Programme

Tuesday 17th December - Chair: Dr Virginia Acha, Associate Vice President, Science and Regulatory Policy, MSD
09.30	Welcome and Introduction Professor Atholl Johnston
09.35	The MHRA, Past Present and Future The clinical trials market was valued at £2.3 billion in 2022, projected to reach £3.2 billion by 2028. In the summer of 2023, the Agency faced a substantial challenge: the clinical trial backlog. The introduction of the risk proportionate approach, new processes, a large workforce allowed the Agency to restore its performance. Since September 2023, the Agency has been meeting its statutory timeline, showing consistency and sustainability. The introduction of the new clinical trial operating model will consolidate the UK's position as one of the best places for conducting clinical research, benefiting patients, researchers, and industry nationally and internationally. Professor Andrea Manfrin, Deputy Director Clinical Investigations and Trials, MHRA
10.05	Questions
10.15	Progress on delivering the response to Lord O’Shaughnessy’s review Lord O’Shaughnessy published a review of commercial clinical trials in the UK in 2023. The government published a response setting out the actions it would take forward. One year later, what progress has been achieved and what is happening now? Dr Janet Messer, Executive Director, and Director of Approvals Service, HRA
10.45	Questions
10.55	Coffee Break
11.25	FDA Guidance on DCT - Key points The FDA guidance has been finalised this September. We will review the major implication of the guidance and run thorough the highlighted areas in the guidance where the FDA believe need special attention in designing a trial with DCT elements. Ending with a foundational approach to Protocol design and implementation. Dr Graham Wylie, Executive Chairman, The Medical Research Network
11.55	Questions
12.05	A toolkit for capturing a representative and equitable sample in health research Systematic excluding particular groups from research limits the generalizability of research findings and perpetuates health inequalities. The REP-EQUITY toolkit guides representative and equitable inclusion in research, describing seven steps for investigators to consider by defining (1) relevant underserved groups, (2) aims relating to equity and representativeness, (3) sample proportion of individuals with characteristics associated with being underserved by research, (4) recruitment goals, (5) strategies to manage external factors, (6) how representation in the final sample will be evaluated and (7) legacy of having used the toolkit. The toolkit could promote trust, increase diverse participation in research and improve research generalizability. Dr Ameeta Retzer, Research Fellow, Centre for Patient Reported Outcomes Research, University of Birmingham
12.35	Questions
12.45	Lunch Break
13.45	MHRA and its Role in Clinical Investigations for Clinical Devices An overview of the clinical investigations process from an MHRA perspective. Mark Grumbridge, Head of Clinical Investigations, MHRA
14.15	Questions
14.25	Update on Clinical Trial Regulations This session will provide an overview of the upcoming UK Clinical Trial Regulations which are being amended to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Dr Catherine Blewett, Senior Development Manager, HRA
14.55	Questions
15.05	Tea Break
15.35	Do No Harm by Design: The Role of In Silico trials in Safer and Sustainable Medical Innovation In silico trials (ISTs) and computational medicine are poised to transform medical device development and regulation, embodying the principle of "Do No Harm by Design". This talk explores how ISTs can address the limitations of traditional clinical trials, including high costs, lengthy timelines, and safety concerns. By simulating device performance in virtual environments, ISTs offer a pathway to accelerate innovation, reduce expenses, and enhance patient safety. We'll examine compelling examples demonstrating ISTs' ability to replicate and extend traditional trial insights, tackling challenges like off-label use, device-dependent healthcare inequities, and optimal treatment stratification. Emphasising collaboration between regulators, industry, and patients, we'll discuss how ISTs can foster safer, more sustainable medical innovation. Professor Alejandro Frangi, Director, The Christabel Pankhurst Institute
16.05	Questions
16.15	Trials@Home RADIAL – A Unique DCT Case Study Trials@Home is investigating all facets of DCTs via this EFPIA motivated and IMI funded project. T@H is a consortium of over 30 pharmaceutical, commercial and academic organisations and in addition to publishing multiple academic papers, has also designed the RADIAL study, a trial comparing conventional, hybrid and virtual methodologies. The ultimate aim is to provide recommendations to industry on how to set-up and run DCTs in the future. Paul will briefly take you through this case study and include areas such as regulatory scrutiny, technology identification, implementation & patient use, protocol design, data privacy, patient recruitment (with a focus on virtual sites), trial logistics and home visits. Specifically, Paul will discuss the lessons learned to date from running the RADIAL project and what the industry might learn from its recommendations. Paul Bodfish, DCT Consultant
16.45	Questions
16.55	Summing up and CLOSE Dr Virginia Acha and Professor Atholl Johnston