Consensus and controversy in pharmaceutical statistics

Stephen Senn*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

62 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)135-176
Number of pages42
JournalJournal of the Royal Statistical Society Series D: The Statistician
Issue number2
Publication statusPublished - 2000
Externally publishedYes


  • Bayesian inference
  • Bioequivalence
  • Cross-over trials
  • Frequentist inference
  • Model checking
  • Multiplicity
  • Randomization
  • Sequential trials


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