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.
David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore and UK Childrena 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
Preface. Chapter 1. What is Evidence. Chapter 2. Measurement, Forms and Questionnaires. Chapter 3. Principles of Study Size Calculation. Chapter 4. Randomisation. Chapter 5. Cross--sectional Longitudinal Studies. Chapter 6. Surveys, Cohort and Case--Control Studies. Chapter 7. Clinical Trails -- General Issues. Chapter 8. Early Clinical Trials. Chapter 9. Phase III Trials. Chapter 10. Diagnosis. Chapter 11. Prognostic Factor Studies. References. Tables. Index.