Download Clinical Trials in Rheumatoid Arthritis and Osteoarthritis 2008th Edition PDF

Download Clinical Trials in Rheumatoid Arthritis and Osteoarthritis 2008th Edition PDF
by David Reid (Editor), Colin Miller (Editor)

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

Contributors…………………………………………….. vii
1 Introduction…………………………………………… 1
David M. Reid and Colin G. Miller
2 Historical and Current Perspectives on Management of
Osteoarthritis and Rheumatoid Arthritis…………………….. 5
Shirish Dubey and Adewale O. Adebajo
3 Development of Biological Therapies for Inflammatory Arthritis….. 37
Neil Basu
4 Study Design and End Points for Rheumatoid Arthritis Trials……. 51
Pieter Geusens and Colin G. Miller
5 Study Design and End Points in Ankylosing Spondylitis
Clinical Trials………………………………………….. 69
Désirée van der Heijde
6 Trial Design and Outcomes in Osteoarthritis………………….. 81
Nigel Arden
7 Ethical Considerations…………………………………… 91
Derek Pearson and Colin G. Miller
8 Organization of the Clinical Trial by the Sponsor ………………113
Colin G. Miller
9 Organization of the Trial at the Investigator Site……………….123
Julie Shotton, David M. Reid, and Colin G. Miller
10 Role of the Imaging Core Laboratory in Rheumatoid Arthritis and
Osteoarthritis Clinical Trials……………………………….135
Mark D. Endres and Anna M. Baratelle
11 Biochemical Markers of Rheumatoid Arthritis and Osteoarthritis:
Clinical Utility and Practical Considerations…………………..151
Mario R. Ehlers and Elizabeth T. Leary
v
vi Contents
12 Data Analysis and Presentation: Writing a Paper for Publication ….171
Derek Pearson
13 Radiographic Imaging End Points in Rheumatoid Arthritis Trials….201
Anna M. Baratelle and Désirée van der Heijde
14 Radiography in Clinical Trials Investigating Osteoarthritis……….223
Cornelis van Kuijk
15 Use of Quantitative Magnetic Resonance Imaging in the
Cross-Sectional and Longitudinal Evaluation of Structural Changes
in Knee Osteoarthritis Patients……………………………..235
Jean-Pierre Raynauld, Johanne Martel-Pelletier, François Abram,
and Jean-Pierre Pelletier
16 Biochemical Markers as Surrogate End Points of Joint Disease……249
L. Stefan Lohmander and David R. Eyre
17 Role of Genetics and Genomics in Clinical Trials in Osteoarthritis
and Rheumatoid Arthritis…………………………………275
Stuart H. Ralston
18 Cost-Effectiveness of New Biologics for Rheumatoid Arthritis
and Osteoarthritis……………………………………….289
Yolanda Bravo Vergel and David Torgerson
Abbreviations………………………………………………309
Index …………………………………………………….311

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