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Volumn 21, Issue 7, 2012, Pages 690-696

Increasing scientific standards, independence and transparency in post-authorisation studies: The role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

Author keywords

ENCePP; Guidelines; Independence; Medicines; Pharmacoepidemiology; Regulation; Standards; Transparency

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL STUDY; DATA BASE; FUNDING; MEDICAL DECISION MAKING; MEDICAL SOCIETY; METHODOLOGY; POST AUTHORIZATION STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; REGISTER; RESEARCH; STUDY DESIGN;

EID: 84863556829     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3281     Document Type: Article
Times cited : (20)

References (34)
  • 1
    • 0346234415 scopus 로고    scopus 로고
    • Academic-industrial relationships in the life sciences
    • Blumenthal D. Academic-industrial relationships in the life sciences. N Engl J Med 2003; 349: 2452-2459.
    • (2003) N Engl J Med , vol.349 , pp. 2452-2459
    • Blumenthal, D.1
  • 2
    • 79955466670 scopus 로고    scopus 로고
    • Proton pump inhibitors, fracture risk and selection bias: three studies, same database, two answers
    • de Vries F, van Staa TP, Leufkens HG. Proton pump inhibitors, fracture risk and selection bias: three studies, same database, two answers. Osteoporos Int 2011; 22(5): 1641-2.
    • (2011) Osteoporos Int , vol.22 , Issue.5 , pp. 1641-1642
    • de Vries, F.1    van Staa, T.P.2    Leufkens, H.G.3
  • 3
    • 77956545445 scopus 로고    scopus 로고
    • Oral bisphosphonates and oesophageal cancer
    • Wysowski DK. Oral bisphosphonates and oesophageal cancer. BMJ 2010; 341: c4506.
    • (2010) BMJ , vol.341
    • Wysowski, D.K.1
  • 4
    • 70449633381 scopus 로고    scopus 로고
    • Outcome reporting in industry-sponsored trials of gabapentin for off-label use
    • Swaroop Vedula S, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-1971.
    • (2009) N Engl J Med , vol.361 , pp. 1963-1971
    • Swaroop Vedula, S.1    Bero, L.2    Scherer, R.W.3    Dickersin, K.4
  • 5
    • 0029049462 scopus 로고
    • Epidemiology faces its limits
    • Taubes G, Mann CC. Epidemiology faces its limits. Science 1995; 269: 5221.
    • (1995) Science , vol.269 , pp. 5221
    • Taubes, G.1    Mann, C.C.2
  • 6
    • 84863550710 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6(R1). (1996. Accessed September 2011).
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6(R1). (1996. Accessed September 2011).
  • 7
    • 84863550709 scopus 로고    scopus 로고
    • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. (Accessed July 2011).
    • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. (Accessed July 2011).
  • 8
    • 84863538583 scopus 로고    scopus 로고
    • International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). (2007. Accessed September 2011).
    • International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). (2007. Accessed September 2011).
  • 9
    • 37349032506 scopus 로고    scopus 로고
    • STROBE initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
    • von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology 2007; 18(6): 800-10.
    • (2007) Epidemiology , vol.18 , Issue.6 , pp. 800-810
    • von Elm, E.1    Altman, D.G.2    Egger, M.3    Pocock, S.J.4    Gøtzsche, P.C.5    Vandenbroucke, J.P.6
  • 10
    • 84863538581 scopus 로고    scopus 로고
    • European Risk Management Strategy: 2008-2009 work programme adopted. (2008. Accessed July 2011).
    • European Risk Management Strategy: 2008-2009 work programme adopted. (2008. Accessed July 2011).
  • 11
    • 84863538582 scopus 로고    scopus 로고
    • International Society for Pharmacoepidemiology (ISPE).
    • International Society for Pharmacoepidemiology (ISPE).
  • 12
    • 84863539532 scopus 로고    scopus 로고
    • International Society of Pharmacovigilance (ISOP).
    • International Society of Pharmacovigilance (ISOP).
  • 13
    • 84863545957 scopus 로고    scopus 로고
    • European Federation of Pharmaceutical Industries and Associations (EFPIA).
    • European Federation of Pharmaceutical Industries and Associations (EFPIA).
  • 14
    • 84863545961 scopus 로고    scopus 로고
    • ENCePP Research Resources Database. (Accessed October 2011).
    • ENCePP Research Resources Database. (Accessed October 2011).
  • 15
    • 84863539533 scopus 로고    scopus 로고
    • ENCePP. The ENCePP Code of Conduct. (2010. Accessed October 2011).
    • ENCePP. The ENCePP Code of Conduct. (2010. Accessed October 2011).
  • 16
    • 84863545958 scopus 로고    scopus 로고
    • ENCePP. Checklist for Study Protocols (Revision 1). (2011. Accessed October 2011).
    • ENCePP. Checklist for Study Protocols (Revision 1). (2011. Accessed October 2011).
  • 17
    • 84863539534 scopus 로고    scopus 로고
    • ENCePP. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. (2011. Accessed October 2011).
    • ENCePP. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. (2011. Accessed October 2011).
  • 18
    • 84863550712 scopus 로고    scopus 로고
    • Electronic Register of Studies. (Accessed October 2011).
    • Electronic Register of Studies. (Accessed October 2011).
