The Design of Studies for Medical Research

The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development.  With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design.  This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

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