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.
1. Clinical Trials and Tribulations - p. i 2. Cover - p. i 3. Title Page - p. iii 4. Copyright Page - p. iv 5. Table of Contents - p. iv 6. 1 The clinical research landscapes - p. 1 7. 2 Clinical trials and epidemiology studies - p. 13 8. 3 Principles of medical statistics - p. 41 9. 4 Research ethics and supporting evolving research - p. 87 10. 5 Primary and secondary care research - p. 97 11. 6 Data science and clinical informatics - p. 111 12. 7 Organisational structure and research readiness - p. 153 13. 8 Research capacity and capability - p. 165 14. 9 Research waste - p. 181 15. 10 Research operations management - p. 187 16. 11 Research governance and compliance management - p. 215 17. 12 Audits and inspections - p. 219 18. 13 Patients and public support - p. 233 19. 14 Dissemination and implementation - p. 241 20. 15 The future of clinical research - p. 255 21. Index - p. 259
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.
1. Clinical Trials and Tribulations - p. i 2. Cover - p. i 3. Title Page - p. iii 4. Copyright Page - p. iv 5. Table of Contents - p. iv 6. 1 The clinical research landscapes - p. 1 7. 2 Clinical trials and epidemiology studies - p. 13 8. 3 Principles of medical statistics - p. 41 9. 4 Research ethics and supporting evolving research - p. 87 10. 5 Primary and secondary care research - p. 97 11. 6 Data science and clinical informatics - p. 111 12. 7 Organisational structure and research readiness - p. 153 13. 8 Research capacity and capability - p. 165 14. 9 Research waste - p. 181 15. 10 Research operations management - p. 187 16. 11 Research governance and compliance management - p. 215 17. 12 Audits and inspections - p. 219 18. 13 Patients and public support - p. 233 19. 14 Dissemination and implementation - p. 241 20. 15 The future of clinical research - p. 255 21. Index - p. 259
