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Ethical Considerations in Clinical Trials in Asia

  • Noritoshi TanidaEmail author
Article

Abstract

Clinical trials, by their very nature, are a kind of second choice involving uncertainty from the beginning. The inherent characteristics of clinical trials necessitate ethical considerations. Ethical analysis emphasizes the importance of medical indications, patient preferences, trial quality, and contextual features. Instances of clinical trial misconduct are usually due to insufficient analysis of medical indications, which ignore patient preferences and the way in which investigators assess clinical trial results. These problems are universal concerns. In the context of clinical trials, these are subjective needs in every society. For clinical trials conducted in Asia, ethics must consider the specific needs and benefits of Asian people

Key Words

Ethics Clinical trial Asia Placebo Culture 

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References

  1. 1.
    Mason JK, McCall, Smith RA. Law and Medical Ethics. London, Butterworths; 1991.Google Scholar
  2. 2.
    Engelhardt HT, Jr. Bioethics and Secular Humanism: the Search for a Common Morality. London, SCM Press; 1991.Google Scholar
  3. 3.
    Jonsen AR, Siegler M, Winslade WJ. Clinical Ethics. Third edition. New York, NY: McGraw-Hill; 1992.Google Scholar
  4. 4.
    Karlawish JH, Lantos J. Community equipoise and the architecture of clinical research. Camb Q Health Ethics. 1997;6(4):385–396.CrossRefGoogle Scholar
  5. 5.
    Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration’s final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med. 1998;5(4):359–368.PubMedCrossRefPubMedCentralGoogle Scholar
  6. 6.
    Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med. 1997;337(14):1003–1005.PubMedCrossRefPubMedCentralGoogle Scholar
  7. 7.
    Ono S, Kodama Y. Clinical trials and the new good clinical practice guideline in Japan. An economic perspective. Pharmacoecon. 2000;18(2):125–141.CrossRefGoogle Scholar
  8. 8.
    Lynoe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. Br Med J. 1991;303(6803):610–613.CrossRefGoogle Scholar
  9. 9.
    Ijsselmuiden CB, Faden RR. Research and informed consent in Africa—another look. N Engl J Med. 1992;326(12):830–833.PubMedCrossRefPubMedCentralGoogle Scholar
  10. 10.
    Faria SL, Souhami L. Communication with the cancer patient. Information and truth in Brazil. Ann NY Acad Sei. 1997;809:163–171.CrossRefGoogle Scholar
  11. 11.
    Meyza J. Truth-telling, information, and communication with the cancer patients in Poland. Ann NY Acad Sei. 1997;809:468–479.CrossRefGoogle Scholar
  12. 12.
    Verheggen FW, Nieman FH, Reerink E, Kok GJ. Patient satisfaction with clinical trial participation. Int J Qual Health Care. 1998;10(4):319–330.PubMedCrossRefPubMedCentralGoogle Scholar
  13. 13.
    Llewellyn-Thomas HA, McGreal MJ, Thiel EC, Fine S, Erlichman C. Patients’ willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation. Soc Sei Med. 1991;32(1):35–42.CrossRefGoogle Scholar
  14. 14.
    Wong CS, Jelacic S, Habeeb RL, Watkins SL, Tan PI. The risk of the hemolytic-uremic syndrome after antibiotic treatment of Escherichia coli 0157:H7 infections. N Engl J Med. 2000;342(26): 1930–1936.PubMedPubMedCentralCrossRefGoogle Scholar
  15. 15.
    Pritchard KI. Is tamoxifen effective in prevention of breast cancer? Lancet. 1998;352(9122):80–81.PubMedCrossRefPubMedCentralGoogle Scholar
  16. 16.
    Psaty BM, Weiss NS, Furberg CD, Koepsell TD, Siscovick DS, Rosendaal FR, et al. Surrogate end-points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease. JAMA. 1999;282(8):786–790.PubMedCrossRefPubMedCentralGoogle Scholar
  17. 17.
    LeLorier J, Grégoire G, Benhaddad A, Lapierre J, Derderian F. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med. 1997;337(8):536–542.PubMedCrossRefPubMedCentralGoogle Scholar
  18. 18.
    Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet. 2000;355(9209):1064–1069.PubMedCrossRefPubMedCentralGoogle Scholar
  19. 19.
    Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997;337(12):853–856.PubMedCrossRefPubMedCentralGoogle Scholar
  20. 20.
    Desvarieux M. Questions about a placebo-controlled trial of preventive therapy for tuberculosis in HIV-infected Ugandans. N Engl J Med. 1998;338(12): 841.PubMedCrossRefPubMedCentralGoogle Scholar
  21. 21.
    Perinatal HIV Intervention Research in Developing Countries Workshop Participants. Science, ethics, and the future of research into maternal infant transmission of HIV-1. Lancet. 1999;353(9155):832–835.CrossRefGoogle Scholar
  22. 22.
