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Phase I trials in pediatric oncology: Perceptions of pediatricians from the United Kingdom Children's Cancer Study Group and the Pediatric Oncology Group

Lookup NU author(s): Simon Cotterill, Professor Andrew Pearson


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Purpose: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit and the ethical concerns of pediatric hematalogists and oncologists in the United Kingdom and North America. Methods: A survey instrument consisting of 19 open- and closed-ended questions was sent to United Kingdom Children's Cancer Study Group (UKCCSG)- and Pediatric Oncology Group (POG)-affiliated pediatricians. Results: fifty-three UKCCSG- and 78 FOG-affiliated pediatricians responded. Thirty-two UKCCSG and 51 FOG respondents had previously entered at least one child into a phase I study. Overall, respondents believed that parents entered their children for medical benefit altruism, and hope of cure. Although many respondents believed that children could benefit from medical improvement, feelings of altruism, and maintenance of hope, the chance of cure or complete remission was thought to be small. Similarly, parents were thought to potentially benefit through altruism and maintenance of hope, Whereas 83% of UKCCSG respondents indicated that phase I trials were associated with ethical difficulties, this was a concern for 48% of FOG respondents. The main ethical concerns of respondents were risk of toxicity, consent of the child, unrealistic hope, and coercion. Conclusion: The respondents in this survey expressed mainly ethical concerns regarding the conduct of phase I trials and had realistic expectations of the potential far toxicity and benefit for those children who participate in these studies. (C) 2000 by American Society of Clinical Oncology.

Publication metadata

Author(s): Pearson ADJ; Cotterill S; Estlin EJ; Pratt CB; Bernstein M

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Oncology

Year: 2000

Volume: 18

Issue: 9

Pages: 1900-1905

ISSN (print): 0732-183X

ISSN (electronic): 1527-7755

Publisher: American Society of Clinical Oncology