Accès gratuit
Numéro
Therapie
Volume 68, Numéro 4, Juillet-Août 2013
XXVIIIes Rencontres Nationales de Pharmacologie et Recherche Clinique, Innovation et Évaluation des Technologies de Santé, Tables rondes GIENS – 7 au 9 octobre 2012
Page(s) 217 - 223
DOI https://doi.org/10.2515/therapie/2013040
Publié en ligne 28 août 2013
  1. ICH. Guideline for good clinical practice E6 (R1), 1996. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf [Google Scholar]
  2. Näslund U, Gript L, Fischer-Hansen J, et al. The impact of an end-point committee in a large multicenter, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points. Eur Heart J 1999; 20(10): 771-7 [CrossRef] [PubMed] [Google Scholar]
  3. Heagerty A, Deverly A, Palmer C, et al. The role of the critical event committee in a major cardiovascular outcome study. Blood Press 2002; 11(6): 339-44 [CrossRef] [PubMed] [Google Scholar]
  4. Mahaffey KW, Roe MT, Dyke CK, et al. Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial. Am Heart J 2002; 143(2): 242-8 [CrossRef] [PubMed] [Google Scholar]
  5. Proposition de règlement du Parlement européen et du Conseil relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE. 2012. http://www.senat.fr/europe/textes_europeens/e7534.pdf [Google Scholar]
  6. Strom BL, Kimmel SE, Hennessy S. Pharmacoepidemiology. Fifth edition. Oxford (UK): John Wiley & Sons 2012 [Google Scholar]
  7. European Medicines Agency. Guideline on missing data in confirmatory clinical trials. EMA/CPMP/EWP/1776/99 Rev. 1, 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf [Google Scholar]
  8. European Medicines Agency. The European Network of Centres for Pharmaco-epidemiology and Pharmacovigilance (ENCePP). Guide on methodological standards in pharmacoepidemiology (Revision 1). 2012 EMA/95098/2010. http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideofMethStandardsinPE.pdf [Google Scholar]
  9. International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices. ISPE. Revision: April 2007. http://www.pharmacoepi.org/resources/guidelines_08027.cfm [Google Scholar]
  10. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems. EMA/541760/2011. 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf [Google Scholar]
  11. European Medicines Agency. ICH Topic E 6 (R1) CPMP/ICH/135/95. EMEA London. Guideline for Good Clinical Practice. 2002. http://www.edctp.org/fileadmin/documents/EMEA_ICH-GCP_Guidelines_July_2002.pdf [Google Scholar]
  12. Directive 2001/20/EC. Official Journal of the European Communities, L121/34, Luxembourg. 2001. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF [Google Scholar]
  13. Ohmann C, Kuchinke W, Canham S, et al. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials 2011; 22(12): 85 [CrossRef] [Google Scholar]
  14. Hall GC, Sauer B, Bourke A, et al. Guidelines for good database selection and use in pharmacoepidemiology research. Pharmacoepidemiol Drug Saf 2012; 21(1): 1-10 [CrossRef] [Google Scholar]
  15. GPS – Good practice in secondary data analysis: revision after fundamental reworking. Version 2, January 2008. http://dgepi.de/fileadmin/pdf/leitlinien/gps-version2-final_ENG.pdf [Google Scholar]
  16. The ISPOR good research practices for retrospective database analysis task force report – Part II. Value in Health 2009; 12(8): 1053-61. http://www.ispor.org/TaskForces/documents/RDPartII.pdf [Google Scholar]
  17. Benchimol EI, Manuel DG, To T, et al. Development and use of reporting guidelines for assessing the quality of validation studies of health administrative data. J Clin Epidemiol 2011; 64(8): 821-9 [CrossRef] [PubMed] [Google Scholar]
  18. Van Walraven C, Bennett C, Forster AJ. Administrative database research infrequently used validated diagnostic or procedural codes. J Clin Epidemiol 2011; 64(10): 1054-9 [CrossRef] [PubMed] [Google Scholar]
  19. De Coster C, Quan H, Finlayson A, et al. Identifying priorities in methodological research using ICD-9-CM and ICD-10 administrative data: report from an international consortium. BMC Health Serv Res 2006; 15 (6): 77 [CrossRef] [Google Scholar]
  20. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 2005; 58(4): 323-37 [CrossRef] [PubMed] [Google Scholar]
  21. Lindquist M. Data quality management in pharmacovigilance. Drug Saf 2004; 27(12): 857-70 [CrossRef] [PubMed] [Google Scholar]