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Abstract:
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The specific aims of Phase I clinical trials in oncology have undergone substantial changes over the last several years. They used to have a single simple objective and this was to show that the investigational agent is adequately well tolerated in a heterogeneous patient population, in general, across a broad range of solid tumors. This straightforward objective has evolved into a rather more ambitious set of objectives among which is to identify the most effective dose, the right schedule, and the right patient population in terms of likelihood of antitumor activity. The patient population can include all comers or molecularly defined subgroups which can complicate the hypotheses regarding the investigational agent’s mechanism of action even further; to screen a potentially active agent from a number of potentially active agents and to stop as early as possible drugs that, in the light of the information observed so far, are unlikely to be successful (futile); and to investigate new combinations of drugs which have a history of use individually or in other combinations. In this talk, I will discuss the Ethical and Policy Implications of Seamless Phase 1 Oncology Trials.
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