000 04383nam a22005175i 4500
001 978-1-84628-742-8
003 DE-He213
005 20161121230843.0
007 cr nn 008mamaa
008 100301s2008 xxk| s |||| 0|eng d
020 _a9781846287428
_9978-1-84628-742-8
024 7 _a10.1007/978-1-84628-742-8
_2doi
050 4 _aRC927-927.5
072 7 _aMJM
_2bicssc
072 7 _aMED083000
_2bisacsh
082 0 4 _a616.723
_223
245 1 0 _aClinical Trials in Rheumatoid Arthritis and Osteoarthritis
_h[electronic resource] /
_cedited by David M. Reid, Colin G. Miller.
264 1 _aLondon :
_bSpringer London,
_c2008.
300 _aVIII, 328 p. 54 illus., 24 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aClinical Trials
505 0 _aHistorical and Current Perspectives on Management of Osteoarthritis and Rheumatoid Arthritis -- Development of Biological Therapies for Inflammatory Arthritis -- Study Design and End Points for Rheumatoid Arthritis Trials -- Study Design and End Points in Ankylosing Spondylitis Clinical Trials -- Trial Design and Outcomes in Osteoarthritis -- Ethical Considerations -- Organization of the Clinical Trial by the Sponsor -- Organization of the Trial attheInvestigator Site -- Role of the Imaging Core Laboratory 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 End Points in Rheumatoid Arthritis Trials -- Radiography in Clinical Trials Investigating Osteoarthritis -- Use of Quantitative Magnetic Resonance Imaging in the Cross-Sectional and Longitudinal Evaluation of Structural Changes in Knee Osteoarthritis Patients -- Biochemical Markers as Surrogate End Points 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.
520 _aDesigned 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.
650 0 _aMedicine.
650 0 _aPharmacology.
650 0 _aMetabolic diseases.
650 0 _aRheumatology.
650 0 _aOrthopedics.
650 1 4 _aMedicine & Public Health.
650 2 4 _aRheumatology.
650 2 4 _aPharmacology/Toxicology.
650 2 4 _aMetabolic Diseases.
650 2 4 _aOrthopedics.
700 1 _aReid, David M.
_eeditor.
700 1 _aMiller, Colin G.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781852338749
830 0 _aClinical Trials
856 4 0 _uhttp://dx.doi.org/10.1007/978-1-84628-742-8
912 _aZDB-2-SME
950 _aMedicine (Springer-11650)
999 _c504945
_d504945