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Significance of Extrapolation of Foreign Clinical Data to Asian Countries Masahiro Takeuchi Div. of Biostatistics Kitasato University Graduate School The.

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Presentation on theme: "Significance of Extrapolation of Foreign Clinical Data to Asian Countries Masahiro Takeuchi Div. of Biostatistics Kitasato University Graduate School The."— Presentation transcript:

1 Significance of Extrapolation of Foreign Clinical Data to Asian Countries Masahiro Takeuchi Div. of Biostatistics Kitasato University Graduate School The 2nd Kitasato-Harvard Symposium, 10/22/01

2 Acknowledgment Bridging Study Working Group* Div. of Biostatistics Kitasato University Graduate School Kazuhiro Abe, Isao Kawachi, Masahiro Takeuchi, Masako Nishikawa, Keiichiro Hirose, Yoshiharu Horie, Kazuhiro Matsui

3 Outline Introduction E5 Guideline Application of E5 Guideline from Statistical Point of View Future Application

4 Introduction ICH - General Purpose –Unification of Necessary Documentation and its Formats for NDA Submission ICH - Extrapolation –Avoidance of Unnecessary Clinical Trials Ethically Speaking Globalization –Good Drugs in a Faster Time

5 Conditions for Extrapolation Two factors –Intrinsic Factors –Extrinsic Factors

6 Review of Two Factors (APPENDIX A) Intrinsic Factors –Genetic: race, drug metabolism, genetic diseases –Physiological and pathological conditions: Age ( children-elderly), Liver, Kidney, Cardiovascular functions, Diseases Extrinsic Factors –Culture, Medical Practice, Regulatory practice/GCP, Methodology/Endpoints

7 Implication of Two Factors Intrinsic Factors –Do we have an clearly defined comparative population to targeted/existed foreign population? Extrinsic Factors –Can we conduct a planned clinical trial ?

8 Application of E5 Guideline Target Disease Population Sample US EU US Intrinsic factors No Yes Extrinsic Factors No Yes EU NR Necessary Conditions Necessary Conditions Part I Part II Part III Part IV

9 Application of E5 Guideline: Part I Target Disease Population Sample Clinical Trial (y 1, y 2, …, y n ) Estimation of Efficacy Two Major Concerns: (i) high quality protocol (ii) high quality of data Regulatory review system GCP

10 Application of E5 Guideline: Part II Intrinsic Factors No EUUSNR Sample from EU Sample from US Sample from NR (y EU1, y EU2, …, y EUn1 ) (y US1, y US2, …, y USn2 ) (y NR1, y NR2, …, y NRn3 ) Sample from a Same Probability Space Genetic variation

11 Application of E5 Guideline: Part III Intrinsic Factors EU NR US Yes Question: Are these samples (EU, US, and NR) derived from a same target disease population? Answer: No Need adjustment for intrinsic factors to have a common population among three regions Genetic variation

12 Application of E5 Guideline: Part IV Extrinsic Factors NoYes Necessary conditions Quality Control - Protocol Review System - GCP Safety Issues - surveillance Conduct of suitable clinical trials subject to medical practice, clinical trial environment Study Design - placebo vs active - choice of endpoint Language& culture - subsets of primary endpoint

13 Future Application: Past Experience Western Data Region 1Region 2Region 3 (i) No clear scientific evidence regarding racial difference (ii) No clear statistical approach - similarity, sample size (iii) No unified regulatory authority requirements Bridging Study 1Bridging Study 2Bridging Study 3

14 (i) Scientific Evidence NEJM - Two drugs in heart failure May 3, 2001 - Two editorials Importance of pharmacogenomics (ii) Statistical Evidence Shih ､ Lui - Consistency among trials Ware, Morris - Empirical Bayes Akahira and Takahashi, Takeuchi - Consistency by bootstrap Homogeneous target population Clear definition of efficacy Statistical approach/Sample size (iii) Regulatory Requirements APEC Meeting in Taiwan in May,01 Quality control of trials - Regulatory review system - GCP

15 Future Application Western Data Similar regions Region 1Region 2Region 3 Similar region: - Intrinsic factors - Extrinsic factors (medical practice, clinical trial environment,etc) - GCP

16 Future Challenge EU US Asia (i) one global protocol - def. of target population - def. of expected efficacy - study design (ii) modification subject to - intrinsic factors - extrinsic factors (iii) quality control of trials - protocol review - GCP Clear def. of probability space Target Disease Pop. Each sample derived from the PS Quality assurance

17 Good Drugs in a Faster Time Correctly Targeted Disease Population Thoroughly Planned and Collected Sample High Quality Data

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