  • 19
    • 84863539535 scopus 로고    scopus 로고
    • ENCePP Work Plan 2011-2012. (2010. Accessed October 2011).
    • ENCePP Work Plan 2011-2012. (2010. Accessed October 2011).
  • 20
    • 84863545959 scopus 로고    scopus 로고
    • ENCePP Response to: Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions 'A comprehensive approach on personal data protection in the European Union'. (2011, Accessed October 2011).
    • ENCePP Response to: Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions 'A comprehensive approach on personal data protection in the European Union'. (2011, Accessed October 2011).
  • 21
    • 84863538584 scopus 로고    scopus 로고
    • ENCePP Response to: Concept paper of 9 February 2011 submitted for public consultation by the European Commission on the Revision of the 'Clinical Trials Directive' 2001/20/EC. (2011, Accessed August 2011).
    • ENCePP Response to: Concept paper of 9 February 2011 submitted for public consultation by the European Commission on the Revision of the 'Clinical Trials Directive' 2001/20/EC. (2011, Accessed August 2011).
  • 22
    • 84863538585 scopus 로고    scopus 로고
    • ENCePP Working Group 1. Existing guidances. (2010, Accessed September 2011).
    • ENCePP Working Group 1. Existing guidances. (2010, Accessed September 2011).
  • 23
    • 17844372209 scopus 로고    scopus 로고
    • Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
    • Krlea-Jeri K, Chan A-W, Dickersin K, et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). Br Med J 2005; 330: 956-8.
    • (2005) Br Med J , vol.330 , pp. 956-958
    • Krlea-Jeri, K.1    Chan, A.-W.2    Dickersin, K.3
  • 24
    • 77149140781 scopus 로고    scopus 로고
    • Registration of observational studies
    • Loder E, Groves T, MacAuley D. Registration of observational studies. Br Med J 2010; 340: c950.
    • (2010) Br Med J , vol.340
    • Loder, E.1    Groves, T.2    MacAuley, D.3
  • 25
    • 77955919258 scopus 로고    scopus 로고
    • Preregistration of epidemiologic studies: an ill-founded mix of ideas
    • Vandenbroucke JP. Preregistration of epidemiologic studies: an ill-founded mix of ideas. Epidemiology 2010; 21(5): 619-620.
    • (2010) Epidemiology , vol.21 , Issue.5 , pp. 619-620
    • Vandenbroucke, J.P.1
  • 26
    • 80053235713 scopus 로고    scopus 로고
    • Registration of observational studies: perspectives from an industry-based epidemiology group
    • DOI: 10.1002/pds.2221
    • Chavers S, Fife D, Wacholtz M, Stang P, Berlin J. Registration of observational studies: perspectives from an industry-based epidemiology group. Pharmacoepidemiol Drug Saf 2011: 20; 1009-1013. DOI: 10.1002/pds.2221.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , pp. 1009-1013
    • Chavers, S.1    Fife, D.2    Wacholtz, M.3    Stang, P.4    Berlin, J.5
  • 27
    • 79951597867 scopus 로고    scopus 로고
    • Postmarketing studies of drug safety. A European initiative could help bring more transparency and rigour to pharmacoepidemiology
    • Schneeweiss S, Avorn J. Postmarketing studies of drug safety. A European initiative could help bring more transparency and rigour to pharmacoepidemiology. Br Med J 2011; 342: d342.
    • (2011) Br Med J , vol.342
    • Schneeweiss, S.1    Avorn, J.2
  • 28
    • 84863550629 scopus 로고    scopus 로고
    • ENCePP Studies. (Accessed October 2011).
    • ENCePP Studies. (Accessed October 2011).
  • 29
    • 84863539530 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (2001. Accessed August 2011).
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (2001. Accessed August 2011).
  • 30
    • 84863550630 scopus 로고    scopus 로고
    • ENCePP. ENCePP considerations on the definition of non-interventional trials under the current legislative framework ("Clinical Trials Directive" 2001/20/EC). (2011. Accessed November 2011).
    • ENCePP. ENCePP considerations on the definition of non-interventional trials under the current legislative framework ("Clinical Trials Directive" 2001/20/EC). (2011. Accessed November 2011).
  • 31
    • 84863550631 scopus 로고    scopus 로고
    • ENCePP. Minutes of ENCePP Workshop with Medical Journal Editors. (2011, Accessed October 2011).
    • ENCePP. Minutes of ENCePP Workshop with Medical Journal Editors. (2011, Accessed October 2011).
  • 32
    • 84863538580 scopus 로고    scopus 로고
    • Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. (2010. Accessed July 2011).
    • Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. (2010. Accessed July 2011).
  • 33
    • 84863539531 scopus 로고    scopus 로고
    • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (2010. Accessed July 2011).
    • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (2010. Accessed July 2011).
  • 34
    • 80053277574 scopus 로고    scopus 로고
    • European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
    • DOI: 10.1002/pds.2209.
    • Blake KV, Prilla S, Biscaro M, et al. European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf 2011: 20; 1021-1029. DOI: 10.1002/pds.2209.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , pp. 1021-1029
    • Blake, K.V.1    Prilla, S.2    Biscaro, M.3


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