Clinical Trials and Tribulations: Navigating the Complexities of Research Management

Authored by Gayathri De Lanerolle, this book delves into the multifaceted layers of complexities surrounding research management, exploring current practices, challenges, and future directions in the realm of clinical trials.

A Pragmatic Approach to Research Management

Through the use of real-world examples, case studies, and lessons learned, Clinical Trials and Tribulations provides readers with practical solutions to real-world complex issues that have been documented by independent regulators. The book adopts an approach that balances pragmatic viewpoints with concepts and methodologies, aligning them with specific practices in academia, healthcare, and industry across the UK, Europe, and America.

Cutting Through the Complexity of Clinical Research

The book covers key topics across pre-clinical, clinical research, and clinical practice, shedding light on critical areas such as:

• The socioeconomics of conducting research
• Capacity and capability
• Research quality and performance, including performance indicators, adaptive design, and practical solutions
• Lessons learned from breach of protocols, ethical breaches, SAE/SUSARs, aseptic pharmacy preparation issues, and instability within research structures

With a focus on the UK clinical research system, Clinical Trials and Tribulations offers invaluable insights into working within the UK and collaborating with UK partners.

An Indispensable Resource for Clinical Research Professionals

This book is an essential guide for all staff working in clinical research within healthcare, academia, and industry, as well as students intending to work in clinical trials. By providing a comprehensive overview of the complexities and challenges in research management, Clinical Trials and Tribulations empowers readers with the knowledge and expertise needed to navigate the intricacies of clinical trials.

Publisher: Elsevier Science | Publication Date: March 1, 2023 | Language: English | ISBN: 9780128217870, 9780128217887