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Book Detail
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Clinical Trial Management: An Overview
Sahoo, Umakanta
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Status: Publication Cancelled Imprint: Woodhead Publishing
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Synopsis:
Clinical research is a complex but systematic process that follows a series of steps, rigid standard protocols, rules and regulations, set and governed by the competent regulatory authorities in each country. The rules laid down by the competent authorities invariably demand the code of ethics by which every individual involved in clinical research has to abide. Besides these ethical principles, clinical trials involves multidisciplinary functions which require planning and management, using modern research tools and techniques. In this book, the authors discuss some of these key functions in clinical trial management viz. clinical operations, project management, regulatory affairs, quality assurance, pharmacovigilance, medical affairs, and the processes involved in performing these functions for the successful running of a clinical study. This book is a an overview of the subject, designed to show the various activities that are involved in clinical trials and understand their processes, which are essential for planning and implementing a successful clinical trial. This book also facilitates the understanding of the importance of ethics in clinical studies and the evolution of various guidelines, rules and regulations for the management of a clinical trial. Recruitment and retention of valuable patients are critical to the success of a clinical trial and hence pose a large number of challenges for the management team to complete the trial in multiple countries with the desired number of patients enrolled in time. This book also helps readers to understand the strategies to tackle issues like enrolment of a special population, cultural and socio-economic and language issues that act as a potential barrier in clinical trial management.
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