    Task Force on Principles for Economic Analysis of Health Care Technology. Economic analysis of health care technology. A report on principles. Ann IntMed. 1995;123(1):61–70.CrossRefGoogle Scholar
  23. 23.
    Bodenheimer T. Health policy report: uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342:1539–1544.PubMedCrossRefPubMedCentralGoogle Scholar
  24. 24.
    Moynihan R, Bero L, Ross-Degnan D, Henry D, Lee K, Watkins J, et al. Coverage by the news media of the benefits and risks of medications. N Engl J Med. 2000,342(22): 1645–1650.PubMedCrossRefPubMedCentralGoogle Scholar
  25. 25.
    Shretta R, Brugha R, Robb A, Snow RW. Sustain-ability, affordability, and equity of corporate drug donations: the case of Malarone. Lancet. 2000; 355(9216):1718–1720.PubMedCrossRefPubMedCentralGoogle Scholar
  26. 26.
    Hama R. Why Would Drug-Induced Tragedies not End? For the Safety of Drugs. Tokyo, Nihon-Hyo-ronsha; 1996. (in Japanese)Google Scholar
  27. 27.
    Leflar RB. Informed consent and patients’ rights in Japan. Houston Law Rev. 1996;33(1): 1–112.Google Scholar
  28. 28.
    Tanida N, Yamamoto N, Sashio H, Nakamura Y, Sakagami T, Sawada Y, et al. Influence of truth disclosure on quality of life in cancer patients. Int J Clin Oncol. 1998;3(6):386–394.CrossRefGoogle Scholar
  29. 29.
    Younge D, Moreau P, Ezzat A, Gray A. Communicating with the cancer patients in Saudi Arabia. Ann NY Acad Set. 1997;809:309–316.CrossRefGoogle Scholar
  30. 30.
    Monto AS. The disappearance of Reye’s syndrome—A public health triumph. N Engl J Med. 1999;340(18):1423–1424.PubMedCrossRefPubMedCentralGoogle Scholar
  31. 31.
    Johnson GM. Reye’s syndrome. NEngl J Med. 1999; 341(11):846.Google Scholar
  32. 32.
    Japanese Ministry of Health and Welfare Study Group. The Relationship Between Drugs and Etiology-Unknown Acute Encephalopathy with Serious Sequela. Tokyo, The Ministry of Health and Welfare; 1994. (in Japanese)Google Scholar
  33. 33.
    Japanese Ministry of Health and Welfare. Pharmaceuticals and Medical Devices Safety Information No. 158. January 2000. (in Japanese)Google Scholar
  34. 34.
    Japanese Ministry of Health and Welfare. Pharmaceuticals and Medical Devices Safety Information No. 163. November 2000. (in Japanese)Google Scholar
  35. 35.
    Blanche S. Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World. N Engl J Med. 1998; 338(12):837–838.PubMedPubMedCentralGoogle Scholar
  36. 36.
    Barzilai A, Sperling RS, Hyatt AC, Wedgwood JF, Reidenberg BE, Hodes DS. Mother to child transmission of human immunodeficiency virus 1 infection despite zidovudine therapy from 18 weeks of gestation. Pediatr Infect Dis J. 1990;9(12):931–933.PubMedCrossRefPubMedCentralGoogle Scholar
  37. 37.
    Watts DH, Brown ZA, Tartaglione T, Burchett SK, Opheim K, Coombs R, et al. Pharmacokinetic disposition of zidovudine during pregnancy. J Infect Dis. 1991;163(2):226–232.PubMedCrossRefPubMedCentralGoogle Scholar
  38. 38.
    O’Sullivan MJ, Boyer PJ, Scott GB, Parks WP, Weiler S, Blum MR, et al. The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: phase I acquired immunodeficiency syndrome clinical trials group study (protocol 082). Zidovudine Collaborative Working Group. Am J Obstet Gynecol. 1993;168(5):1510–1516.PubMedCrossRefPubMedCentralGoogle Scholar
  39. 39.
    Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O’Sullivan MJ, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331(18):1173–1180.PubMedCrossRefPubMedCentralGoogle Scholar
  40. 40.
    Shaffer N, Chuachoowong R, Mock PA, Bhadrakom C, Siriwasin W, Young NL, et al. Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group. Lancet. 1999;353(9155):773–780.PubMedCrossRefPubMedCentralGoogle Scholar
  41. 41.
    Burri C, Nkunku S, Merolle A, Smith T, Blum J, Brun R. Efficacy of new, concise schedule for melar-soprol in treatment of sleeping sickness caused by Trypanosoma brucei gambiense: a randomised trial. Lancet. 2000;355(9213):1419–1425.PubMedCrossRefPubMedCentralGoogle Scholar
  42. 42.
    Stevenson P. Nepal calls the shots in hepatitis E virus vaccine trial. Lancet. 2000;355(9215):1623.PubMedCrossRefPubMedCentralGoogle Scholar
  43. 43.
    Shalala D. Protecting research subjects—what must be done. N Engl J Med. 2000;343(11):808–810.PubMedCrossRefPubMedCentralGoogle Scholar
  44. 44.
    World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284(23):3043–3045.CrossRefGoogle Scholar

Copyright information

© Drug Information Association, Inc 2002

Authors and Affiliations

  1. 1.Department of Internal Medicine 4Hyogo College of MedicineNishinomiya, HyogoJapan

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