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Points to Consider of Protocol on Multinational Trial

Points to Consider of Protocol on Multinational Trial. Masaaki Kuwahara, Ph.D. Takeda Chemical Industries, Ltd. The 4th Kitasato-Harvard symposium, 2003.10.28. Clinical Study Package of Bridging Studies(1). NDA. NDA. Clinical Study Package of Bridging Studies(2). ？？. NDA. NDA.

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Points to Consider of Protocol on Multinational Trial

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  1. Points to Consider of Protocol on Multinational Trial Masaaki Kuwahara, Ph.D. Takeda Chemical Industries, Ltd. The 4th Kitasato-Harvard symposium, 2003.10.28

  2. Clinical Study Package of Bridging Studies(1) NDA NDA

  3. Clinical Study Package of Bridging Studies(2) ？？ NDA NDA

  4. Challenges in Multinational Trial NDA

  5. Premise of Multinational Trial • Environments for Clinical Trials in Japan • Regulatory requirements • Place of compound on medical treatment • Adequate characterization of pharmacokinetics in the population of relevant region

  6. Target phasesof Multinational Trial Therapeutic Use TherapeuticConfirmatory TherapeuticExploratory HumanPharmacology

  7. Key success factor for Multinational trial • Global data management • Design of trial (protocol, CRF) • Speed of Enrollment • Quality and Quantity of trial • Language

  8. Central Steering Committee IDMC Principal InvestigatorRegional InvestigatorMedical Expert Advisory on issue of Overall Safety and Implementation of Trial Central Trial Control Center Join Central SC about Preparation and Revise of Protocol Decision Making of Schedule and Overall Implementation of Trial Report and Instruction on Decision of Central SC Information Control of Preparation and Revise of Protocol Transfer and Provision of Safety Information, Data of CRF and IB, etc Regional Steering Committee Regional InvestigatorMedical Expert Regional Trial Control Center Safety Information, Dispatch of CRA, Document of Protocol, CRF Collection, Pts Data Sharing, SDV and Preparation of IRB document on Regional Site Trial Site Investigator, CRC Structure of Global development Committee on Multinational Trial

  9. Flexibility of Protocol Design（1） • Primary Objective should be same • Secondary Objective should be same additional item is possible

  10. Flexibility of Protocol Design（2） • Study Population patients diagnosed with similar assessment • Inclusion Criteria main criteria should be same • Exclusion Criteria main criteria should be same

  11. Flexibility of Protocol Design（3） • Washout Period should be similar • Dose and Mode of Administration should be same • Duration of Treatment should be same

  12. Flexibility of Protocol Design（4） • Excluded medication should be similar pharmacological class • Dose and Mode of Active control should be same

  13. Flexibility of Protocol Design（5） • Primary Endpoint should be same • Secondary Endpoint should be same additional item is possible

  14. Flexibility of Protocol Design（6） • Vital signs main items should be same • Clinical Laboratory tests central laboratory should be utilized or main items should be same

  15. Flexibility of Protocol Design（7） • Record adverse events definition, severity, causality should be assessed using same categories • Dropouts and/or End of Study should be assessed using same categories

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