The current role of statistics in the drug development program is dominated by the “planning and analyzing a single trial” paradigm. On the one hand, there is some need to structure such a program. On the other hand, a great deal of flexibility is required to allow researchers to incorporate lessons learned from experience into the inferential procedures. Some statistical methods for planning and analyzing more than one trial are sketched. The limitation of frequentist type inference to cover the decisions following a complex development process are addressed. For integrative statistical coverage of the decicion procedures in a drug development program, extensive modelling based upon various assumptions will be required. This will lead to the main challenge, to make it real without losing credibility, transparency, and persuasiveness.
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