6.5 Summary
There are a lot of challenges in designing the first dose-ranging clinical trial.
The two main problems are: (1) there is not much information about the efficacy of
the candidate product available and; (2) too many answers are expected for this trial
to deliver. Project team members tend to anticipate that such a study will establish
the PoC, identify the MinED, characterize the dose-response relationship, and recommend
doses for phase III designs. Fundamental statistical training points out that the
best design is that one study answers only one question. Hence, the nature of a dose-ranging
trial makes it a very difficult design in order to address so many scientific questions,
and so little information to begin with.
In fact, there ...
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