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Randomi sed Clinical Trials: Design, Practice and Reporting  provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.  This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:  Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test  Randomi sed Clinical Trials  is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

This highly popular introduction to confidence intervals has been thoroughly updated and expanded. It includes methods for using confidence intervals, with illustrative worked examples and extensive guidelines and checklists to help the novice.

This book provides statisticians and researchers with the statistical tools – equations, formulae and numerical tables – to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information. Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.

All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.

A concise summary of the statistical methods used in the analysis of survival data with censoring. Emphasizes recently developed nonparametric techniques. Outlines methods in detail and illustrates them with actual data. Discusses the theory behind each method. Includes numerous worked problems and numerical exercises.

Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: «… very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas.» BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

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.

Medical Statistics provides the necessary statistical tools to enable researchers to undertake and understand evidence-based clinical research. It is a practical guide to conducting statistical research and interpreting statistics in the context of how the participants were recruited, how the study was designed, what types of variables were used, what effect size was found, and what the P values mean. It guides researchers through the process of selecting the correct statistics and show how to best report results for presentation and publication. Clear and concise explanations, combined with plenty of examples and tabulated explanations are based on the authors’ popular medical statistics courses. The table of contents is divided into sections according to whether data are continuous or categorical in nature as this distinction is fundamental to selecting the correct statistics. Each chapter provides a clear step-by-step guide to each statistical test with practical instructions on how to generate and interpret the numbers, and present the results as scientific tables or graphs. The chapters conclude with critical appraisal guidelines to help researchers review the reporting of results from each type of statistical test. This new edition includes a new chapter on repeated measures and mixed models and a helpful glossary of terms provides an easy reference that applies to all chapters.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies. The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis. This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.