: David M. Reid, Colin G. Miller
: David Reid, Colin Miller
: Clinical Trials in Rheumatoid Arthritis and Osteoarthritis
: Springer-Verlag
: 9781846287428
: 1
: CHF 74.40
:
: Klinische Fächer
: English
: 328
: Wasserzeichen/DRM
: PC/MAC/eReader/Tablet
: PDF

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.

 

n 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.

 

opics 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.

Contents6
Contributors8
Introduction10
Why a Book About Clinical Trials in Rheumatoid Arthritis and Osteoarthritis?10
How This Book Works11
References12
Historical and Current Perspectives on Management of Osteoarthritis and Rheumatoid Arthritis14
Historical and Current Perspectives on Management of Osteoarthritis14
Historical Aspects15
Predisposing Factors15
Pathogenesis15
Treatment of OA16
Nonpharmacological Therapies16
Pharmacological Therapy16
Surgical Treatments20
Summary21
Historical and Current Perspectives on Management of Rheumatoid Arthritis21
Evolutional History of Pharmacotherapeutics in RA22
Initial Assessment of Patients with RA24
Further Management of RA Patients24
Nonpharmacological Treatment of RA25
Pharmacological Treatment of RA26
Surgical Treatment of RA34
Summary35
References35
Development of Biological Therapies for Inflammatory Arthritis46
Tumor Necrosis Factor-46
for Rheumatoid Arthritis46
Ankylosing Spondylitis48
Psoriatic Arthritis49
Juvenile Idiopathic Arthritis49
Safety Considerations49
Economic Considerations50
The Future51
Other Biological Agents51
References56
Study Design and End Points for Rheumatoid Arthritis Trials60
Introduction60
Patient Selection64
Types of Clinical Trials65
End Points67
Single End Points68
Composite Measures71
Adverse Events75
Conclusion75
References76
Study Design and End Points in Ankylosing Spondylitis Clinical Trials78
Introduction78
Study Design78
Scope of Patients81
Type of End Points to Consider82
Instruments for Various End Points83
Assessment of Response/Improvement86
Conclusion87
References87
Trial Design and Outcomes in Osteoarthritis90
Introduction90
Study Design90
Scientific versus Pragmatic Trials91
Study Duration92
Patient Selection92
Control Arm93
Sample Size95
Outcome Assessment95
Compliance97
Statistics97
Presentation and Dissemination98
Study Organization98
Conclusion98
References99
Ethical Considerations100
Introduction100
Who Does What?101
Sponsorship: Who’s Paying the Bill?101
Placebo or Not Placebo?102
Randomization103
Who Can Take Part?104
Trial Procedures105
Ethical Review109
Informed Consent111
Dissemination113
Conclusion113
References113
Appendix 1115
What Is the Purpose of the Study?115
Why Have I Been Chosen?115
Do I Have to Take Part?115
What Will Happen to Me if I Take Part?115
What Do I Have to Do?116
What Is the Drug That Is Being Tested?117
What Are the Alternatives for Treatment?117
What Are the Side Effects of Taking Part?117
What Are the Possible Disadvantages and Risks of Taking Part?117
What Are the Possible Benefits of Taking Part?117
What if the New Information Becomes Available?118
What Happens When the Research Study Stops?118
What if Something Goes Wrong?118
Will My Taking Part in This Study Be Kept Confidential?118
What Will Happen to the Results of the Research Study?119
Who Is Organizing and Funding the Research?119
Contact for Further Information119
Appendix 2120
Organization of the Clinical Trial by the Sponsor122
Introduction122
Regulatory Guidance122
Surrogate Markers123
Couriers125
Investigator Meetings125
Cross-Calibration of Scanners126
Inclusion and Exclusion Criteria127
Data Flow127
The Data Monitoring Committee128
Trial Audit129
Trial Closure130
Conclusion130
References130
Organization of the Trial at the Investigator Site132
Introduction132
Site Resources133
Study Budget and Clinical Trial Agreement134
Ethics IRB and Informed Consent135
Study Initiation and Conduct136
Handling of Blood Samples: Central versus Local Laboratories137
Pharmacy138
Recruitment Methods138
Monitoring Adverse Events139
Informed Consent140
Subject Retention and Compliance141
Advocacy141
Study Closeout142
Conclusion142
References143
Role of the Imaging Core Laboratory in Rheumatoid Arthritis and Osteoarthritis Clinical Trials144
Introduction144
The Imaging Core Laboratory144
Conclusion158
References158
Biochemical Markers of Rheumatoid Arthritis and Osteoarthritis: Clinical U