Seeing through the mist – consequences of decisions in phase II

Interview with Trevor Smart

What’s interesting about the early phase?
What are the typical decisions for phase II?
Speaking about a new indication, how are decisions being taken across the industry?
How should we think about phase II studies in this setting?
What statistical approaches do we have to formulate this thinking?

In this episode, Trevor and I discuss a case study to go through the step by step procedure of phase II. We also talk about the following points:

  • What are decision rules?
  • How can we use prior elicitation?
  • What and how do you come to a prior distribution and what is a design prior?
  • What role do relevant and non-relevant differences play here?
  • Any recommended reading?
  • What you can do differently to make sure, we make better decisions in phase II?

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