All Times EDT
Keywords: Decision Table, Interval Design, MTD, Phase I, Toxicity
The landscape of dose-finding designs for phase I clinical trials is rapidly shifting in the recent years, noticeably marked by the emergence of designs utilizing toxicity probability intervals. While many designs appear to be similar on the surface, the underlying statistical frameworks can be quite different. In addition, it becomes challenging to assess the operating characteristics of these designs via simulations as different designs might be superior in different scenarios, based on different criteria, etc. Recent review papers tend to focus on some aspects of design comparison which may not reveal the global picture of pros and cons of each design. We provide a tutorial and a new criterion that summarize the multi-dimensional operating characteristics into a single value, called the “J-Score”. J-Score takes into account users preference in drug development strategy and safety protection. For example, for some drugs, dose-finding strategy might prefer fast escalation as the safety of the drug has been reliably established. The users can require J-Score to reflect the preference of aggressive dose-finding when assessing various designs. We conduct a comprehensive simulation study to illustrate the performance of main-stream dose-finding designs based on the J-Score. We show the top-designs based on different preferences.