Ethical Considerations in Clinical Trials in Asia
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Drug Information Journal, Vol. 36, pp. 41-49, 2002 Printed in the USA. All rights reserved.
ETHICAL CONSIDERATIONS IN CLINICAL TRIALS IN ASIA NORITOSHI TANIDA, MD, PHD, DTM&H Associate Professor, Department of Internal Medicine 4, Hyogo, Japan
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
convenient way to analyze the issues (3). This article briefly discusses Jonsen’s fourelements of ethical analysis: medical indications (beneficence or nonmaleficence), patient preferences (autonomy), quality of life, and contextual features, in relation to clinical trials. Examples are presented. Ethics in clinical trials specific to Asia are discussed.
INTRODUCTION UNCERTAINTY IS THE primary reason to conduct clinical trials. Uncertainty means that certain issues surrounding clinical trials are unresolved, and must be analyzed scientifically, morally, and ethically. Medical morals dictate the actions and beliefs that regulate the day-to-day judgments of doctors, and medical ethics analyzes the universal principles on which decisions are made (1). Engelhardt suggests that ethical or bioethical evaluation is required whenever unfamiliar moral issues are encountered (2). Thus, ethical analysis is important in clinical trials that are now conducted internationally in countries with different values and morals. In dealing with such ethical issues, Jonsen’s four-element structure analysis is a
ANALYSIS OF CLINICAL ETHICS Medical Indications (Beneficence or Nonmaleficence) Medical interventions form the gateway for further diagnostic, therapeutic, and preventive activities. Issues at this stage may include medical goals, efficacy, risk, necessity, and overall goals. The patient needs to be cured or cared for. In preventive trials, the intervention must prevent healthy persons from becoming ill. Clinical trials are proposed because the need for medical intervention is obvious. Medical indications are primarily technical, hence this element is not a serious concern in clinical trials. However, medical indi-
Presented at the DIA Meeting “Evolution of Drug Regulatory Process in Asia,” September 28-29, 2000, Seoul, Korea. Reprint address: Noritoshi Tanida, MD, PhD, DTM&H, Hyogo College of Medicine, 1-1 Mukogawacho, Nishinomiya, Hyogo 663-8501, Japan. E-mail: yonnai @hyo-med.ac.jp.
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