In Silico Trials, Real Impacts!

Revolutionising Healthcare: The Power of Synthetic Data

Is the healthcare sector prepared to harness synthetic data's transformative potential whilst navigating its hidden pitfalls? This thought-provoking episode delves into the murky waters of synthetic data governance in medical research, examining how generative AI is reshaping our approach to patient information. As algorithms increasingly create convincing facsimiles of real clinical data, we explore the tantalising benefits—enhanced privacy protection, expanded research capabilities, and accelerated innovation cycles—alongside the concerning governance vacuum that threatens to undermine these advances. Our discussion unpacks why the absence of standardised creation and evaluation frameworks is stalling widespread adoption, despite synthetic data's promise. We make the case for urgent development of robust data standards, ethical guidelines and cross-disciplinary collaboration to ensure this powerful tool serves healthcare's highest goals. Join us as we navigate the complex terrain where technological innovation meets patient protection, and discover why establishing clear governance frameworks today is essential for tomorrow's medical breakthroughs.
 
Boraschi D, van der Schaar M, Costa A, Milne R. Governing synthetic data in medical research: the time is now. Lancet Digit Health. 2025 Feb 20:S2589-7500(25)00011-1. 

How Can We Trust Computational Models in Healthcare? A Framework for In Silico Clinical Trials

Are you curious about how computer simulations are changing the way we evaluate medical devices? In this episode, we delve into the fascinating world of in silico clinical trials (ISCTs), a cutting-edge approach that uses computational models to assess the safety and effectiveness of medical interventions. We explore a recent paper that highlights the unique challenges of ensuring the credibility of ISCT results. The authors present a comprehensive workflow for assessing this credibility, drawing on various methodologies and frameworks, including those from the FDA. By reviewing a range of ISCT studies, we discuss innovative patient model generation techniques, the integration of clinical outcomes, and how these virtual trials can complement traditional clinical studies. Join us as we unpack the potential of ISCTs to revolutionize medical device evaluation, making it more cost-effective, time-efficient, and ethically sound.
Source: Bodner J, Kaul V. A framework for in silico clinical trials for medical devices using concepts from model verification, validation, and uncertainty quantification. J Verif Valid Uncertain Quantif. 2022;7(2):021001. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Probability & Patients: The Stochastic Science Behind In Silico Trial Breakthroughs

𝗪𝗵𝗮𝘁 𝗶𝗳 𝘁𝗵𝗲 𝗻𝗲𝘅𝘁 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗯𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗶𝘀 𝗮𝗹𝗿𝗲𝗮𝗱𝘆 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝘂𝘁𝗲𝗿? This episode explores the fascinating world of virtual patient models and stochastic engineering, unveiling how digital simulations are revolutionising healthcare clinical trials. Discover how simulated trials using sophisticated virtual patient models—complete with variations in age, body size, and disease progression—are introducing groundbreaking innovations in patient care.
We delve into stochastic engineering models that cleverly integrate uncertainty into device design, offering more precise and realistic predictions of clinical outcomes. Learn about the power prior method—a dynamic approach to combining digital and real-world evidence in clinical trials, enhancing efficiency and accelerating device delivery to patients whilst maintaining rigorous safety and accuracy standards.
Join us for an illuminating discussion at the cutting edge of healthcare innovation, where virtual modelling meets real-world patient impact.
 
Haddad T, Himes A, Thompson L, Irony T, Nair R; MDIC Computer Modeling and Simulation Working Group Participants. Incorporation of stochastic engineering models as prior information in Bayesian medical device trials. J Biopharm Stat. 2017;27(6):1089-1103. 

How can we properly evaluate the true economic impact of AI in healthcare?

How are the CHEERS-AI guidelines transforming economic evaluations of healthcare AI? In our latest podcast episode, we delve into how the Consolidated Health Economic Evaluation Reporting Standards for AI (CHEERS-AI) are revolutionizing the economic assessment landscape for artificial intelligence in healthcare. Discover why transparency and consistency are crucial, and how this comprehensive framework helps determine the true financial value of AI innovations in the medical field.
This episode navigates the intricate challenges of healthcare AI integration, including uncovering hidden costs and addressing the "black box" problem—where understanding AI's decision-making processes remains difficult yet essential for proper evaluation and implementation.
Join our conversation as we explore the broader ethical considerations and societal impacts of healthcare AI, emphasizing the importance of responsible innovation. Whether you're a health economist, researcher, or simply interested in AI's transformative potential in healthcare, this episode offers valuable perspectives on balancing innovation with responsibility to ensure AI advancements benefit both patients and healthcare systems alike.
Elvidge J, Hawksworth C, Avşar TS, Zemplenyi A, Chalkidou A, Petrou S, Petykó Z, Srivastava D, Chandra G, Delaye J, Denniston A, Gomes M, Knies S, Nousios P, Siirtola P, Wang J, Dawoud D; CHEERS-AI Steering Group. Consolidated Health Economic Evaluation Reporting Standards for Interventions That Use Artificial Intelligence (CHEERS-AI). Value Health. 2024 Sep;27(9):1196-1205. 

