When cure is not the goal: Ethical issues surrounding early-phase research

Pediatric cancer was once a uniformly fatal disease. Sidney Farber, a pioneer of pediatric chemotherapy, was initially criticized for tormenting children by administering experimental chemotherapy when it would have been kinder and gentler to “let them die in peace.” [1] Now, almost 70 years later, the 5-year survival rates in pediatric leukemia are greater than 80% [2]. Clinical studies have served as the engine for these successes. Today, approximately 80% of children with cancer are enrolled in clinical trials. However, the benefits of these studies to society must be balanced against the risks to individual participants, and research subjects must be protected from coercion, exploitation, and any undue harm.