title: Ethical issues in including pediatric cancer patients in drug development trials.
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.
authors.affiliation: Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Katarina
authors.initials: K
authors.lastname: Aleksa
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D026686:Beneficence; D002648:Child; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods; D026690:Ethics, Clinical; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D026712:Value of Life
chemical_list: D000970:Antineoplastic Agents