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. 

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

Virtual You vs Cancer: How Digital Twins Are Revolutionizing Treatment

What if your doctor could test hundreds of cancer treatments on a virtual version of your tumour before giving you a single dose of medication? In this episode, we dive into the fascinating concept of digital twins, particularly their application in oncology.
Discover how digital twins, virtual replicas of tumours, are being used to simulate treatment scenarios and predict outcomes, offering unprecedented precision in cancer care. Learn about the intricate process of creating these digital twins, from capturing medical imaging data to developing complex mathematical models. With insights tailored to the individual, digital twins represent the future of personalized medicine, enabling clinicians to experiment with different therapies without any risk to real patients.
Explore the real-world impact of this technology, as digital twins assist doctors in treatment planning and help predict patient responses to various drugs. As we stand on the cusp of a revolution in cancer care, join us in unravelling the potential of digital twins to transform how we diagnose, treat, and manage cancer. Tune in for this deep dive into the groundbreaking world of InSilico trials and their real impact on patient care.Wu C, Lorenzo G, Hormuth DA 2nd, Lima EABF, Slavkova KP, DiCarlo JC, Virostko J, Phillips CM, Patt D, Chung C, Yankeelov TE. Integrating mechanism-based modeling with biomedical imaging to build practical digital twins for clinical oncology. Biophys Rev. 2022 Jun;3(2):021304.

Digital Footprints to Medical Breakthroughs: The Real-World Data Revolution

What if the future of healthcare innovation lies not in controlled trials, but in the digital footprints we leave every day? Real-world data from health records, wearables, and patient experiences revolutionises medical research. This episode explores the profound impact of real world data (RWD) in healthcare.
Discover how everyday data sources like Fitbits, electronic health records (EHRs), and insurance claims are reshaping the medical landscape. Learn about the nuances of real world data, from its messy nature to its invaluable insights for patient care.
Dive into the complexities of data standardization, the use of machine learning, and the challenges of privacy and bias. Explore how RWD is paving the way for personalized medicine and disease prevention, offering hope for rare disease research through global data pooling.
Join the conversation about the future of healthcare, privacy concerns, and the exciting potential of sharing patient-generated data. Tune in now and be part of the revolution where algorithms, data, and human insight converge to shape a healthier tomorrow.
 
Liu F, Panagiotakos D. Real-world data: a brief review of the methods, applications, challenges and opportunities. BMC Med Res Methodol. 2022 Nov 5;22(1):287. doi: 10.1186/s12874-022-01768-6. Erratum in: BMC Med Res Methodol. 2023 May 2;23(1):109. doi: 10.1186/s12874-023-01937-1.
 

The Science Behind Making Virtual Trials Trustworthy: Ten Rules

Would you trust a computer to help decide your medical treatment? Imagine doctors using virtual experiments to test treatments before giving them to real patients - sounds like sci-fi, right? But it's happening now! Just like pilots train in flight simulators before flying real planes, scientists are using powerful computer models to improve healthcare.
But here's the million-pound question: How do we know these digital predictions are reliable?
In this episode, we'll reveal the 10 golden rules scientists follow to ensure their virtual experiments are trustworthy. From making sure they're using the right data to having independent experts check their work (like having a second opinion from another doctor!), these rules are changing the game in modern medicine.
 
Erdemir A, Mulugeta L, Ku JP, Drach A, Horner M, Morrison TM, Peng GCY, Vadigepalli R, Lytton WW, Myers JG Jr. Credible practice of modeling and simulation in healthcare: ten rules from a multidisciplinary perspective. J Transl Med. 2020 Sep 29;18(1):369. doi: 10.1186/s12967-020-02540-4. 
Manchel A, Erdemir A, Mulugeta L, Ku JP, Rego BV, Horner M, Lytton WW, Myers JG Jr, Vadigepalli R. A rubric for assessing conformance to the Ten Rules for credible practice of modeling and simulation in healthcare. medRxiv [Preprint]. 2024 Nov 2. doi: 10.1101/2024.10.31.24316520.
 

