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
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
Mason JK, McCall, Smith RA. Law and Medical Ethics. London, Butterworths; 1991.
Engelhardt HT, Jr. Bioethics and Secular Humanism: the Search for a Common Morality. London, SCM Press; 1991.
Jonsen AR, Siegler M, Winslade WJ. Clinical Ethics. Third edition. New York, NY: McGraw-Hill; 1992.
Karlawish JH, Lantos J. Community equipoise and the architecture of clinical research. Camb Q Health Ethics. 1997;6(4):385–396.
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.
Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med. 1997;337(14):1003–1005.
Ono S, Kodama Y. Clinical trials and the new good clinical practice guideline in Japan. An economic perspective. Pharmacoecon. 2000;18(2):125–141.
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.
Ijsselmuiden CB, Faden RR. Research and informed consent in Africa—another look. N Engl J Med. 1992;326(12):830–833.
Faria SL, Souhami L. Communication with the cancer patient. Information and truth in Brazil. Ann NY Acad Sei. 1997;809:163–171.
Meyza J. Truth-telling, information, and communication with the cancer patients in Poland. Ann NY Acad Sei. 1997;809:468–479.
Verheggen FW, Nieman FH, Reerink E, Kok GJ. Patient satisfaction with clinical trial participation. Int J Qual Health Care. 1998;10(4):319–330.
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.
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.
Pritchard KI. Is tamoxifen effective in prevention of breast cancer? Lancet. 1998;352(9122):80–81.
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.
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.
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.
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.
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.
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.
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.
Bodenheimer T. Health policy report: uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342:1539–1544.
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.
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.
Hama R. Why Would Drug-Induced Tragedies not End? For the Safety of Drugs. Tokyo, Nihon-Hyo-ronsha; 1996. (in Japanese)
Leflar RB. Informed consent and patients’ rights in Japan. Houston Law Rev. 1996;33(1): 1–112.
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.
Younge D, Moreau P, Ezzat A, Gray A. Communicating with the cancer patients in Saudi Arabia. Ann NY Acad Set. 1997;809:309–316.
Monto AS. The disappearance of Reye’s syndrome—A public health triumph. N Engl J Med. 1999;340(18):1423–1424.
Johnson GM. Reye’s syndrome. NEngl J Med. 1999; 341(11):846.
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)
Japanese Ministry of Health and Welfare. Pharmaceuticals and Medical Devices Safety Information No. 158. January 2000. (in Japanese)
Japanese Ministry of Health and Welfare. Pharmaceuticals and Medical Devices Safety Information No. 163. November 2000. (in Japanese)
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.
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.
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.
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.
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.
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.
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.
Stevenson P. Nepal calls the shots in hepatitis E virus vaccine trial. Lancet. 2000;355(9215):1623.
Shalala D. Protecting research subjects—what must be done. N Engl J Med. 2000;343(11):808–810.
World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284(23):3043–3045.
About this article
Cite this article
Tanida, N. Ethical Considerations in Clinical Trials in Asia. Ther Innov Regul Sci 36, 41–49 (2002). https://doi.org/10.1177/009286150203600108
- Clinical trial