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What Impact Will Globalization Have on Bridging Studies

What Impact Will Globalization Have on Bridging Studies. Katsuyoshi Shimatani J-Clin, Pfizer. Number of Consultation for Bridging Studies. Successful cases: >20. Kikoh Mr. Mori (07 October 2001). Drug Approved Through the Use of Overseas Data (1). (NCE). Year. Number of Approvals.

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What Impact Will Globalization Have on Bridging Studies

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  1. What Impact Will Globalization Have on Bridging Studies Katsuyoshi Shimatani J-Clin, Pfizer K. Shimatani/ K-H Symposium/ October 22-23, 2001

  2. Number of Consultation for Bridging Studies Successful cases: >20 Kikoh Mr. Mori (07 October 2001) K. Shimatani/ K-H Symposium/ October 22-23, 2001

  3. Drug Approved Through the Use of Overseas Data (1) (NCE) K. Shimatani/ K-H Symposium/ October 22-23, 2001

  4. Year Number of Approvals Approvals with Overseas Data Total Evaluation Reference 1999 39 3 (7.7%) 2 (5.1%) 1 (2.6%) 2000 39 4 (10.3%) 3 (7.7%) 1 (2.6%) 2001* 13 4 (25%) 2 (8.3%) 2 (16.7%) Total 91 11 (11.1%) 7 (6.6%) 4 (4.4%) Drug Approved Through the Use of Overseas Data (2) (NCE) *: as of October 1 K. Shimatani/ K-H Symposium/ October 22-23, 2001

  5. Was study duplication minimized? Were the objectives of the bridging study achieved? Studies not done in Japan for CCDP Phase II: 1 Phase III: 5 Long term study: 3 Special study: 3 K. Shimatani/ K-H Symposium/ October 22-23, 2001

  6. Time difference of approval between J and W Erectile dysfunction: 11 M Alzheimer’s disease: 36 M Influenza: 15 M Allergy: 55 M Breast cancer: 65 M Migraine: 111 M, 52 M Average 49 M • Was the time-lag (drug-lag) between J and W reduced? Were the objectives of the bridging study achieved? K. Shimatani/ K-H Symposium/ October 22-23, 2001

  7. Are 20 successful consultations and 11 approval drugs in 3 years sufficient numbers? Observations in Bridging Studies (1) • The drug-lag has shortened but has not disappeared • “Bridging” is broadly defined Would it be better to define bridging more narrowly? • Most of the drugs that have been approved are ones that meet special medical needs K. Shimatani/ K-H Symposium/ October 22-23, 2001

  8. Dosage differences Observations in Bridging Studies (2) • There are no set results for determining dosage in bridging studies • Should dose response studies be conducted using the same dosage range as that used in the West, or a dosage range that is one step lower? • Japan is said to use lower dosages than the West, but is it really that the dosages are scientifically low, or is this simply a matter of culture/ custom? K. Shimatani/ K-H Symposium/ October 22-23, 2001

  9. Bridging is intended to mainly pursue similarity only, but has it been possible to adequately obtain the information required for Japanese prescribers and patients? Observations in Bridging Studies (3) • Is it necessary to re-confirm efficacy of the drugs in Japanese? • There are a lot of cases in which extrinsic factors have been a bigger problem than intrinsic factors K. Shimatani/ K-H Symposium/ October 22-23, 2001

  10. There are therapeutic areas for which bridging is difficult • The use of placebo in psychiatry • It is necessary to have a large sample size in order to calculate the true end points in CV area Observations in Bridging Studies (4) • Conducting only 1 bridging study is very risky. Depending on the therapeutic area, reproducibility may be low. Wise way to use overseas data should be considered in order to reduce duplication K. Shimatani/ K-H Symposium/ October 22-23, 2001

