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
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
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