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

Purpose: To identify areas of concern regarding the conduct of phase I tria ls, the perceived expectations and motivations of the parents of children e ntered, the expectations of toxicity and benefit and the ethical concerns o f pediatric hematalogists and oncologists in the United Kingdom and North A merica. Methods: A survey instrument consisting of 19 open- and closed-ended questi ons 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 o ne child into a phase I study. Overall, respondents believed that parents e ntered their children for medical benefit altruism, and hope of cure. Altho ugh many respondents believed that children could benefit from medical impr ovement, feelings of altruism, and maintenance of hope, the chance of cure or complete remission was thought to be small. Similarly, parents were thou ght to potentially benefit through altruism and maintenance of hope, Wherea s 83% of UKCCSG respondents indicated that phase I trials were associated w ith ethical difficulties, this was a concern for 48% of FOG respondents. Th e main ethical concerns of respondents were risk of toxicity, consent of th e child, unrealistic hope, and coercion. Conclusion: The respondents in this survey expressed mainly ethical concern s 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.