Ein fundiertes Referenzwerk zu den statistischen Instrumenten und Softwareprogrammen, die fur das Design und die Planung klinischer Studien erforderlich sind. Die erweiterte 4. Auflage von Sample Sizes for Clinical, Laboratory and Epidemiology Studies beinhaltet eine Sample-Size-Software (SSS), Formeln und nummerische Tabellen fur die Gestaltung valider klinischer Studien. Das Fachbuch behandelt ebenfalls Labor- und epidemiologische Studien und stellt die Informationen zur Verfugung, damit Studien einen wesentlichen Beitrag zur medizinischen Forschung leisten. Die Autoren, allesamt anerkannte Experten des Fachgebiets, erlautern und untersuchen Schritt fur Schritt die vielfaltigen UEberlegungen bei der Festlegung geeigneter Stichprobengroessen und helfen so bei der Planung von Studien. Bereitgestellt werden ebenfalls Stichprobentabellen mit Erlauterungen und aussagekraftige Beispiele auf der Basis von Echtdaten. Daruber hinaus enthalt das Fachbuch ein Literaturverweise und Angaben zu weiterfuhrenden Referenzen zur Unterstutzung der vorgestellten Prinzipien. Diese uberarbeitete 4. Auflage - ist das bislang einzige Referenzwerk mit einem Softwareprogramm fur die Gestaltung und Planung klinischer Studien. - enthalt neue und erweiterte Kapitel mit einer Vielzahl neuer und aktualisierter Beispiele. - erlautert verstandlich die angewandten Prinzipien und Methoden anhand von Beispielen aus der Praxis. - prasentiert auf nachvollziehbare Weise ein komplexes und dennoch wichtiges Thema, damit die richtigen Methoden verwendet werden und fundierte Ergebnisse veroeffentlicht werden koennen. - bietet Hilfestellung von einem Team international anerkannter Statistikexperten im medizinischen Bereich. Sample Sizes for Clinical, Laboratory and Epidemiology Studies richtet sich an medizinische Forscher aller Disziplinen sowie an Medizinstatistiker. Die aktualisierte 4. Auflage ist ein wichtiges Referenzwerk fur die Gestaltung und Planung verlasslicher, evidenzbasierter klinischer Studien.

The Role of Information Professionals in the Knowledge Economy: Skills, Experiences, Practices and Strategies presents the tools that are necessary for the acquisition and development of a scientific culture. The work and profile of the information professional is no longer limited to the world of libraries. In countries with developing and peripheral economies that are seeking to reduce dependence on knowledge generated by rich countries it is necessary to develop and foster new professional profiles with high expertise in knowledge generation and management in order to support such paradigm shifts. This comprehensive book presents the case for this paradigm shift and is an ideal resource for information professionals who are interested in new avenues of exploration.

Randomised 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 Randomised 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.

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 areasDescribes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fieldsAdditional 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 areaNewly 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 networkAn 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.

Well received in its first edition, "Survival Analysis: A Practical Approach" is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments.

Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models.

During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.

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.