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Clinical Trials in Osteoporosis: Clinical Trials

Editat de Derek Pearson, Colin G. Miller
en Limba Engleză Paperback – 19 apr 2007
COLING. MILLER ANDDEREKPEARSON 1. 1. Why a Book about Clinical Trials in Osteoporosis? There have been many books published about the design, conduct, and analysis of clinicaltrials. Whyareosteoporosistrialsaspecialcasethatdeserveabookoftheir own? There are three main reasons. First, most diseases have a well-understood definitionandaetiology. Osteoporosisisadiseasethatisunderstoodbythosewo- ing within the subspecialty, but currently there is no definition that is agreeable to both medical and scientific communities and its aetiology is poorly understood. It is within this framework that the pharmaceutical industry is trying to develop new treatmentsfortheso-called“silentepidemic”. In layman’s terms, the disease of osteoporosis is defined as “brittle bones occurring in the elderly that could lead to fractures. ”The classical definition was “a bony fracture caused by minimal trauma owing to a loss in bone mineral. ” A published consensus definition states that osteoporosis is “a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to 1 fractures. ” The National Institutes of Health (NIH) Consensus Conference Statement on Osteoporosis Prevention, Diagnosis, and Therapy states that “osteoporosis is a skeletal disorder characterized by compromised bone strength 2 predisposing to an increased risk of fracture. ” The World Health Organization (WHO) operationally defines osteoporosis as “bone density 2. 5 standard dev- tions (SDs) below the mean for young white adult women at lumbar spine, 3 femoralneck,orforearm”. Itisnowrecommendedthatthediagnosticuseofthis 4 definition is restricted to bone density of the femur.
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Specificații

ISBN-13: 9781846283895
ISBN-10: 1846283892
Pagini: 292
Ilustrații: X, 292 p. 50 illus.
Dimensiuni: 155 x 235 x 12 mm
Greutate: 0.53 kg
Ediția:2nd ed. 2007
Editura: SPRINGER LONDON
Colecția Springer
Seria Clinical Trials

Locul publicării:London, United Kingdom

Public țintă

Research

Cuprins

Study Design and the Pretrial Phase.- Study Design and Endpoints.- Ethical Considerations.- Standardization and Pretrial Quality Control.- Performing the Trial.- Organization of the Clinical Trial by the Sponsor.- Local Site Organization.- Clinical Trial Quality Assurance.- Laboratory and Instrument Quality Control.- Data Analysis and Presentation.- Data Analysis and Presentation: Writing a Paper for Publication.- Background.- Current Therapies for Osteoporosis.- The Ideal Drug for Treatment of Osteoporosis.- Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints.- Biochemical Markers of Bone Turnover.- Future Therapies and Clinical Trials.

Recenzii

From the reviews:
This book is a practical bench support for all people involved in clinical research dealing with osteoporosis. The book is well designed, easy to read and easy to address as a reference for all aspects regarding osteoporosis and clinical trials in osteoporosis. The quality control regarding both organizational, technical and clinical aspects up to publication of the results of the trials are thoroughly developed in the book. This book … does not really have any counterpart in the available literature on the subject. The target audience of the book appears to be very large … and includes industry partners and sponsors, members of CROs and CRAs and monitors, clinical investigators, physicians and technical staff, clinical trial nurses and other members of the non medical staff involved in a trial related to osteoporosis. (Daniel Uebelhart, Zeitschrift für Rheumatologie 2003;63(2);208.)
This is a practical and well illustrated handbook covering all aspects of clinical trials in the field of osteoporosis. The book is of special interest for everyone planning to conduct research in the specific field of osteporosis. (P. Delincé, Acta Orthopaedica Belgica 2005; 71(1),128)
From the reviews of the second edition:
"A practical manual for clinicians planning and/or participating in trials of osteoporosis treatment. Actually the trials are designed by the manufacturers of the drugs. They also evaluate and usually analyze the data. This book is designed to help the researchers to check whether the protocol is correct and safe. Last but not least, a useful text for pharma." (Zvi Laron, Pediatric Endocrinology Reviews, Vol. 6 (3), March, 2009)

Textul de pe ultima copertă

The second revised and updated edition of Clinical Trials in Osteoporosis is a practical handbook on clinical trials in the growing field of osteoporosis. Topics covered include study design, technical issues, data collection, quality assurance, data analysis and presentation. It takes the user through the process step-by-step from start to finish, also providing a background on regulatory guidelines, ethical implications, endpoints, current therapies and the ideal drug to use.
Clinical Trials in Osteoporosis is intended to serve as a practical manual for clinicians and scientists coming to the subject new and to provide a standard for existing centers to measure themselves against.

Caracteristici

A practical manual for clinicians/scientists coming to the subject new - provides a standard for existing centers to measure themselves against Specifically addresses clinical trials in osteoporosis (no such other book is in the Library of Congress Catalog) Combines a number of issues brought together for the first time Uniquely written both from the viewpoint of the technologist and the MD investigator as well as the pharmaceutical personnel In-depth coverage of Good Clinical Practice (GCP)