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Role of Pharmacoepidemiology in post-marketing Surveillance

Role of Pharmacoepidemiology in post-marketing Surveillance. Nicholas Moore Bordeaux, France. Role of Pharmacoepidemiology in post-marketing Surveillance. 莫尔 教授 法国波尔多第二大学. From Evidence-based medicine to Hope-based Medicine. Drug development. Traditional approach.

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Role of Pharmacoepidemiology in post-marketing Surveillance

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  1. Role of Pharmacoepidemiology in post-marketing Surveillance Nicholas Moore Bordeaux, France Changsha, Nov 30 2010

  2. Role of Pharmacoepidemiology in post-marketing Surveillance 莫尔 教授 法国波尔多第二大学 Changsha, Nov 30 2010

  3. From Evidence-based medicineto Hope-based Medicine Changsha, Nov 30 2010

  4. Drug development Changsha, Nov 30 2010

  5. Traditional approach • Chemists invent new chemical entity • NCE / screen • Biotech • Me too • … Changsha, Nov 30 2010

  6. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Receptors • Animal models Changsha, Nov 30 2010

  7. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Receptors • Animal models • Compared with other drugs • Geared for activity on disease predictors Changsha, Nov 30 2010

  8. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • In animal models • Using preordained (GLP) organs etc... Changsha, Nov 30 2010

  9. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development Changsha, Nov 30 2010

  10. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development • Clinical trials in selected populations • Phase I, II, III Changsha, Nov 30 2010

  11. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development • Marketing authorization (NDA) Changsha, Nov 30 2010

  12. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development • Marketing authorization (NDA) • Mass marketing Changsha, Nov 30 2010

  13. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development • Marketing authorization (NDA) • Mass marketing • Mass Problem Changsha, Nov 30 2010

  14. Traditional approach • Chemists invent new chemical entity • Pharmacologists test it for activity • Toxicologists test it for toxicity • If all goes well • Clinical development • Marketing authorization (NDA) • Massive marketing • Massive Problem • Drug withdrawn/suspended Changsha, Nov 30 2010

  15. Think • Cerivastatin • Rofecoxib • And many others… Changsha, Nov 30 2010

  16. Why? Changsha, Nov 30 2010

  17. We knew all about the drug • Good preclinical studies • Great trials • On carefully selected patients • Without any risk factors • Using the best dose • For the right duration Changsha, Nov 30 2010

  18. We had good meta-analyses • From these good clinical trials • Done according to NICE and Cochrane • Showing • Superior efficacy • Excellent tolerability • Cost-effectiveness Changsha, Nov 30 2010

  19. all the experts were happy And there was all the evidence! Changsha, Nov 30 2010

  20. But • Real life is different from clinical trials • And real drugs are used on real patients with possible real consequences Changsha, Nov 30 2010

  21. Patients can be different in real life than in clinical trials Changsha, Nov 30 2010

  22. Patient selection in trials Changsha, Nov 30 2010

  23. Comparison of data from clinical trials and real life use • Celecoxib : • Simvastatine : Martin K, et al, Differences between clinical trials and post-marketing use, Br J Clin Pharmacol 2004;57:86-92, Changsha, Nov 30 2010

  24. Patient diversity in real life Changsha, Nov 30 2010

  25. Changsha, Nov 30 2010

  26. Use can be different Changsha, Nov 30 2010

  27. Drug trials of COXIBs in OA • Against tNSAIDs (ibuprofen, diclofenac) • Full dose • No gastroprotection • For 6 months to 1 year Changsha, Nov 30 2010

  28. NSAIDs in OA GPRH Study 250 GP/Rh 1000 NSAIDs Users Changsha, Nov 30 2010

  29. NSAIDs in OA Number of treatment days bought over 9 months Changsha, Nov 30 2010

  30. NSAIDs in OA Changsha, Nov 30 2010

  31. Celecoxib: first buyers of 14000 initial prescriptions in December 2000 Changsha, Nov 30 2010

  32. NSAIDs in OA • Only 10 to 25% have more than 2-3 months of treatment per year • What is the meaning of risks (and benefits) estimated from full-time full dose use? Changsha, Nov 30 2010

  33. Clinical trials give real answers • That doesn’t mean they’re useful Changsha, Nov 30 2010

  34. So that EBM should really be HBM Changsha, Nov 30 2010

  35. Hope-based Medicine We hope the results of clinical trials will be duplicated in real life use of the drugs Changsha, Nov 30 2010

  36. How can the applicability of EBM be ensured? Changsha, Nov 30 2010

  37. Pharmacology Study of the effects of drugs (in man) Epidemiology Study of the distributions and determinants of diseases and health in the population Pharmacoepidemiology • Pharmaco-Epidemiology • Use of epidemiological methods to study the distribution and effects of drugs in populations Changsha, Nov 30 2010

  38. Need to understand • What is happening ? • Who has the disease ? • Who is using the drug ? • With what consequences? • Positive • Negative • Financial • … Changsha, Nov 30 2010

  39. Populations Changsha, Nov 30 2010

  40. Treated Population Unduly treated Duly Treated Forbidden Population  Unduly untreated Target Population The different populations Changsha, Nov 30 2010

  41. Treated Population Forbidden Population  Ideally: Duly Treated Target Population Changsha, Nov 30 2010

  42. Treated Population Forbidden Population  Target Population at worst: Unduly treated Unduly untreated Changsha, Nov 30 2010

  43. Treated Population Unduly treated Duly Treated Forbidden Population  Unduly untreated Target Population Most often Changsha, Nov 30 2010

  44. Need to study • Drug exposure • What, when, and for how long, at what dose • Outcomes • And then, what happened? Changsha, Nov 30 2010

  45. Data sources • Ad hoc • Specific studies • Pre-existing • For research: panels, cohorts • Databases : • Clinical (GP, hospitals) • Administrative: insurance systems Changsha, Nov 30 2010

  46. Data sources • The prescriber • Ad hoc studies • databases • The patient • Cohorts • Direct contact/polls • Databases • Health insurance • GP databases • … Changsha, Nov 30 2010

  47. Methodologies Changsha, Nov 30 2010

  48. Methodologies ? Changsha, Nov 30 2010

  49. ? Changsha, Nov 30 2010

  50. Study Methods Present Past Future Changsha, Nov 30 2010

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