Clinical Trials and Tribulations (eBook)

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

Gayathri Delanerolle is a Researcher. Her interests include women's health, artificial intelligence and chronic conditions with a special focus on disease sequalae. She has experience in evidence synthesis, epidemiology and mixed-methods research. Gayathri's experience in quality assurance inspired her to develop the content for this book and co-author with others with a special focus on complex healthcare areas that are rapidly evolving.

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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