How should we plan and conduct Asian studies -from Reviewer’s view pointKazuhiko MORI Pharmaceuticals and Medical Devices Evaluation Center(PMDEC) Standard Disclaimer This views expressed are my personal opinions and not necessarily represent the views or findings of the PMDEC この発表は演者の個人的意見に基づくものであり、医薬品医療機器審査センターとしての見解を示すものではありません From personal experience Increase of inquiries about Asian Study → upsurge of the global company’s interest Hear the news about the construction of the new hospital for clinical trials in China (over 1000 beds institution) Upsurge of APEC members interest Bridging Study boom Why Asian studies? Economical reason(low cost for studies) ～1/10 of Japanese study Highly motivated Investigator(Patient) Good progress on patient recruitment 50～100 cases per facility Less (intrinsic) ethnic difference within Asian Positive impact on Global Development Pros and Cons of Asian Studies ＜Pros＞ Cost saving(low cost patient) Time saving(accelerate development) Avoid (intrinsic) ethnic difference (hope?) ＜Cons＞ Difficult management work(different culture) How to check & keep data integrity Decline of domestic development (?) Points to keep in mind Planning Feasibility Universality (Design, Endpoints, Statistical methods) Conduct ← critical importance GCP compliance Monitoring & Audit Reviewer’s View & Concern Where? → Investigational Site(Hospital) Who? → Investigator, Patient How? → Management, Monitoring etc. Is this data reliable? Worth to evaluate? Seeing is Believing → GCP inspection Overseas GCP inspection Total 32 inspections (1997-2003) 23 for Pharmaceuticals 9 for Medical devices Total 67 hospitals 3 missions to Asian countries USA(18) EU(10) Australia(1) Details of visit by country 3 1 USA EU 10 18 Asia Others Details of visited hospitals by country 6 2 USA EU 22 37 Asia Others Overseas GCP inspection team GCP inspector Medical review officer (Clinician) Review officer 1-day visit / 1-site SDV (CRF ←→ medical record) IRB activity verification Seeing(&Hearing) is Believing Archive inspection medical records, films, charts, receipts Facility review (tour round) pharmacy, storeroom, hospital room etc. Interview Investigator, nurse, pharmacist, technician, IRB members Use of Global data The More…. Clear proof of efficacy Discovery of rare ADR Precise estimation of event rate and seriousness Evaluation of Risk/Benefit valance in various situation of subjects …...etc. Expectation for Global Development Data Amount Quality Increase Variety Potential Risk Decrease Local Development Global Development NDA Review using Asian studies data Benefit Large number and variety of sub-populations Enable to check data robustness/reproducibility Difficulty and/or Potential Risk Need analysis deep into various backgrounds Increase negative information accompany with positive information GCP inspection The future of Asian studies Challenge that lies ahead Coordination between nations, site, investigators Quality of data (ex. long term study) Monitoring & Audit Expectation Low cost/High performance clinical development