ABSTRACT
This chapter discusses the philosophy of problem solving and mathematics and statistics as important tools for problem solving. It provides a brief discussion of the modern drug development process and revisits some issues in the application of statistics in evidence-based science. Considering that drug development is far away from pure science, achieving acceptance is, in many cases, one of the most complicated parts of the solution. Drug development is a very expensive process which requires massive investment of capital into both human resources and materials. Health authorities have been constantly raising the bar for data quality and scientific rigor of drug development programs. Within a company, drug development teams are formed to work on particular projects within a particular therapeutic area. Clinical research is carried out through randomized controlled trials, which have been recognized as the gold standard for clinical investigation.
