Consensus and controversy in pharmaceutical statistics

Abstract

Drug development is a highly regulated business. Statistics plays an important part in measuring and reporting the efficacy and tolerability of pharmaceuticals and this is reflected in American, European, Japanese and international guidelines of some considerable detail which cover the way in which clinical trials are to be planned, run and analysed. The dominant framework for analysis is frequentist but Bayesian approaches are becoming more popular. Some controversial issues in drug development are considered in the light of the International Conference on Harmonisation's 1999 international statistical guidelines to see whether any Bayes-frequentist consensus is possible.