STANDING Together: Equitable AI and In Silico Technologies in Healthcare

What if In Silico Technologies in healthcare could truly serve everyone? The STANDING Together recommendations are revolutionising how we think about health data diversity and inclusion. From bustling cities to remote villages, discover how this groundbreaking initiative is reshaping healthcare technologies development through the voices of patients, practitioners, and policymakers. Join us as we explore the journey towards equitable healthcare technology that leaves no one behind
We'll explore the importance of data diversity and patient involvement in shaping the future of medical technology—be it AI diagnostic systems or in silico technologies predicting drug interactions. Understand how these recommendations propose a shift towards a more responsible and inclusive approach, requiring the commitment of researchers, developers, policymakers, and patients themselves.
This episode highlights patient advocacy, urging everyone to become proactive in their healthcare journey and data literacy. As AI becomes increasingly integrated into our lives, ensuring fairness and equity becomes paramount—a responsibility we all share.www.datadiversity.org
Alderman JE, Palmer J, Laws E, McCradden MD, Ordish J, Ghassemi M, Pfohl SR, Rostamzadeh N, Cole-Lewis H, Glocker B, Calvert M, Pollard TJ, Gill J, Gath J, Adebajo A, Beng J, Leung CH, Kuku S, Farmer LA, Matin RN, Mateen BA, McKay F, Heller K, Karthikesalingam A, Treanor D, Mackintosh M, Oakden-Rayner L, Pearson R, Manrai AK, Myles P, Kumuthini J, Kapacee Z, Sebire NJ, Nazer LH, Seah J, Akbari A, Berman L, Gichoya JW, Righetto L, Samuel D, Wasswa W, Charalambides M, Arora A, Pujari S, Summers C, Sapey E, Wilkinson S, Thakker V, Denniston A, Liu X. Tackling algorithmic bias and promoting transparency in health datasets: the STANDING Together consensus recommendations. Lancet Digit Health. 2025 Jan;7(1):e64-e88. doi: 10.1016/S2589-7500(24)00224-3.
 

Can Computer Simulations Make Medical Products Safer?

Ever wondered how we can make shoulder replacements safer without endless clinical trials? Step into the future of medical innovation where virtual patients help test new drugs and devices. Discover how computer simulations could make medicine safer, faster, and more ethical. Learn why experts believe digital trials might be the game-changer healthcare has been waiting for.
Viceconti M, Emili L, Afshari P, Courcelles E, Curreli C, Famaey N, Geris L, Horner M, Jori MC, Kulesza A, Loewe A, Neidlin M, Reiterer M, Rousseau CF, Russo G, Sonntag SJ, Voisin EM, Pappalardo F. Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE J Biomed Health Inform. 2021 Oct;25(10):3977-3982. doi: 10.1109/JBHI.2021.3090469.
 
 
 

Cutting Costs, Boosting Results: The Tech Revolution in Clinical Trials

Why are clinical trials becoming so expensive? Dive into the financial maze of skyrocketing costs, from patient recruitment challenges to decentralization hurdles. Discover how patient-centric strategies and digital tools are reshaping the landscape, cutting costs, and boosting efficiency. Join us as we uncover the hidden drivers behind these rising expenses and explore innovative solutions to optimize clinical trials. Don't miss it!DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016 May;47:20-33.
Moore TJ, Heyward J, Anderson G, Alexander GC. Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study. BMJ Open. 2020 Jun 11;10(6):e038863. 
MDGroup (2020) The True Cost Of Patient Drop-outs In Clinical Trials. https://mdgroup.com/blog/the-true-cost-of-patient-drop-outs-in-clinical-trials
 
 
 
 
 
 

Breaking New Ground: The Virtual Trial Transforming Knee Surgery

Can 3D-printed, personalized knee surgery implants revolutionize arthritis treatment? Virtual clinical trials show promising results for a custom device that could make corrective knee surgery safer and more accessible. Discover how computer simulations are paving the way for the future of personalized orthopaedics.MacLeod AR, Peckham N, Serrancolí G, Rombach I, Hourigan P, Mandalia VI, Toms AD, Fregly BJ, Gill HS. Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case-control in silico clinical trial. Commun Med (Lond). 2021 Jun 30;1:6. doi: 10.1038/s43856-021-00001-7.
 
 
 
 
 
 

Standards as Innovation Catalysts: The PAGIT Framework

How can we unlock innovation while ensuring responsible governance? Dive into the evolution of the PAGIT framework, where standards meet strategic oversight. From disruptive technologies to incremental advances, discover how this groundbreaking approach is reshaping the UK's innovation landscape. Join us to explore how smart regulation and standards are building tomorrow's technological future.
Tait J (2024) The PAGIT framework: Its role in the governance of UK technologies to drive greater innovation, BSI, https://www.bsigroup.com/en-GB/insights-and-media/insights/whitepapers/update-to-pagit-framework-for-innovation.

