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How should we plan and conduct Asian studies -from Reviewer ’ s view point-

How should we plan and conduct Asian studies -from Reviewer ’ s view point-. Kazuhiko 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

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How should we plan and conduct Asian studies -from Reviewer ’ s view point-

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  1. How should we plan and conduct Asian studies -from Reviewer’s view point- Kazuhiko MORI Pharmaceuticals and Medical Devices Evaluation Center(PMDEC)

  2. 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

  3. 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

  4. 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

  5. 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 (?)

  6. Points to keep in mind • Planning • Feasibility • Universality (Design, Endpoints, Statistical methods) • Conduct ← critical importance • GCP compliance • Monitoring & Audit

  7. 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

  8. 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)

  9. Details of visit by country

  10. Details of visited hospitals by country

  11. Overseas GCP inspection team • GCP inspector • Medical review officer (Clinician) • Review officer 1-day visit / 1-site SDV (CRF ←→ medical record) IRB activity verification

  12. 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

  13. 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.

  14. Expectation for Global Development Data Amount Quality Variety Increase Potential Risk Decrease Local Development Global Development

  15. 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

  16. 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

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