Clinical Trials and Tribulations
- 1st Edition - March 1, 2023
- Imprint: Academic Press
- Authors: Gayathri De Lanerolle, Peter Phiri, Athar Haroon
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 1 7 8 7 - 0
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 1 7 8 8 - 7
Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future direction… Read more
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Request a sales quoteClinical 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
- Cover image
- Title page
- Table of Contents
- Copyright
- 1: The clinical research landscapes
- Abstract
- 1.1: A brief history
- 1.2: The ‘clinical research’ revolution
- 1.3: Modern-day clinical research
- References
- Further reading
- 2: Clinical trials and epidemiology studies
- Abstract
- 2.1: Background
- 2.2: Clinical trials
- 2.3: Epidemiology
- 2.4: Epidemiology methodology
- References
- 3: Principles of medical statistics
- Abstract
- 3.1: Introduction
- 3.2: An overview of statistical methods
- 3.3: Epidemiology statistics
- 3.4: Disease mapping methods
- 3.5: Clinical trial statistics
- References
- 4: Research ethics and supporting evolving research
- Abstract
- 4.1: Introduction
- 4.2: Morality versus ethics
- 4.3: Evolving research ethics
- References
- 5: Primary and secondary care research
- Abstract
- 5.1: Introduction [1–11]
- 5.2: Evidence synthesis
- References
- Further reading
- 6: Data science and clinical informatics
- Abstract
- 6.1: Introduction
- 6.2: Clinical informatics [18–24]
- 6.3: Interoperability [25–27]
- 6.4: Electronic health records (EHRs)
- 6.5: Healthcare data regulations and governance
- 6.6: Imaging data science [49–60]
- 6.7: Big data
- References
- Further reading
- 7: Organisational structure and research readiness
- Abstract
- 7.1: Introduction
- 7.2: Structure and readiness for conducting research in the United Kingdom
- 7.3: Structure and readiness in academia versus the NHS
- References
- Further reading
- 8: Research capacity and capability
- Abstract
- 8.1: Background
- 8.2: Professional perspectives
- 8.3: Roles in clinical research
- References
- Further reading
- 9: Research waste
- Abstract
- 9.1: Background [1–6]
- 9.2: Addressing research waste
- References
- 10: Research operations management
- Abstract
- 10.1: Background
- 10.2: Peer review
- 10.3: Recruitment and retention of participants in clinical research
- 10.4: Challenges in recruitment and retention
- 10.5: Contextual factors
- 10.6: Participant factors
- 10.7: Research factors
- 10.8: Strategies to improve recruitment and retention
- 10.9: Participant-related barriers
- 10.10: Monetary compensation
- 10.11: Strategies to cultural and contextual barriers
- 10.12: Tackling research-related barriers
- 10.13: Recruitment methods
- 10.14: Informed consent
- 10.15: Participant information sheet (PIS)
- References
- Further reading
- 11: Research governance and compliance management
- Abstract
- 11.1: Background
- 11.2: Research governance
- 11.3: Research compliance management
- References
- Further reading
- 12: Audits and inspections
- Abstract
- 12.1: Background
- 12.2: Audits
- 12.3: Inspections
- References
- Further reading
- 13: Patients and public support
- Abstract
- 13.1: Background
- 13.2: Patient–public involvement (PPI)
- 13.3: Barriers to patient–public involvement
- 13.4: The future of patient–public involvement
- References
- 14: Dissemination and implementation
- Abstract
- 14.1: Background
- 14.2: Dissemination science
- 14.3: Implementation science
- References
- 15: The future of clinical research
- Abstract
- 15.1: Background
- 15.2: Use of existing evidence
- 15.3: Effectively addressing barriers
- 15.4: Maximising the digital landscape
- References
- Index
- Edition: 1
- Published: March 1, 2023
- Imprint: Academic Press
- No. of pages: 276
- Language: English
- Paperback ISBN: 9780128217870
- eBook ISBN: 9780128217887
GD
Gayathri De Lanerolle
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.
Affiliations and expertise
Digital Evidence Based Medicine LabPP
Peter Phiri
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, UKAH
Athar Haroon
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 Radionuclide Radiologist, St Bartholomew’s Hospital, London, United KingdomRead Clinical Trials and Tribulations on ScienceDirect