Fundamental Concepts for New Clinical Trialists

Fundamental Concepts for New Clinical Trialists is a book that provides a foundation for understanding the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials. It defines and compares clinical trials to other types of research studies, discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. The second section examines scientific issues faced in each progressive step of a clinical trial, including trial design, data monitoring, analyses of efficacy, safety, and benefit-risk, and the reporting/publication of clinical trial results.

Format: Paperback / softback
Length: 348 pages
Publication date: 31 March 2021
Publisher: Taylor & Francis Ltd

The Fundamental Concepts for New Clinical Trialists is a comprehensive guide that delves into the core scientific principles and practical considerations involved in designing, monitoring, analyzing, and reporting clinical trials. This book serves as a valuable resource for individuals who are embarking on their journey into the world of clinical research, providing them with a solid foundation of knowledge to tackle real-world issues at every stage of the trial process.

The first section of the book offers a comprehensive overview of clinical trials, defining them as research studies conducted to evaluate the effectiveness and safety of medical interventions. It compares clinical trials to other types of research studies and discusses the various phases, registration requirements, protocol documents, ethical considerations, product development, and regulatory processes involved in conducting clinical trials. Additionally, a special chapter is dedicated to outlining the valuable attributes that statisticians can develop to maximize their contributions to clinical trials.

The second section of the book focuses on the scientific issues that arise at each progressive step of a clinical trial. It covers topics such as trial design, including randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority comparisons, and parallel group versus crossover designs. Data monitoring is also discussed, including the responsibilities and procedures for monitoring trial data and identifying potential safety concerns. Efficacy, safety, and benefit-risk analyses are explored, along with the methods and tools used to evaluate and report clinical trial results.

As clinical trials continue to be the gold standard research studies for evaluating the effects of medical interventions, it is essential for newcomers to the field to have a fundamental understanding of the concepts necessary for working in clinical trials. The authors of this book, drawn from their extensive experiences in academia and industry, have provided a comprehensive foundation for understanding the fundamental concepts required for success in this field.

By covering a wide range of topics and providing detailed explanations, The Fundamental Concepts for New Clinical Trialists is an invaluable resource for researchers, healthcare professionals, students, and anyone interested in advancing their knowledge and expertise in clinical research. Whether you are a seasoned clinical trialist or just starting your journey, this book will help you navigate the complexities of clinical trials and contribute to the advancement of medical science and healthcare.

Weight: 680g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367783396