David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and UK Children's Cancer Study Group, University of Leicester, UK and Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK Michael J. Campbell, Medical Statistics Group, Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

"…a thorough but concise introduction to study design and data analysis." (E-STREAMS, June 2006) "…a very good attempt to discuss various aspects of clinical research…" (Journal of Biopharmaceutical Statistics, July/August 2006)"This is a well researched, well written, thoughtful, and…easy to read primer…a valuable addition to books for research physicians, medical students, and others…" (Doody's Health Services)"…this book is surprisingly refreshing…could be used in any number of situations with equality utility…" (Canadian Journal of Medical Laboratory Science, 2005)

• Preface ixChapter 1 What is Evidence? 1Chapter 2 Measurement, Forms and Questionnaires 18Chapter 3 Principles of Study Size Calculation 37Chapter 4 Randomisation 59Chapter 5 Cross-sectional and Longitudinal Studies 78Chapter 6 Surveys, Cohort and Case–Control Studies 109Chapter 7 Clinical Trials–General Issues 139Chapter 8 Early Clinical Trials 160Chapter 9 Phase III Trials 188Chapter 10 Diagnosis 209Chapter 11 Prognostic Factor Studies 227References 246Tables 255Index 267

David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and UK Children's Cancer Study Group, University of Leicester, UK and Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK Michael J. Campbell, Medical Statistics Group, Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

"…a thorough but concise introduction to study design and data analysis." (E-STREAMS, June 2006) "…a very good attempt to discuss various aspects of clinical research…" (Journal of Biopharmaceutical Statistics, July/August 2006)"This is a well researched, well written, thoughtful, and…easy to read primer…a valuable addition to books for research physicians, medical students, and others…" (Doody's Health Services)"…this book is surprisingly refreshing…could be used in any number of situations with equality utility…" (Canadian Journal of Medical Laboratory Science, 2005)

• Preface ixChapter 1 What is Evidence? 1Chapter 2 Measurement, Forms and Questionnaires 18Chapter 3 Principles of Study Size Calculation 37Chapter 4 Randomisation 59Chapter 5 Cross-sectional and Longitudinal Studies 78Chapter 6 Surveys, Cohort and Case–Control Studies 109Chapter 7 Clinical Trials–General Issues 139Chapter 8 Early Clinical Trials 160Chapter 9 Phase III Trials 188Chapter 10 Diagnosis 209Chapter 11 Prognostic Factor Studies 227References 246Tables 255Index 267

David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and UK Children's Cancer Study Group, University of Leicester, UK and Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK Michael J. Campbell, Medical Statistics Group, Institute of General Practice and Primary Care, School of Health and Related Sciences, University of Sheffield, UK

"…a thorough but concise introduction to study design and data analysis." (E-STREAMS, June 2006) "…a very good attempt to discuss various aspects of clinical research…" (Journal of Biopharmaceutical Statistics, July/August 2006)"This is a well researched, well written, thoughtful, and…easy to read primer…a valuable addition to books for research physicians, medical students, and others…" (Doody's Health Services)"…this book is surprisingly refreshing…could be used in any number of situations with equality utility…" (Canadian Journal of Medical Laboratory Science, 2005)

• Preface ixChapter 1 What is Evidence? 1Chapter 2 Measurement, Forms and Questionnaires 18Chapter 3 Principles of Study Size Calculation 37Chapter 4 Randomisation 59Chapter 5 Cross-sectional and Longitudinal Studies 78Chapter 6 Surveys, Cohort and Case–Control Studies 109Chapter 7 Clinical Trials–General Issues 139Chapter 8 Early Clinical Trials 160Chapter 9 Phase III Trials 188Chapter 10 Diagnosis 209Chapter 11 Prognostic Factor Studies 227References 246Tables 255Index 267