EDP Sciences logo
Authentification abonné
rechercher
Menu
Accueil Tous les numéros Volume 65 / Numéro 4 (Juillet-Août 2010) Therapie, 65 4 (2010) 329-334 Références
Accès gratuit
Numéro
Therapie
Volume 65, Numéro 4, Juillet-Août 2010
Page(s) 329 - 334
Section Méthodologie / Methodology
DOI https://doi.org/10.2515/therapie/2010035
Publié en ligne 21 septembre 2010
  1. EU standard of medicinal product registration: clinical evaluation of risk/benefit – The role of comparator studies. Ref. EMEA/119319/04, October 2004 http://www.ema.europa.eu [Google Scholar]
  2. Van Luijn JCF, Gribnau FWJ, Leufkens HGM. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol 2006; 63: 159-62 [CrossRef] [PubMed] [Google Scholar]
  3. Chalkidou K, Tunis S, Lopert R, Comparative effectiveness research and evidence-based health policy: experience from four countries. The Milbank Quarterly 2009; 87: 339-67 [CrossRef] [PubMed] [Google Scholar]
  4. Clement FM, Harris A, Li JJ, Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 2009; 302: 1437-43 [CrossRef] [PubMed] [Google Scholar]
  5. Marley J. Efficacy, effectiveness, efficiency. Aust Prescr 2000; 23: 114-5 [Google Scholar]
  6. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86-9 [CrossRef] [PubMed] [Google Scholar]
  7. Atkins D. Creating and synthesizing evidence with decision makers in mind. Med Care 2007; 45: S16-S22 [CrossRef] [PubMed] [Google Scholar]
  8. Mitka M. Studies comparing treatments ramp up. JAMA 2009; 301: 1975 [CrossRef] [PubMed] [Google Scholar]
  9. Berwick DM. The science of improvement. JAMA 2008; 299: 1182-4 [CrossRef] [PubMed] [Google Scholar]
  10. Dawson L, Zarin DA, Emanuel EJ, Considering usual medical care in clinical trial design. PLoS Med 2009; 6: 1-6 [PubMed] [Google Scholar]
  11. Rawlins M. Harveian Oration - De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet 2008; 372: 2152–61 [CrossRef] [PubMed] [Google Scholar]
  12. ICH topic E10. Choice of control group in clinical trials. Ref. CPMP/ICH/364/96, January 2001 http://www.ema.europa.eu [Google Scholar]
  13. Glickman SW, McHutchinson JG, Peterson ED, Ethical and scientific implications of the globalisation of clinical research. N Eng J Med 2009; 360: 816-23 [CrossRef] [Google Scholar]
  14. Luce BR, Kramer JM, Goodman SN, Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 2009; 151: 206-9 [PubMed] [Google Scholar]
  15. EMEA/CPMP position statement on the use of placebo in clinical trials with regard to the revised declaration of Helsinki. Ref. EMEA/17424/01, June 2001 http://www.ema.europa.eu [Google Scholar]
  16. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ 2009; 338: 804-6 [CrossRef] [Google Scholar]
  17. Andersson RE, Petzold MG. Nonsurgical treatment of appendiceal abscess or phlegmon: a systematic review and meta-analysis. Ann Surg 2007; 246: 741-8 [CrossRef] [PubMed] [Google Scholar]
  18. http://www.nice.org.uk/aboutnice/scientificadvice/AboutScientificAdvice.jsp [Google Scholar]
  19. http://www.cadth.ca/index.php/en/cdr/filing-submission/pre-submission-meetings [Google Scholar]
  20. Table Ronde n°2 de Giens XXIII. Le bon usage du médicament : définition, référentiels, périmètre et champ d’application. Therapie 2008; 63: 267-73 [Google Scholar]