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
Staff working in clinical research within healthcare, academia and industry as well as research students; Clinical and specialist nurses, service managers, clinical operations manager and directors, finance directors and heads of finance, medical director, chief medical officers, physicians, junior doctors, ethics researchers, biological science researchers and university-based lecturers with a socio-economical and health and technology interest, clinical research associates, sales managers within medical device and drug companies attempting to introduce new therapies using the centralized procurement system in the UK
Table of Contents
1. Modern day clinical research landscape 2. Research Ethics and evolving research platforms 3. Primary care research 4. Organizational structure and research readiness 5. Capacity and Capability 6. Research waste 7. Research Operations Management 8. Research Governance and Compliance 9. Audits and Inspections 10. Patients and public support 11. Dissemination and implementation 12. Future of Clinical Research; management and practice
Dr. Gayathri De Lanerolle has worked in the clinical and academic domain for almost 2 decades. Her ongoing research publications involve an array of clinical trials and epidemiology studies in a variety of clinical areas. The author has over a decade of industry sponsored immunotherapy trial experience for a variety of cancers and, first-in-human clinical studies evaluating a variety of investigational medicinal products, medical devices and complex interventions. In addition, the author has experience in clinical leadership and research management.
Affiliations and Expertise
Clinical Researcher, University of Oxford, Oxford UK and Barts Health NHS Trust, London, UK
Dr Phiri completed his Diploma of Higher Education, Nursing in 2001 and his Bachelor of Science (Hons) in Nursing in 2002 from Kingston University. In 2007 he completed the Diploma in Cognitive Therapy for Severe Mental Health Problems with University of Southampton and gained accreditation with the British Association for Behavioural and Cognitive Psychotherapies (BABCP). Awarded BABCP Fellowship status for significant contributions in the field of Cognitive Behaviour Therapy in 2021. His keen interest in research stems from his first involvement in a pilot study providing Cognitive Behaviour Therapy (CBT) in a Primary Care setting to developing culturally adapted CBT for psychosis and the first UK based randomised controlled clinical trial of culturally adapted Cognitive Behavioural Therapy for Psychosis (CaCBTp) for ethnic minority communities. He was awarded his doctoral thesis at the University of Southampton in 2012. He continues to maintain his interest in culture and psychopathology with a focus on cultural adaptations of evidence based interventions for racially minoritised diverse populations and Global Health. He has been with the National Health Service (NHS) for over 20 years, and has gained extensive clinical experience and expertise in working with adults of working age with severe mental illness in varied clinical settings including inpatient, community and forensic settings. Visiting Fellow with University of Southampton, where he provide lectures to the Psychology programmes on CBT and cultural adaptions and academic supervision. He is also a visiting lecturer with Queen Mary University of London. Also a Fellow with the Pakistan Association for Cognitive Therapy (PACT). Contributions to advisory, leadership and review bodies include: European Association for Behavioural and Cognitive Psychotherapies (EABCT) Contributed to the Sofia Scientific Committee, Conference on the theme of Diversity and inclusion, (2018); British Association for Behavioural and Cognitive Psychotherapies (BABCP) Conference Advisory Group (formerly the Scientific Committee); Part of the UK Research & Development (UKRD) Summit organising Team. The UKRD is a professional community of R&D leaders across the NHS. NIHR Expert Portfolio Reviewer, this role entails reviewing eligibility of funded studies seeking adoption to the NIHR portfolio. An Academic Lead for the Clinical Record Interactive Search (CRIS) system at Southern Health NHS Foundation Trust within the Research & Innovation Department. A member of the BABCP Equality & Culture Specialist Interest Group. Recently appointed to Chair of the External Advisory Board to the School of Psychology, University of Southampton. Together with leading experts in the field Dr Phiri has published the book: Cultural Adaptation of CBT for Serious Mental Illness: A Guide for Training and Practice (2015) -A comprehensive guide designed to enable CBT practitioners to effectively engage people from diverse cultural backgrounds by applying culturally-sensitive therapeutic techniques. He is a peer reviewer for several journals including Schizophrenia Research; Behavioural and Cognitive Psychotherapy, Theory, Research and Practice, Behavioural and Cognitive Psychotherapy; The Cognitive Behaviour Therapy and BJPsychOpen; The Lancet Regional Health Western Pacific, JMIR etc. He has also published papers and book chapters in his area of expertise.
Affiliations and Expertise
Director of Research and Innovation, Southern Health NHS Trust, Southampton, UK and Cognitive Behavioral Therapy, Southampton University, UK
Dr. Athar Haroon is a Consultant Radionuclide Radiologist and has worked in an array of NHS organisations and academia, including United Lincolnshire Hospitals NHS Trust, University of Leicester, University Hospitals of Leicester NHS Trust, Nottingham University Hospitals NHS Trust, University College London Hospitals NHS Foundation Trust and University College London respectively. He has a special interest in hybrid imaging and utility of biomarkers for diagnosis, disease management and treatment of a variety of clinical areas including Neurology, Oncology, Endocrinology and Emergency Medicine. He has experience working with several biomarkers such as 18F FDG, 18F Choline, Ga 68 PSMA, Ga68 DOTATATE, and 18F Amyloid.
Affiliations and Expertise
Consultant Radiologist, Barts Health NHS Trust, London, UK