Ethics and the Problems of Clinical Trials in Children

  • George M. Maxwell


It is the responsibility of the doctor to give effective and appropriate treatment to his patients, and to do so in keeping with the characteristics and wishes of the individual. This responsibility is based upon skill and knowledge on the part of the doctor, and on trust and acceptance on the part of the patient that his doctor is benevolently motivated. Any therapeutic intervention involving the use of potent agents is an experiment in modifying, or intervening in a disease process. The prescription is given in the expectation of reproducing in the individual patient a result which has been thought to be helpful in many other patients. The controls in this experiment are the skills, knowledge and experience of the doctor, and his estimate of the difference between the patient under active consideration, and those other patients whom he has treated, or whose treatment he has studied. The result for the patient is recovery or otherwise, sometimes influenced by a drug. Intervention may also be to the end of preventing disease, at its simplest by advising the patient to avoid a harmful non-medical practice, such as smoking, or modifying a life-style such as over-eating; in such instances an adverse long-term effect is reasonably anticipated on the basis of adequately proven studies, and a specific amelioration of the health of the individual as well as the group, can reasonably be anticipated by the proposed action.


Duodenal Atresia Proven Study Rigorous Statistical Analysis Active Consideration Specific Amelioration 


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  1. American Academy of Pediatrics–Committee on Ethics (1977) ‘Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations’, Pediatrics, 60, 91–101Google Scholar
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  7. Schafer, A. (1982) ‘The Ethics of the Randomised Clinical Trial’, New Engl. J. Med., 307, 719–724CrossRefGoogle Scholar

Copyright information

© George M. Maxwell 1984

Authors and Affiliations

  • George M. Maxwell
    • 1
  1. 1.University of AdelaideAustralia

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