Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지

Clinical Trials for Generation of Bridging Data Do we Need "Koreans only" Additional Phase III Trials for Generation of Bridging Data?

가교자료생성 임상시험 한국인만을 대상으로 한 추가 3상 임상시험이 필요한가?

  • 최성준 (한국와이어스(주) 의학사업부)
  • Received : 2009.07.06
  • Accepted : 2009.07.28
  • Published : 2009.12.30

⟨ Previous Next ⟩

Abstract

The registration of new drug is more difficult every year because health authority requests more data on efficacy and safety, especially in long-term clinical trials. In Korea, health authority usually requests bridging data in Korean subjects in order to evaluate the possibility of extrapolation of foreign data to Korean population. But multinational developmental clinical trials from phase 1 to 3 in Korea are ongoing increasingly and it is the time to evaluate the clinical data in the viewpoint of global drug development. Sometimes phase 3 trial for Koreans only may be the waste of resources and the barrier to delay the access for Korean patients even though the drug is available in other countries some years earlier. In scientific point of view, other methods such as Pharmacokinetics / Pharmacodynamics simulation and modeling may be the one of the options to evaluate the ethnic sensitivity. In this article, I explain the issues in the generation of bridging data using additional Koreans only phase 3 trial and the possible alternative for the future.

Keywords

References

  1. 식품의약품안전청. 가교자료평가가이드라인. 의약품평가가이드 34, 2008
  2. Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997;61(3):275-91 https://doi.org/10.1016/S0009-9236(97)90160-0
  3. 김은미, 김지현. 다인종 다민족 사회의 형성과 사회 조직 - 서울의 외국인 마을 사례. 한국사회학 2008;42(2):1-35, 231-232
  4. Food and Drug Administration. Transcript of FDA Press Conference on Warfarin. August 16, 2007. Available at:http://www.fda.gov/downloads/NewsEvents/What%E2%80%99sNewByTopic/Newsroom/MediaTranscripts/ucm123583.pdf
  5. Food and Drug Administration. FDA approves updated warfarin (Coumadin) prescribing information [press release]. August 16, 2007. Available at: http://www.fda.gov/News/Events/Newsroom/PressAnnouncements/2007/ucm108967.htm
  6. Bristol-Myers Squibb. Plavix labeling information. Available at: http://packageinserts. bms.com/pi/pi_plavix.pdf
  7. Vineis P. The randomized controlled trial in studies using biomarkers. Biomarkers. 2003;8(1):13-32 https://doi.org/10.1080/1354750021000039389
  8. Margolis DJ, Hoffstad O, Strom BL. Association between serious ischemic cardiac outcomes and medications used to treat diabetes. Pharmacoepidemiol Drug Saf. 2008;17(8):753-9. https://doi.org/10.1002/pds.1630
  9. Lalonde RL, Kowalski KG, Hutmacher MM, Ewy W, Nichols DJ, Milligan PA, Corrigan BW, Lockwood PA, Marshall SA, Benincosa LJ, Tensfeldt TG, Parivar K, Amantea M, Glue P, Koide H, Miller R. Model-based drug development. Clin Pharmacol Ther. 2007;82(1):21-32 https://doi.org/10.1038/sj.clpt.6100235
  10. Powell JR, Gobburu JV. Pharmacometrics at FDA: evolution and impact on decisions. Clin Pharmacol Ther. 2007;82(1):97-102 https://doi.org/10.1038/sj.clpt.6100234
  11. Dixon JR Jr. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998;6(2):65-74