Dr Vishal C. Patel
Vishal’s clinical sessions include delivery of care for patients with all types and severities of liver diseases, with a particular interest in advanced chronic liver disease and portal hypertensive complications. He is skilled in managing refractory variceal bleeding, is a JAG accredited endoscopy trainer and is dedicated to improving the outcomes of patients with cirrhosis by advancing standards of care and undertaking translational clinical trials. Vishal is also a Principal Investigator at the Foundation for Liver Research, focusing on investigating the gut-liver axis in cirrhosis in order to develop novel therapeutic interventions that can target these areas.
Chief Scientific Investigator:
Dr Mark J. W. McPhail
Mark is a Senior Lecturer and Consultant in Liver Critical Care and Hepatology in the Institute of Liver Studies, King’s College London. His main research interests are in outcome prediction, metabolism and immunity in liver failure syndromes. He is the Chief Scientific Investigator of the BOPPP study.
His present focus is on using metabolic profiling to improve prognostication and find novel pathways for metabolic modulation of innate immune responses through the action of lipids on CD14+ monocytes in patients with acute and acute-on-chronic liver failure. He will lead on the mechanistic sub study to BOPPP MBOP (Mechanism of beta-blockade on portal hypertension.)
Clinical Trial Manager, KCH
I am a Biomedical Sciences graduate from University College London (UCL) with an interest in coordinating clinical trials and helping to improve patient care.
I am the main point of contact for all internal and external stakeholders. I work alongside many devoted healthcare professionals across the UK but predominantly, the Chief Investigator, Chief Scientific Investigator and Trial Assistant on the day-to-day management and coordination of the trial.
I and the trial management team are here to support all the BOPPP teams in whatever way we can.
Ben Carter is the lead methodologist for the BOPPP trial to ensure the trial design, data quality, completeness and accuracy. He is the King’s Clinical trials unit (KCTU) mental health group lead, and has been involved running clinical trials for over 20 years. He has personal interests in the evaluation of technology on health and is the methodological lead on 10 clinical trials.
Ben holds a BSc in Statistics from Reading University, MSc in Medical Statistics from Southampton University (2001) and PhD from Reading University (2005).
Hassan joined the Department of Biostatistics and Health Informatics, King’s College London as a statistician, working primarily on the set up, conduct and analysis of clinical trials supported by the King’s Clinical Trials Unit. In 2017 he completed a Master of Sciences in Quantitative Analysis in Social Sciences (University of Leuven, Belgium) and he is now finishing a PhD in Health Psychology (University of Leuven, Belgium). He is interested in application of multilevel regression models, meta analysis and psychometrics in health and medical research. From early 2019, he joined the BOPPP trial management team to provide data and statistical support.
Lead Health Economist
James Shearer is a senior lecturer in health economics at King’s Health Economic and the methods lead for Health Economics and Innovation at the Research Design Service, London. He has extensive experience of undertaking economic evaluations alongside clinical trials. His interests are the use of economic modelling methods to extrapolate cost and outcome data beyond the time horizons of clinical trials to capture longer term costs and benefits of treatments. He will lead the economic evaluation of BOPPP. This will include a within trial comparison of costs and quality adjusted life years (QALYs) between the intervention and the comparator, and a comparison of over a lifetime horizon using a bespoke decision analytical model.
Former Lead Health Economist
Renee Romeo’s current research emphases are primarily dementia, child and adult mental health, autism, intellectual disabilities, global health; all of this work has an economic focus, and in all of it she seeks to tease out mainly the practice and also the policy implications.
Health Economist Research Fellow
Nahel Yaziji joined King’s College London (KCL) in 2021 as a research associate. He is a qualified pharmacist and holds an MSc in Public Health. He obtained training on economic evaluation, decision modelling and financial mathematics. He works on the economic evaluation component of various projects.
Former Lead Health Economist
Mark Pennington is a senior lecturer in health economics and deputy head of King’s Health Economics. He also leads the health economics team at King’s Technology Evaluation Centre (KiTEC), who undertake assessment work for the National Institute of Health & Care Excellence (NICE). He has extensive experience of undertaking economic evaluation alongside clinical trials. His interests lie in the extrapolation of event data to support modelling of costs and effects of interventions over a longer time horizon. He will lead the economic evaluation of BOPPP. This will encompass a ‘within trial’ comparison of costs and quality adjusted life expectancy between the treatment and comparator, and a comparison over a lifetime horizon based upon a bespoke decision model.
Lead Qualitative Researcher
Vanessa is a Senior Lecturer in Qualitative Social Sciences at King’s College London with expertise in applying qualitative methodologies in health research. She is interested in using qualitative methods to develop and evaluate healthcare programmes and complex interventions that are grounded in the priorities of service users. Vanessa is affiliated with the King’s Clinical Trials Unit and provides expert advice on applying qualitative methods in clinical trials across King’s Health Partners.
Clair works as a qualitative research fellow and brings qualitative expertise to the trial. Clair is an occupational therapist by background, and has also worked in health services research for ten years. Prior to her role with BOPPP, Clair conducted qualitative research in mental health services and cancer services, with patients, clinical staff and senior NHS leaders. Clair’s work in BOPPP will explore the barriers and facilitators to trial recruitment, as well factors that might influence the success of BOPPP implementation beyond the trial.
South London CRN Study Support Service Specialist
I support the development, set-up, & delivery of NHS and non-NHS research across south London. Presently, I am the region’s COVID-19 BAME Champion and I am contributing to a number of national initiatives, including work on managing adoption in relation to the MHRA/HRA Combined Ways Of Working (CWOW) programme.
Previously I managed a number of ethics committees for the National Research Ethics Service, acted as Senior Confidentiality Advisor to the Health Research Authority – where I also project managed a number of national initiatives to streamline research permissions, & worked as a research facilitator at King’s College Hospital.
I am a Clinical Trials Pharmacist at the King’s Clinical Trials Unit (KCTU). My role is to primarily support Chief Investigators with the management of investigational medicinal products (IMP) for blinded drug trials. This is achieved through the development of IMP management plans, liaising with manufacturers to ensure timely availability of the IMP and placing IMP orders for sites. For the BOPPP trial my main role is ensure continuity of IMP supply to sites through regular unblinded monitoring of the KCTU intervention management system. I report to the TMG quarterly, where I provide IMP stock level details (held centrally and at sites) and advise on the quantities to ship to trial sites and when to schedule manufacturing runs. I also support the development and review of IMP documents for the pharmacy file.
Jinsun (Jinny) Yoo
I am the BOPPP clinical research associate (CRA) working with the King’s Health Partners Clinical Trials Office. My role is to monitor the BOPPP trial on behalf of the sponsor to ensure regulatory compliance. As a CRA, I am the first point of contact between sites and the sponsor regarding any queries or advice they may need, and I provide support to investigators to ensure the conduct of the BOPPP trial. I also perform monitoring visits and report on the progress of the trial across all the sites.
Former Trial Manager
Dr Kieran Brack
I am a scientist by training with an established background in clinical research including medical devices, imaging and technology, and medicinal products (‘drug’ studies).
A number of things impressed me about the BOPPP trial. Firstly, the trial team are a fantastic group of bright and dedicated researchers that are incredibly passionate about developing better healthcare for patients with liver disease. Secondly, this group have developed a pragmatic trial design with patient involvement at the heart of every decision, so participation is aligned to standard care reducing the burden for patients.