1st Edition

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials

By Andrew P. Grieve Copyright 2022
212 Pages 36 Color Illustrations
by Chapman & Hall

212 Pages 36 Color Illustrations
by Chapman & Hall

212 Pages 36 Color Illustrations
by Chapman & Hall

Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power, assurance and related concepts. This book brings together... Read more

List of Figures..........................................................................................................xi

List of Tables......................................................................................................... xiii

Preface......................................................................................................................xv

Acknowledgements..............................................................................................xix

Author.....................................................................................................................xxi

List of Acronyms................................................................................................ xxiii

1. Introduction......................................................................................................1

2. All Power Is Conditional Unless It’s Absolute..........................................9

3. Assurance........................................................................................................33

4. Average Power in Non-Normal Settings...................................................59

5. Bayesian Power..............................................................................................75

6. Prior Distributions of Power and Sample Size........................................87

7. Interim Predictions......................................................................................101

8. Case Studies in Simulation........................................................................ 113

9. Decision Criteria in Proof-of-Concept Trials..........................................127

10. Surety and Assurance in Estimation........................................................149

References.............................................................................................................161

Appendix 1 Evaluation of a Double Normal Integral...................................171

Appendix 2 Besag’s Candidate Formula.........................................................173

Index......................................................................................................................175

Biography

Andrew P. Grieve is a Statistical Research Fellow in the Centre of Excellence in Statistical Innovation at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia and has been active in most areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved, including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I–IV of clinical development, manufacturing, health economics and clinical operations.

"This is a graduate level/practitioner book in ten chapters covering expected, average and predicted power, assurance and Bayesian power followed by a shift in focus to priors, interim predictions and multiple decision criteria. The final chapter looks at surety. The book is logically laid out, with formulae for the normal theory case, some examples, and helpful figures."
~Maia Lesosky, ISCB Book Reviews