An authoritative resource that offers the statistical tools and software needed to design and plan valid clinical studies

Now in its fourth and extended edition,Sample Sizes for Clinical, Laboratory and Epidemiology Studiesincludes the sample size software (SSS) and formulae and numerical tables needed to design valid clinical studies. The text covers clinical as well as laboratory and epidemiology studies and contains the information needed to ensure a study will form a valid contribution to medical research.

The authors, noted experts in the field, explain step by step and explore the wide range of considerations necessary to assist investigational teams when deriving an appropriate sample size for their when planned study. The book contains sets of sample size tables with companion explanations and clear worked out examples based on real data. In addition, the text offers bibliography and references sections that are designed to be helpful with guidance on the principles discussed.

This revised fourth edition:

Written for medical researchers from all specialities and medical statisticians,Sample Sizes for Clinical, Laboratory and EpidemiologyStudies offers an updated fourth edition of the important guide for designing and planning reliable and evidence based clinical studies.

David Machin, Leicester Cancer Research Centre, University of Leicester, Leicester and Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.

Michael J. Campbell, Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.

Say Beng Tan, SingHealth Duke-NUS Academic Medical Centre, Singapore.

Sze Huey Tan, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore.

Preface vii

1 Basic Design Considerations 1

2 Further Design Considerations 29

3 Binary Outcomes 41

4 Ordered Categorical Outcomes 55

5 Continuous Outcomes 67

6 Rate Outcomes 83

7 Survival Time Outcomes 99

8 Paired Binary, Ordered Categorical and Continuous Outcomes 117

9 Confidence Intervals 137

10 Repeated Outcome Measures 157

11 NonInferiority and Equivalence 169

12 Cluster Designs 195

13 Stepped Wedge Designs 215

14 More than Two Groups Designs 229

15 Genomic Targets and DoseFinding 239

16 Feasibility and Pilot Studies 251

17 Therapeutic Exploratory Trials: Single Arm with Binary Outcomes 269

18 Therapeutic Exploratory Trials: Survival, Dual Endpoints, Randomised and Genomic Targets 283

19 The Correlation Coefficient 305

20 Observer Agreement Studies 317

21 Reference Intervals and Receiver Operating Curves 339

22 Sample Size SoftwareSSS 361

Cumulative References 363

Index 381