In Silico vs. Real Life: Can Computer Models Outperform Spine Surgery Tests?

Can computers predict if medical devices are safe? Discover how virtual testing revolutionises surgical implant design, potentially saving millions in development costs and speeding up innovation. Learn how digital twins are helping bring safer bone screws to the operating room, faster than ever before.
 
Nagaraja S, Loughran G, Baumann AP, Kartikeya K, Horner M. Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods. 2024 May;225:74-88. doi: 10.1016/j.ymeth.2024.03.003.

Heartware: Programming the Perfect Heartbeat

This week we ask: Can computers help us revolutionise heart failure treatment? Join us as we explore how computational modelling is transforming cardiac pacing therapy. Discover how virtual trials are accelerating research, optimising treatment strategies, and improving patient outcomes—all before a single device is implanted. Learn how this cutting-edge approach is helping clinicians identify the right treatment for the right patient, potentially changing the future of cardiac care. A fascinating intersection of computer science and cardiology you won't want to miss.
 
Strocchi M, Wijesuriya N, Mehta V, de Vere F, Rinaldi CA, Niederer SA. Computational Modelling Enabling In Silico Trials for Cardiac Physiologic Pacing. J Cardiovasc Transl Res. 2024 Jun;17(3):685-694. doi: 10.1007/s12265-023-10453-y.
 

Digital Twins Revolutionizing Shoulder Implant Design

Ever wondered how we can make shoulder replacements safer without endless clinical trials? In today's episode, we dive into groundbreaking research that's revolutionising orthopaedic device testing through virtual simulations. We'll explore how researchers have developed a sophisticated computational model that predicts when shoulder implants might loosen – a critical concern in shoulder replacement surgery.
What makes this study fascinating is its dual-validation approach, which combines laboratory tests with real-world clinical data. We'll unpack how the team validated their virtual model using foam block experiments and actual patient outcomes, creating a bridge between controlled testing and clinical reality.
But here's the real kicker – this research could transform how we test medical devices, potentially reducing the need for extensive human trials. We'll discuss how this model handles different implant designs and surgical variations and what it means for the future of orthopaedic device development.
Join us as we explore the intersection of virtual testing and real-world medicine!
 
Maquer G, Mueri C, Henderson A, Bischoff J, Favre P. Developing and Validating a Model of Humeral Stem Primary Stability, Intended for In Silico Clinical Trials. Ann Biomed Eng. 2024 May;52(5):1280-1296. doi: 10.1007/s10439-024-03452-w
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Enhancing UK Medicine Regulation

Can the UK reclaim its crown as a clinical trials powerhouse? As Baroness Merron champions modernised regulations through Parliament, ABPI's candid assessment of MHRA reveals both progress and untapped potential. Join us in this bonus episode to explore how strategic reforms could transform the UK into a global life sciences leader.Association of British Pharmaceutical Society (2024). Enhancing the role of UK medicine regulation. https://www.abpi.org.uk/publications/enhancing-the-role-of-uk-medicine-regulation
Baroness Merron (2024) Clinical Trials Regulations. Statement on UK Parliament 12-12-24. https://questions-statements.parliament.uk/written-statements/detail/2024-12-12/hlws306 
 
 
 
 
 
 

How Regulatory-Ready is Model-Informed Drug Development?

Can we truly trust mathematical models to shape the future of medicine? In this episode, we explore the fascinating world of Model-Informed Drug Development (MIDD)—a game-changing approach that blends cutting-edge simulations with real-world data to revolutionise how drugs are developed and approved.
With the new ICH M15 Guideline, the global pharmaceutical landscape is moving towards a harmonised framework that ensures credibility, consistency, and trust in MIDD evidence. But how do these models hold up under scrutiny? And what does this mean for patient safety, regulatory decision-making, and the future of innovation in healthcare?
Join us for an engaging discussion on the science, risks, and rewards of MIDD, and discover how this transformative approach is reshaping the way medicines are brought to life.
 
Marshall S, Ahamadi M, Chien J, Iwata D, Farkas P, Filipe A, Frey N, Greene E, Kawai N, Li J, Lippert J, Musuamba Tshinanu F, Manolis E, Peterson MC, Sarem S, Shebley M, Tegenge M, Tsai CH, Tu CL, Otsubo Y, Wei J, Zhang L, Zhu H, Karlsson KE. Model-Informed Drug Development: Steps Toward Harmonized Guidance. Clin Pharmacol Ther. 2023 Nov;114(5):954-959. doi: 10.1002/cpt.3006.