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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

From the Department of Paediatric Oncology, Royal Hospital for Sick Children, Bristol, and Sir James Spence Institute of Child Health, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom; St Jude Children’s Research Hospital, Memphis, TN; and Montreal Children’s Hospital, McGill University Health Centre, Montreal, Quebec, Canada.

Address reprint requests to E.J. Estlin, MD, PhD, Department of Paediatric Oncology, Royal Hospital for Sick Children, St Michael’s Hill, Bristol BS2 8BJ, United Kingdom; email e.j.estlin{at}bristol.ac.uk

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 hematologists 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 POG-affiliated pediatricians responded. Thirty-two UKCCSG and 51 POG 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 POG 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 for toxicity and benefit for those children who participate in these studies.

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