Quality of Life & Palliative Care Featured Research

Informed Consent in Pediatric Phase I Cancer Trials



The primary goal of this research project is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials. The project will take place at six of the most active Phase I pediatric programs in North America, with coordination, data entry and analysis at the Cleveland Clinic Foundation’s Department of Bioethics. The long-term objective will be to improve care for children with refractory cancer and their families by developing a fuller understanding of the Phase I consent communication process, comprehension of parents and older children, and perspectives of clinician-investigators. The research plan is based on the premise that a rigorous scientific methodology, which this team has previously applied in the Phase III newly diagnosed cancer context, can be adapted to provide accurate and comprehensive information about informed consent in Phase I trials. 


Specific Aims