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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- 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 • 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)
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 Variety Increase 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