On Monday 22 May 2023, the SIMCor consortium held the first of its focus groups on in-silico medicine. The event was hosted by the University College London (UCL) at the Zayed Centre for Research of its affiliated Great Ormond Street Hospital (GOSH).

The SIMCor focus groups have been conceived as multi-stakeholder discussion forums where to explore the clinical, scientific, legal and ethical aspects of in-silico trials, and more specifically the use of computer-based simulation for the testing, validation and regulatory approval of medical devices in cardiology, as well as for clinical decision support, at the presence of researchers, healthcare professionals and patients. 

The SIMCor focus groups on in-silico medicine, to be held in London, Berlin and Vienna between May and September 2023, have been organised as a joint effort of an interdisciplinary team including in-silico medicine researchers, sociologists, researchers in economics and science communication experts from our partners Charité – Universitätsmedizin Berlin (CHA), University College London (UCL), the Virtual Physiological Human (VPH) Institute, the Institute for Advanced Studies Vienna (IHS) and Lynkeus (LYN), leveraging the partners’ experience on patient focus groups, also in the context of sister in-silico medicine projects (In Silico World).

These focus groups, to be further sustained by surveys and one-to-one interviews, have been designed not only as a mean of addressing cardiologic patients’ and citizens’ questions, issues and concerns, but also to gain fundamental insigths for the healthcare and socioeconomic impact assessment of in-silico testing technologies and, on a broader scale, towards the development of more ethical and user-driven virtual twin technologies.

This first focus group included a small group of patients that underwent TAVI procedure and caregivers, a clinician and some in-silico researchers from the consortium.

The programme (10:00 – 12:00 am) of the event encompassed:

• 10:00 am: Welcome and greetings
• 10:15 am: SIMCor focus group methodology and scope + Q&A: focus group methodology, structure and agenda, plus a brief introduction of participants
• 10:25 am: In-silico medicine and SIMCor as a use-case application of in-silico cardiology – an introduction + Q&A: introduction to the medical device approval process, in-silico medhods for medical device testign and potential implications
• 10:45 am: Open discussion of in-silico cardiology: first impressions and considerations on the topics above.
• 11:00 am: Break
• 11:10 am: Targeted discussion: use-case scenarios: discussion of specific scenarios of testing and regulatory approval of medical devices on the cardiovascular domain,
• 12:00 noon: Conclusion of the event and lunch.

What emerged from the discussion with patients is quite promising on the prospect of making in-silico medicine a reality for medical device testing in the future. Firstly, patients expressed highly favourable opinions on the potential use of in-silico testing methodologies for enhanced safety of new devices, as well as maximise treatment success and minimise risks, e.g., for surgical procedures, and some of them declared that they would be reassured to know that such devices, or their surgery planning, had been additionally validated through the use of computer-based methods, providing that such methods remain an addition, and not a replacement, of traditional testing methods, i.e., animal testing and clinical trials. More in general, they have shown a high curiosity towards such methods and declared to be willing to know more and keep informed on the developments to come in the field.

Secondly, patients showed a very favourable attitude towards the sharing of sensitive healthcare data for research purposes, both with public and private subjects, as they believe such use is beneficial for them and the wellbeing of others, and they have trust in the public healthcare system and its capacity to safeguard their privacy and ensure that their data is used for good.

A more detailed report of the results of the focus groups, including the ones to be conducted in Berlin and Vienna, together with results of previous focus groups conducted by the VPH Institute in the context of the In Silico World project, will be included in a dedicated peer-reviewed publication to be realised by the end of the project.