Ethical issues around phase I and phase III clinical trials in cancer

摘要

The results of phase III (randomised) cancer clinical trials underpin evidence-based clinical practice. A standard comparator (control arm) is crucial so that the real value of an intervention can be tested. The goal of phase I trials is to assess the toxicity of a new drug and to determine the maximally tolerable dose to be recommended for subsequent studies to identify efficacy. Guidelines on informed consent intend to inform patients considering enrolment in clinical trials, but surveys of patients participating in cancer trials indicate that patient misunderstanding is common.