Revolutionising Healthcare: Inside the UK's MHRA Data Strategy

Will the MHRA's New Data Strategy Transform Healthcare Through Computational Innovation? In this episode, we explore the MHRA's groundbreaking data strategy for 2024-2027, a visionary plan heralding a fourth industrial revolution in healthcare. From supporting data-driven innovation to harnessing AI and real-world evidence, we dive deep into the strategic themes aimed at revolutionizing medical product development and regulation.
Learn how AI is set to change the game, enabling quicker development of treatments tailored to individual needs and monitoring safety like never before. We also address the challenges of data fragmentation, quality issues, and privacy concerns, while highlighting ambitious initiatives like the Centers of Excellence in Regulatory Science and Innovation.
Tune in to uncover how this strategy could position the UK as a leader in data-driven healthcare, inspiring global shifts towards personalized and equitable treatment for all.
Source: MHRA (2024) MHRA Data Strategy 2024 - 2024. www.gov.uk/government/publications/mhra-data-strategy-2024-2027

Unleashing the Potential of Health Data: Insights from the Sudlow Review

What is the roadmap to transform how we use health data in the UK? This episode discusses the Sudlow Review and highlights the immense potential of linking health data, tackling accessibility challenges, and the importance of public trust. We discuss its five critical recommendations to make health data a national infrastructure, streamlining access, and ensuring ethical governance across the UK.
Whether you're a researcher, policy maker, or simply curious about the future of medical innovation, tune in to discover how harnessing health data can revolutionize patient care and healthcare research.
Source: Sudlow C (2024) Uniting Health Data in the UK Review. Health Data Research UK. https://www.hdruk.ac.uk/helping-with-health-data/the-sudlow-review

Regulatory Frontiers: UK's Centres of Excellence in Regulatory Science and Innovation

How is the UK positioning itself at the forefront of regulatory science innovation through strategic investments in centres of excellence? This episode explores the UK Government-funded Centres of Excellence in Regulatory Science and Innovation (CERSI) Initiative and its pivotal role in shaping the future regulatory landscape for AI and in silico technologies in healthcare. We examine two of the seven CERSIs funded by UK Government. Brunel University's critical work on building trust frameworks and ethical governance for AI applications, alongside the University of Manchester's groundbreaking advances in in silico clinical trials that promise to revolutionise drug development timelines and efficiency.
This podcast delves into the regulatory science challenges and opportunities presented by these emerging technologies, offering insights into how the UK CERSI strategy is creating new pathways for innovation while ensuring patient safety. From establishing robust validation methods for in silico trials to developing adaptive regulatory frameworks for AI, discover how these centres of excellence are addressing the complex intersection of technology, healthcare, and regulation. Join us for an essential conversation about the transformative potential of these initiatives and their implications for researchers, regulators, and healthcare systems worldwide.Source: Developing regulatory science to advance healthcare (2025) www.ukri.org/news/developing-regulatory-science-to-advance-healthcare

Can NHS Secure Data Environments Unlock the Future of UK Life Sciences?

Could NHS Data Environments Revolutionise UK Life Sciences Innovation? This episode focuses on the incredible potential of NHS data in revolutionising medical product development and regulation. The Association of the British Pharmaceutical Industry (ABPI) report, published in February 2025, investigates how to improve the regional Secure Data Environment (SDE) network to better serve the life sciences industry's research needs. The report outlines findings from a consultation with ABPI, ABHI, and BIA members regarding their use of NHS health data. It highlights key industry requirements for the SDE network, including the need for federated data access, streamlined governance, and commercially competitive timeframes. The report also reveals concerns about insufficient industry involvement in the network's design and implementation. Ultimately, it provides recommendations to NHS England and other relevant bodies to align the SDE network's development with the demands of life sciences research, aiming to enhance the UK's attractiveness for R&D investment.
 
Source: Association of British Pharmaceutical Industries (2025)  The value of industry clinical trials to the UK. www.abpi.org.uk/publications/the-value-of-industry-clinical-trials-to-the-uk-extended-report