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Ethical Issues in Including Pediatric Cancer Patients in Drug Development Trials

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Abstract

Since the biology, pharmacology and toxicology of pediatric cancer is so different from cancer in adults, it is impossible to extrapolate from adult cancer experience; however, conducting studies in children with cancer is ethically and clinically very complex. This is especially so in phase 1 trials, aimed at dose finding for new modalities, where the chances to cure the child who failed standard therapy are marginal to non-existent. Hence, the child may be exposed to risks and discomfort which may be unbalanced by potential benefits. This situation, which is difficult for consenting adults, is much more complex when a parent gives proxy consent. This review addresses the ethical and clinical framework of such studies in the most vulnerable of children.

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Acknowledgements

Katarina Aleksa was supported by a studentship from the Canadian Institute of Health Research (CIHR). Gideon Koren is a Senior Scientist of the CIHR. This study was supported by a CIHR operating grant.

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Authors and Affiliations

  1. Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada

    Katarina Aleksa &  Gideon Koren

  2. Department of Pharmacology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Katarina Aleksa

  3. Department of Pediatrics, Pharmacology, Pharmacy, Medicine and Medical Genetics, and Pharmaceutical Science, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Gideon Koren

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  1. Katarina Aleksa
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  2. Gideon Koren
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Correspondence to Gideon Koren.

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Aleksa, K., Koren, G. Ethical Issues in Including Pediatric Cancer Patients in Drug Development Trials. Pediatr-Drugs 4, 257–265 (2002). https://doi.org/10.2165/00128072-200204040-00005

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