Coordinating and delivering research in the pandemic: The UK approach

The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources.

It triggered a system-wide response which took the UK’s collaborative culture to new levels. This multi-agency approach enabled unprecedented speed and efficiency in trial approvals, set-up and recruitment. By eliminating delays and duplication, and optimising all available resources throughout our NHS, the UK was able to answer questions of global importance about COVID-19, including treatment and management.

Having successfully demonstrated our ability to coordinate, expedite and accelerate research delivery there is now an opportunity to reflect on what the UK did well and what this means for the future.

This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), took place on Thursday 25^th February 13:00 GMT / 14:00 CET and discussed the UK’s approach to delivering research during the COVID-19 pandemic. It examined lessons learnt from implementing complex design trials on a national scale and question what the UK could have done differently.

Focus

The webinar also covered:

• How research was prioritised
• Processes for streamlining approvals
• Learnings on site selection and set-up
• Strategies for successful and rapid recruitment

View the webinar* on demand by clicking on the link in the window above or by clicking here.

Our Panel

Phil Troke is Medical Director for Liver and COVID at Gilead Sciences UK & Ireland. He studied biochemistry before completing a Ph.D. at the University of Leicester and a postdoc in virology at Harvard Medical School. Phil's experience spans almost 15 years in pharmaceutical Research and Development and Medical Affairs with previous roles in Novartis, Pfizer and Johnson and Johnson. He joined Gilead in 2013, initially in a field medical role, and then taking positions within their UK and European teams. In 2018 he became Medical Director for the liver team, taking on the COVID medical lead role in March 2020.

Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA, having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials, particularly for Developmental Safety Update Reports (DSURs) and Reference Safety Information (RSI). She was also an EMA expert for the update of the First-in-Human guideline. Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this aspect for the MHRA in order to implement that aspect of the Life Sciences Industrial Strategy and was a contributor to the EU CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. More recently Kirsty has overseen the clinical trial work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the government Vaccine Taskforce.

Sir Terence Stephenson is an eminent clinical academic and took up the position of chair at the Health Research Authority on 1 September 2019. He is Nuffield Professor of Child Health at the University College London Great Ormond Street Institute of Child Health and Honorary Consultant Paediatrician at UCL Hospitals NHS Foundation Trust & Great Ormond Street Hospital for Children NHS Foundation Trust. Sir Terence is also a former Dean of the University of Nottingham’s Medical School, President of the Royal College of Paediatrics and Child Health, Chair of the Academy of Medical Royal Colleges, and most recently of the General Medical Council.

Professor Nick Lemoine is medical director of the National Institute for Health Research Clinical Research Network for England. Nick has recently been appointed chair of the COVID-19 urgent public health studies group for the UK. The group’s remit is to consider all clinical studies relating to COVID-19 and to fast-track those with the greatest promise. Nick also chairs the NIHR Invention for Innovation Challenge Panel. Nick is director of the Barts Cancer Institute, Queen Mary University of London, and director of research & development for Cancer at Barts Health NHS Trust, the largest NHS Trust in the country. Among other commitments, he is the chair of Trustees of the Medical Research Foundation (the MRC’s independent charity), and executive dean of the Academy of Medical Sciences, Zhengzhou University, People's Republic of China. He was elected as a Fellow of the Academy of Medical Sciences in 2006, and as a Foreign Academician of the Chinese Academy of Engineers in 2017.

Dominic Tyer, interim managing editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.