Ethics in the Design and Conduct of Clinical Trials

• Jeremy Sugarman ^[1]
  1. [1] Duke University

     Duke University

     Township of Durham, Estados Unidos

     
• Localización: Epidemiologic reviews, ISSN 0193-936X, ISSN-e 1478-6729, Vol 24, 1, 2002, págs. 54-58
• Idioma: inglés
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• Resumen

  • The history of medicine reveals the need for clinical research. All too frequently, interventions thought to be safe and effective by clinicians prove to be otherwise. The current emphasis on “evidence-based medicine” enunciates the need for carefully obtained data from carefully conducted clinical research; yet the history of medical research in general, and clinical research in particular, has been an unfortunate and littered one in which some physician-scientists have undermined the rights and interests of the participants.

    While some of the most frequently cited examples of unethical research are clearly egregious, such as the dangerous experimentation on unwilling concentration camp prisoners by Nazi physicians, others are more subtle and involve the misuse of commonly employed, rigorous methods of study design such as randomization and use of placebos. While underrecognition of these issues may be the norm, recent headlines demonstrate that ethical issues associated with certain types of study designs can animate substantial debate. Witness, for example, the controversy over the use of placebo controls in trials aimed at decreasing vertical transmission of human immunodeficiency virus infection (1). Regardless of whether such ethical issues are overt or subtle, it is critical that persons designing, sponsoring, overseeing, conducting, reviewing, and reading the results of clinical research understand these issues so as to ensure that all persons who agree to participate in research are adequately protected.