Clinical Trials

❘❙❚■ ContentsIntroductionThe inspiration…Over 7 years ago, while working on design and analyses of projects conductedat the Clinical Trials and Evaluation Unit at the Royal Brompton Hospital,London, a young clinician and statistician began what was to become a longjourney together into clinical trials. We were fortunate to meet Andrew Ward,Publisher from Remedica, along the way, and our journey culminated in thecreation of this book – initially starting with short 500-word articles explainingconcepts such as P-values and confidence intervals, and concluding in 5,000 wordarticles explaining multicenter studies and meta-analyses.Along the way, we have published more than 30 peer-reviewed and invited paperswith others, continually building our writing style to be able to appeal to clinicians,statisticians, and trial workers alike. This book is therefore unique in that itquickly demystifies and brings the language of clinical trials within reach of all.The audience…This book describes and explains the issues that occur during all stages of clinicaltrials, covering design, analysis, and reporting of clinical trials, with an emphasison open, practical, and effective communication. The material is therefore idealfor those involved in designing, conducting, analyzing, evaluating, interpreting,or publishing clinical trials – including physicians, medical students, clinicaland medical researchers, study co-ordinators, project managers, medical writers,data managers, pharmaceutical scientists, statisticians, medical economists,medical analysts, and those working in the health services who have to evaluatesuch material.The material…Our book consists of 38 chapters in five sections: fundamentals of trial design,alternative trial designs, basics of statistical analysis, special trial issues in dataanalysis, and reporting of trials. The chapters can be read consecutively orindividually, with Chapter 1 providing an overview and some reading guidelines.To hold interest, the chapters are scattered with numerous practical examplesof concepts and illustrations relating to trials, and there are even chaptersenabling one to become a polished trial sceptic. The chapters on tables and figuresare essential for those submitting their reports for regulatory approval or forpublication, and the statistical chapters provide step-by-step guidance on whichtests to use.xii