Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions
INTRODUCTION: THE ROLE OF BIOSTATISTICS IN LATE-STAGE PHARMACEUTICAL DEVELOPMENT The premise of this chapter is that many of today’s standard pharmaceutical development practices in experimental design, trial conduct, and statistical analysis are in need of review and revision if the goals of assuring the development and approval of safe, effective pharmaceuticals are to be maintained. The last four decades have confirmed the value of prospective, controlled, blinded, randomized clinical trials in pharmaceutical development. Refinements of experimental designs and statistical analyses, along with global harmonization of regulatory dossiers, have led to our present status where the basic tenets of phase I to III clinical trials are ubiquitous. The current chapter will not cover a great deal of this old ground. However, a sense of complacency with our status quo could lead us to ignore some serious problems with many of the current practices.