Choosing right metrics to enable sound decisions
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*Christy Chuang-Stein, Pfizer  Jonathan French, Pfizer, Inc.  Simon Kirby, Pfizer, Inc.  Scott Marshall, Pfizer, Inc. 


There are many decision points along the product development continuum. Sound decisions begin with asking the right questions and choosing the right metrics to help determine the decision criteria. In this talk, we will look at metrics that address the unique needs and the strength of knowledge required to make decisions at various stage gates. The latter include proof of concept, dose-ranging decision and confirmation of pre-specified hypotheses. We will illustrate how decision criteria could be set up using these metrics. The criteria have important implications to the design of the trials that are to be the evidentiary basis for the decisions. The interplay between the criteria and design features will jointly determine the operating characteristics of the designs and ultimately the quality of our decisions.