This 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. Further, it provides a background on regulatory guidelines, ethical implications, endpoints, current therapies and the ideal drug to use. This book serves as a practical manual for clinicians and scientists new to the subject and provides a standard for existing centers to measure themselves against.
Rezensionen / Stimmen
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)
"This is a practical and well illustrated handbook covering over four chapters 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 osteoporosis." (P. Delincé, Acta Orthopaedica Belgica, Vol. 71 (1), 2005)
"The . book covers all nowadays aspects of performing clinical trials in osteoporosis (OP). . 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 OP clinical trials. . I would strongly recommend the purchase and use of this book which does notreally have any counterpart in the available literature on the subject." (Daniel Uebelhart, Zeitschrift für Rheumatologie, Vol. 62 (2), 2003)
Sprache
Verlagsort
Verlagsgruppe
Illustrationen
58
58 s/w Abbildungen
XIII, 258 p. 58 illus.
Dateigröße
ISBN-13
978-1-4471-3710-8 (9781447137108)
DOI
10.1007/978-1-4471-3710-8
Schweitzer Klassifikation
1. Introduction.- Section 1: Study Design and the Pre-trial Phase.- 2. Study Design and Endpoints.- 3. Ethical Considerations.- 4. Standardization and Pre-trial Quality Control.- Section 2: Performing the Trial.- 5. Organization of the Clinical Trial by the Sponsor.- 6. Local Site Organization.- 7. Clinical Trial Quality Assurance.- 8. Laboratory and Instrument Quality Control.- Section 3: Data Analysis and Presentation.- 9. Data Analysis and Presentation: Writing a Paper for Publication.- Section 4: Background.- 10. Current and Future Therapies for Osteoporosis.- 11. The Ideal Drug for the Treatment of Osteoporosis.- 12. Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints.- 13. Biochemical Markers of Bone Turnover.- 14. Future Therapies and Clinical Trials.- Appendix A: Glossary.- Appendix B: Sample Data from the Example Study Used in this Book.
