Reconceptualizing the ethics of phase 1 pediatric clinical trials in oncology.

摘要

Phase 1 clinical trials continue to present bioethical challenges in pediatric practice, and pediatric oncology has developed as a subspecialty in part due to a particularly robust research culture. In this project, I explore continuing ethical challenges and call the commonly accepted notion of research as standard practice into question. I suggest that therapeutic misconceptions obscure deeper ethical questions about just how much sacrifice current children can reasonably be asked to endure for future generations and how much and what should be done in the name of maintaining hope near the end of life. It is my contention that phase 1 trials are not the best way to cope with impending death and often require parents and children to give up meaningful experiences for medical heroics.;To examine my hypothesis, I first consider the history of pediatric research ethics with a special focus on the Ramsey-McCormick debate and current federal regulations. Finding little help here, I then turn to the relationships among parents, children, and physicians to discover whether phase 1 trials in their current form can be justified based on the obligations professionals and families have to one another. I conclude that phase 1 trials do not constitute a reasonable way to meet interpersonal moral obligations and represent an impoverished view of medical care at the end of life.;Having argued against phase 1 trials in their current form, I then consider a possible alternative, arguing for hospice care as standard care and for a clinical innovation paradigm. A clinical innovation paradigm permits physicians to try novel interventions when standard therapies fail according to individual patient needs. At the same time, clinical innovation requires the prioritization of hospice and palliative care for seriously ill children. Although any change will be difficult and requires further analysis, I contend that a clinical innovation paradigm constitutes a better ethical alternative compared to more traditional protocol-driven early phase trials.