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The Complexity of Consenting to Clinical Research in Phase I Pediatric Cancer Studies

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Abstract

The principal aim of phase I studies is to define the recommended dosing of drugs for phase II studies through assessment of drug pharmacokinetics and observation of the drug’s toxicity profile. In the setting of pediatric oncology, the use of an experimental drug in phase I study is offered when prognosis is poor. Thus, phase I oncology studies are not given to patients with a primary purpose of an intent to cure. They may offer little to no treatment benefit and carry a potential toxic effect. They may offer other benefits such as improved quality of life and relief of pain, however. Three parties are involved in the informed consent process: the parents, patients, and physicians. Families report hope as the main cause for enrollment. Physicians focus on providing information so families can decide about participation. Physicians also try to maintain hope despite understanding the nature of the disease. This makes the informed consent complicated for all parties involved in the process. The purpose of this review is to discuss the aims of phase I studies in pediatric oncology and to convey the ethical challenges that patients, parents, and physicians are facing when discussing informed consent with potential study participants.

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Acknowledgments

T. Schechter and R. Grant report no relevant conflicts of interest. No sources of funding were used to support the writing of this manuscript.

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Authors and Affiliations

  1. Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada

    Tal Schechter & Ronald Grant

  2. University of Toronto, Toronto, ON, Canada

    Tal Schechter & Ronald Grant

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  1. Tal Schechter
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  2. Ronald Grant
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Correspondence to Tal Schechter.

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This article is part of the topical collection on Ethics of Pediatric Drug Research.

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Schechter, T., Grant, R. The Complexity of Consenting to Clinical Research in Phase I Pediatric Cancer Studies. Pediatr Drugs 17, 77–81 (2015). https://doi.org/10.1007/s40272-014-0113-1

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