Libri di David Machin

All new medicines and devices undergo early phase trials to assess,interpret and better understand their efficacy, tolerability andsafety. An Introduction to Statistics in Early Phase Trialsdescribes the practical design and analysis of these importantearly phase clinical trials and provides the crucial statisticalbasis for their interpretation. It clearly and concisely providesan overview of the most common types of trials undertaken in earlyphase clinical research and explains the different methodologiesused. The impact of statistical technologies on clinicaldevelopment and the statistical and methodological basis for makingclinical and investment decisions are also explained. * Conveys key ideas in a concise manner understandable bynon-statisticians * Explains how to optimise designs in a constrained or fixedresource setting * Discusses decision making criteria at the end of Phase IItrials * Highlights practical day-to-day issues and reporting of earlyphase trials An Introduction to Statistics in Early Phase Trials is anessential guide for all researchers working in early phase clinicaltrial development, from clinical pharmacologists andpharmacokineticists through to clinical investigators and medicalstatisticians. It is also a valuable reference for teachers andstudents of pharmaceutical medicine learning about the design andanalysis of clinical trials.

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.