Clinical Trials and Tribulations

Gayathri De Lanerolle, Peter Phiri, Athar Haroon

• Publisher: Academic Press
• Year: 2023
• Print ISBN:
  9780128217870
• eBook ISBN:
  9780128217887
• Topic: Medicine
• Subtopic: Medical Theory, Practice & Reference

Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials. - Covers key topics across pre-clinical, clinical research and clinical practice - Highlights areas such as the socioeconomics of conducting research, capacity and capability, research quality and performance (including performance indicators, adaptive design and practical solutions) - Provides lessons learned from breach of protocols, ethical breaches, SAE/SUSARs, aseptic pharmacy preparation issues, and instability within research structures - Includes a focus on the UK clinical research system, offering key insights into working within the UK and collaborating with UK partners

Table of contents

• Clinical Trials and Tribulations
• 1 The clinical research landscapes
• 2 Clinical trials and epidemiology studies
• 3 Principles of medical statistics
• 4 Research ethics and supporting evolving research
• 5 Primary and secondary care research
• 6 Data science and clinical informatics
• 7 Organisational structure and research readiness
• 8 Research capacity and capability
• 9 Research waste
• 10 Research operations management
• 11 Research governance and compliance management
• 12 Audits and inspections
• 13 Patients and public support
• 14 Dissemination and implementation
• 15 The future of clinical research
• Index