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Overview
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.
Synopsis
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.
Doody Review Services
Reviewer:Alfred H Kim, MD, PhD(Washington University Medical Center)
Description: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.
Purpose:This book outlines parameters that have been successful in generating the important clinical trials in both 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.
Audience:The suggested audience includes principle investigators, pharmaceutical physicians, and staff involved in the design and interpretation of clinical trials. While most rheumatologists may find the first several chapters redundant as they outline current rheumatoid arthritis and osteoarthritis therapeutic approaches, the remaining chapters succinctly outline study design, clinical endpoint generation, collection and interpretation of data, and use of imaging and laboratory resources. For those without any formal training in clinical research, this book does the trick.
Features:The book covers all major necessary research requisites for designing and maintaining clinical trials. The first quarter of the book focuses on historical background of previous and current therapies used for rheumatoid arthritis and osteoarthritis. It then quickly examines the various study designs used by successful trials. Severalchapters are dedicated to the day-to-day running of trials with emphasis on data collection. The authors describe how to organize and interpret the data for peer-reviewed quality figures. Finally, the book examines laboratory and radiologic endpoints, with speculation of novel endpoints in pharmacogenomics and pharmacoeconomics. The organization is thoughtful, and the chapters are well written with a comfortable flow. Worth highlighting is the data analysis section with its easy to understand explanations of common statistical approaches. Also unique are the sections describing ethical considerations for clinical trial design.
Assessment:This is one of the first books to describe the process of designing and executing clinical trials for rheumatoid arthritis and osteoarthritis. While the book may not completely outline every needed detail, the references direct readers to more in-depth information. I found this book effective not only in generating the foundation for performing trials, but also for better understanding the limitations of published trials. Certainly, it's a worthy read for those interested in clinical research.
Editorials
From The Critics
Reviewer: Alfred H Kim, MD, PhD(Washington University Medical Center)Description: 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.
Purpose: This book outlines parameters that have been successful in generating the important clinical trials in both 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.
Audience: The suggested audience includes principle investigators, pharmaceutical physicians, and staff involved in the design and interpretation of clinical trials. While most rheumatologists may find the first several chapters redundant as they outline current rheumatoid arthritis and osteoarthritis therapeutic approaches, the remaining chapters succinctly outline study design, clinical endpoint generation, collection and interpretation of data, and use of imaging and laboratory resources. For those without any formal training in clinical research, this book does the trick.
Features: The book covers all major necessary research requisites for designing and maintaining clinical trials. The first quarter of the book focuses on historical background of previous and current therapies used for rheumatoid arthritis and osteoarthritis. It then quickly examines the various study designs used by successful trials. Several chapters are dedicated to the day-to-day running of trials with emphasis on data collection. The authors describe how to organize and interpret the data for peer-reviewed quality figures. Finally, the book examines laboratory and radiologic endpoints, with speculation of novel endpoints in pharmacogenomics and pharmacoeconomics. The organization is thoughtful, and the chapters are well written with a comfortable flow. Worth highlighting is the data analysis section with its easy to understand explanations of common statistical approaches. Also unique are the sections describing ethical considerations for clinical trial design.
Assessment: This is one of the first books to describe the process of designing and executing clinical trials for rheumatoid arthritis and osteoarthritis. While the book may not completely outline every needed detail, the references direct readers to more in-depth information. I found this book effective not only in generating the foundation for performing trials, but also for better understanding the limitations of published trials. Certainly, it's a worthy read for those interested in clinical research.