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.
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)
