Clinical Trials in Rheumatoid Arthritis and Osteoarthritis

ISBN-13: 9781852338749 / Angielski / Miękka / 2008 / 328 str.

David M. Reid; Collin G. Miller; Krishan Baburaj

Opis

Designed to be a practical handbook on clinical trial management in these key therapeutic areas, 'Clinical Trials in Rheumatoid Arthritis and Osteoarthritis' is aimed at principal investigators pharmaceutical physicians and other pharmaceutical staff involved in the design, conduct and monitoring of these increasingly complex diseases. In the last several years a new classes of biologic agents have emerged and changed the treatment paradigm for patients, not only with classically defined rheumatoid arthritis, but also with other related diseases such as ankylosing spondylitis and psoriatic arthritis. Furthermore, osteoarthritis is a major disease state that is often treated by the rheumatologist, but is one where patient management programs are currently limited with a need for new therapeutic approaches. In both inflammatory and non-inflammatory arthritic conditions, clinical trials have become both large and complex due to the nature of the diseases, with ever-challenging new surrogate end-points being employed. Topics covered in this title will therefore include study design, clinical endpoints, technical issues, data collection, use of centralized medical image reading facilities and biochemical marker laboratories, as well as data analysis and future therapies. This book takes the user through the process step-by-step from start to finish, also providing a background on the regulatory guidelines, ethical implications, endpoints, and current therapies.

Recenzje

This unique addition to the field of rheumatology focuses on the elements critical for the design and management of clinical trials in rheumatoid arthritis and osteoarthritis...The authors do an excellent job of breaking down how prominent clinical trials designed endpoints, collected and analyzed data, and avoided regulatory hurdles so readers can initiate trials of their own.  This is a worthwhile read for those interested in performing clinical trials in either disease...For those without any formal training in clinical research, this book does the trick.

-Doody's, reviewed by Alfred H. Kim, PhD (Washington University Medical Center)

Spis treści

Introduction.- Historical and Current Perspectives on Management of Osteoarthritis and Rheumatoid Arthritis.- Current and Some Future Biological Therapies used in Inflammatory Arthritis.- Study Design and Endpoints for Rheumatoid Arthritis Trials.- Study design and endpoints in AS clinical trials.- Trial design and Outcomes in Osteoarthritis.- Ethical Considerations.- Organization of the Clinical Trial by the Sponsor.- The Organisation of the Trial at the Investigator Site.- The Role of the Imaging Core Lab in Rheumatoid Arthritis and Osteoarthritis Clinical Trials.- Biochemical Markers of Rheumatoid Arthritis and Osteoarthritis: Clinical Utility and Practical Considerations.- Data Analysis and Presentation: Writing a Paper for Publication.- Radiographic Imaging Endpoints in Rheumatoid Arthritis Trials.- Radiography in Clinical Trials Investigating Osteoarthritis.- Use of Quantitative Magnetic Resonance Imaging (qMRI) in the Cross-sectional and Longitudinal Evaluation of Structural Changes in Knee Osteoarthritis Patients.- Biochemical Markers as Surrogate Endpoints of Joint Disease.- Role of Genetics and Genomics in Clinical Trials in Osteoarthritis and Rheumatoid Arthritis.- Cost-Effectiveness of New Biologics for Rheumatoid Arthritis and Osteoarthritis