tamiflu trials
    • Cohen D: Roche offers researchers access to all Tamiflu trials. BMJ 2013; 346:f2157.
    • (2013) BMJ , vol.346 , pp. f2157
    • Cohen, D.1
  • 64
    • 84928240569 scopus 로고    scopus 로고
    • Associated Press. (accessed July 3, 2013)
    • Bloomberg Businessweek: Medtronic slips after infuse reviews detailed. Associated Press. 2013. http://www.businessweek.com/ ap/2013-06-18/medtronic-slips-after-infusereviews-detailed (accessed July 3, 2013).
    • (2013) Medtronic Slips after Infuse Reviews Detailed
  • 66
    • 79959950769 scopus 로고    scopus 로고
    • A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned
    • Carragee EJ, Hurwitz EL, Weiner BK: A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J 2011; 11: 471-491.
    • (2011) Spine J , vol.11 , pp. 471-491
    • Carragee, E.J.1    Hurwitz, E.L.2    Weiner, B.K.3
  • 68
    • 33947715604 scopus 로고    scopus 로고
    • Reproducible research: Moving toward research the public can really trust
    • Laine C, Goodman SN, Griswold ME, Sox HC: Reproducible research: moving toward research the public can really trust. Ann Intern Med 2007; 146: 450-453.
    • (2007) Ann Intern Med , vol.146 , pp. 450-453
    • Laine, C.1    Goodman, S.N.2    Griswold, M.E.3    Sox, H.C.4
  • 69
    • 84928240566 scopus 로고    scopus 로고
    • Rare disease day
    • accessed June 27, 2013
    • Terry S: Rare disease day. Baby's first test. 2013. http://www.babysfirsttest.org/newborn-screening/blog/rare-disease-day (accessed June 27, 2013).
    • (2013) Baby's First Test.
    • Terry, S.1
  • 70
    • 84872660761 scopus 로고    scopus 로고
    • accessed June 27
    • U.S. Food and Drug Administration: Search orphan designations and approvals. http:// www.accessdata.fda.gov/scripts/opdlisting/ oopd/ (accessed June 27, 2013).
    • (2013) Search Orphan Designations and Approvals
  • 72
    • 84928240563 scopus 로고    scopus 로고
    • accessed June 26, 2013
    • GlaxoSmithKline: Data sharing agreement. 2013. https://clinicalstudydata.gsk.com/Documents/ DATA%20SHARING%20AGREEMENT% 20TEMPLATE%20for%20PATIENT% 20LEVEL%20DATA%20ACCESS% 20docx.pdf (accessed June 26, 2013).
    • (2013) Data Sharing Agreement
    • GlaxoSmithKline1
  • 73
    • 84928238615 scopus 로고    scopus 로고
    • accessed June 26, 2013
    • GlaxoSmithKline: GSK Clinical Study Requests. 2013. https://clinicalstudydata.gsk. com/ (accessed June 26, 2013).
    • (2013) GSK Clinical Study Requests


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.