  11. 1. Drugs for which it would be difficult to obtain approval based only on the Japanese data have been approved through the use of overseas data 2. The duplication of clinical data has been minimized through the use of overseas data 3. The time required for development has been reduced Bridging Study Benefits With the introduction of the new GCP 4. The quality of Japanese clinical studies has improved 5. Awareness of clinical studies has improved among investigators, sponsors, and others K. Shimatani/ K-H Symposium/ October 22-23, 2001

  12. Bridging Study Transitions Prospective bridging The design and conduction of new studies in Japan that are similar to studies already conducted in the West Retrospective bridging The bridging of similar aspects based on studies already conducted or underway in the West and Japan Advanced bridging The design and conduction of new studies in both the West and Japan for the purpose of bridging K. Shimatani/ K-H Symposium/ October 22-23, 2001

  13. Future options of clinical trials under Globalization 1. Advanced bridging studies 2. Global studies K. Shimatani/ K-H Symposium/ October 22-23, 2001

  14. Advanced Bridging Studies (1) ( 1 ) Protocols of overseas studies should be designed aiming to bridge Japanese studies. Japan must input to overseas protocols. K. Shimatani/ K-H Symposium/ October 22-23, 2001

  15. ( 2 ) Even if Japan start later, the NDAs can be simultaneous West Japan Phase I Phase II Phase III Simultaneous NDA Phase I Phase II Advanced Bridging Studies (2) This strategy could be applied for the therapeutic areas: • No difference in medical practices • End points already validated (precedent) • Easy to get consistent results K. Shimatani/ K-H Symposium/ October 22-23, 2001

  16. Why Global Studies? 1) ICH recommend to avoid redundancy of clinical studies which have been already done in overseas However, MHLW/ Japanese prescribers need to see Japanese data Global studies Simultaneous NDA Global Studies 2) There are difficult areas to conduct clinical studies in Japan • Small patient population (cancer and others) • Mega-trial (cardiac events, bone fracture) • Difficult to have consistent result (psychiatry and others) K. Shimatani/ K-H Symposium/ October 22-23, 2001

  17. Points to be discussedin Global studies • Speed and Quality • Sample size • Similarity • Dosage • Study design • Medical practice K. Shimatani/ K-H Symposium/ October 22-23, 2001

  18. YES, but……. Collaboration with Asian Countries Speed and QualityHas the Japanese clinical trialenvironment improved? K. Shimatani/ K-H Symposium/ October 22-23, 2001

  19. Collaboration with SMO K. Shimatani/ K-H Symposium/ October 22-23, 2001

  20. Bridging Global study Proveefficacy 1,000 1,000 Prove efficacy Prove efficacy Similarity 400 W J 200 Similarity Sample size/ Similarity • Is it possible to reduce sample size? • Is it necessary to prove efficacy only in Japanese patients? K. Shimatani/ K-H Symposium/ October 22-23, 2001

  21. Similarity K. Shimatani/ K-H Symposium/ October 22-23, 2001

  22. From PK profile West L M H Japan option 1 L M H option 2 l L M option 3 conduct Phase IIa Dosage K. Shimatani/ K-H Symposium/ October 22-23, 2001

  23. Study design/ Medical practice To allow some flexibility in designing of protocol in order to satisfy with local needs - Diagnosis - Primary endpoints - Severity - Secondary endpoints - Demography - Dosage K. Shimatani/ K-H Symposium/ October 22-23, 2001

  24. Summary (1) • Bridging studies minimize the duplication of studies and increase the chances of approval • Differences in extrinsic factors are more important than intrinsic factors in bridging studies K. Shimatani/ K-H Symposium/ October 22-23, 2001

  25. Summary (2) • As an important alternative to bridging studies, we should think to conduct global studies. In particular, we should be aggressive in looking into this for therapeutic areas in which clinical studies are difficult to conduct in Japan alone. In such cases, we should be flexible in choosing sample sizes and protocol designs that will allow both the global objectives as well as the local objectives to be achieved. • We need to explore options that would allow us to collaborate with other countries in Asia when conducting global studies K. Shimatani/ K-H Symposium/ October 22-23, 2001

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