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From bench to bedside : making the right question getting the right answers

This article discusses the importance of clinical research in pharmaceutical development and the need for post-marketing studies to evaluate safety, effectiveness, and real-world use of new drugs. It also explores the concept of sharing the risk and highlights the role of the Register of Post-Marketing Use in ensuring appropriate drug use and evaluating efficacy.

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From bench to bedside : making the right question getting the right answers

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  1. Frombenchtobedside: making the right questiongetting the right answers • Carlo Tomino Pharm.D. • IRCCS San Raffaele, Rome

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  3. CLINICAL Research: how we can get there? 3

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  5. We need (for the IMP): • QUALITY data and • PRE-CLINICAL data 5

  6. Than, we can move to the CLINICAL TRIAL 14

  7. PRE- MARKETING 15

  8. www.diahome.org 18

  9. POST-MARKETING 19

  10. After Marketing authorization, we need to study more in depth the new product • Safety problems • Cross reaction • Effectiveness (in the “real world” condition) 20

  11. Post- marketing studies • Post AuthorizationSafetystudy (PASS) • Post-AuthorizationEfficacyStudy (PAES) • Observationalstudy • Real world data (public registries) 21

  12. The Registerof post-marketing use Since the secondhalfof 2005, AIFA (the ItalianMedicinesAgency) authorisedfor the marketing newdrugshighly innovative (and veryexpensive). Fortheiruse, case report formsmustbefilled in, inan appropriate web-basedMonitoringRegisters. 22

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  14. The Register of «post-marketing use» role: increasing the patient’s protection by promoting drugs’ appropriate use 24

  15. verifying the realefficacy and tolerabilityofdrugsregisteredbyshortenedprocesses 25

  16. A cultural revolution… 26

  17. a new concept: ‘Sharing the Risk’ each project’s participant must assume his own responsibilities 27

  18. Cost Sharing, Risk Sharing e Payment by Results Three different procedures for the accountability of the involved actors. 28

  19. Treatment continues - entirely paid by the National Health Service (SSN) Responders First therapy cycle for eligible patients Response’ evaluation Drug Treatment stops Non Responders Agreeements with Companies in order to define percentage to be paid by the National Health Service (SSN) 29

  20. PRE & POST 30

  21. DISCOVERY AND PRE-CLINICAL 31

  22. Fordoingthis, greatcollaborationamongallactors (and BasicResearchers!!!) … IS MANDATORY !!! PTs. EC PI BR CRO Sponsor Gov 32

  23. Thankyou 33

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