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"Clinical Trials Design and Methodology" is a comprehensive guide that covers the essential aspects of clinical trial design and implementation. The book delves into the fundamentals of trial design, including the importance of methodological rigor and historical developments. It explores various randomization techniques, the significance of blinding, and the different types of control groups. Readers will gain insights into calculating sample sizes, understanding trial phases, and selecting appropriate endpoints and outcome measures.
The book also addresses advanced statistical methods, identifying and minimizing bias, and effective data collection methods. Key chapters focus on monitoring and quality assurance, ethical and regulatory considerations, and special populations. Innovative trial designs, patient-centered outcomes, and strategies for reporting and dissemination are thoroughly examined. Through detailed case studies and an exploration of future trends, this book provides a valuable resource for anyone involved in clinical research.