Ethical issues in including pediatric cancer patients in drug development trials

K. Aleksa, G. Koren

Research output: Contribution to journalReview articlepeer-review

8 Scopus citations


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.

Original languageEnglish
Pages (from-to)257-265
Number of pages9
JournalPaediatric Drugs
Issue number4
StatePublished - 2002
Externally publishedYes


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