An Introduction to Statistics in Early Phase Trials (eBook)

Steven A. Julious, Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK. Say-Beng Tan, Singapore Clinical Research Institute and Duke-NUS Graduate Medical School, Singapore. David Machin, Children's Cancer and Leukaemia Group (CCLG), University of Leicester, UK.

Chapter 1 Early phase trials 1

Chapter 2 Introduction to pharmacokinetics 13

Chapter 3 Sample size calculations for clinical trials 37

Chapter 4 Crossover trial basics 55

Chapter 5 Multi-period crossover trials 71

Chapter 6 First time into man 87

Chapter 7 Bayesian and frequentist methods 113

Chapter 8 First-time-into-new-population studies 125

Chapter 9 Bioequivalence studies 139

Chapter 10 Other Phase I trials 169

Chapter 11 Phase II trials: general issues 187

Chapter 12 Dose-response studies 197

Chapter 13 Phase II trials with toxic therapies 211

Chapter 14 Interpreting and applying early phase trial results 223

Chapter 15 Go/No-Go criteria 231

Appendix 245

References 251

Index 257

"An Introduction to Statistics in Early Phase Trials" is an
admirably concise and practical guide to the pertinent context,
principles and formulae for statisticians inexpert in
the application of their discipline to Phase I and II clinical
research". (Journal of Clinical Research Best Practices, 1 March
2011)



"An Introduction to Statistics in Early Phase
Trials provides concise descriptions of many early phase trial
designs, along with the statistical equations necessary to gather
and analyze the data" (Annals of Pharmacotherapy,
2010)

"I enjoyed reading the work of Dr. Julious, Tan, and
Machin,found it quite useful, and recommend it to others teaching
about, working with, or considering work in the learning phase of
drug development." (Journal of Biopharmaceutical Statistics,
2011)