This paper is intended as a commentary on some statistical and scientific issues arising from current practices in new drug development. We wish to provoke thought concerning the question, “How can we better utilize the results of early development studies to obtain better understanding of the potential usefulness of a new drug before committing to a narrowly-focused, resource-intensive, Phase III program?” The role of hypothesis generation and exploratory data analysis is discussed in the context of the “research continuum” of drug development.
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