Project Proposal

Dear Crowdhelix members,

We are pleased to invite you to join the new In Silico Trials Helix to tackle one of the most pressing challenges in healthcare. With regulatory success rates of new medical products declining and clinical trials cost rising, innovation of medical products is stagnating despite increasing demand and technological innovations. Clinical trials in Europe, the US and the UK are moving abroad with lower costs. However, patient profiles, regulations and quality assurance may differ from those relevant to ensuring patient benefit in each geography. One reason for failure is that traditional trials aim to establish efficacy/safety for most subjects, rather than individual subjects, so efficacy is determined by a statistic of central tendency for the trial. Traditional trials do not adapt treatment to covariates of subjects, so so-called Precision Medicine becomes elusive. Many reports have pointed to this broken/slow innovation system and its impact on societal costs and suboptimal healthcare. However, radical changes to this innovation process are still to be developed. Dealing with the extraordinary multi-scale complexity and variability intrinsic to human biological systems and health data requires radically new approaches compared to methods for manufactured systems. Computational Medicine (aka in silico medicine) is an emerging discipline devoted to developing quantitative approaches for understanding the mechanisms, diagnosis, and treatment of human disease through the systematic application of mathematics, engineering, and computational science.

The In Silico Trials Helix aims to amplify visibility and international collaboration among all in silico stakeholders. To do so, this Helix, led by the University of Leeds and KU Leuven, works with broader global and national initiatives like the Virtual Physiological Human Institute, InSilicoUK and the Avicenna Alliance. We are convinced that in silico medicine and in silico trials, we can help address these problems and transform healthcare for the benefit of patients, healthcare systems, and the associated sector. Recent developments in patient-specific computational simulations have enabled in silico trials to predict the safety and efficacy of novel drugs, medical devices, or other treatments as part of the research and development life cycle. Some benefits of in silico trials include: (i) enabling more evidence to be obtained before the bench or animal studies are started; (ii) extending the trial cohort to rare, extreme or difficult-to-recruit patient phenotypes; (iii) directly comparing two alternative treatments in the same virtual population (reducing the observed effect variance); (iv) evaluating devices under practically challenging physiological conditions that could represent extreme but plausible applications (off-label use); and (v) reducing the number of animals and humans required in trials, and the refinement of long-term studies to minimise suffering. Studies are beginning to demonstrate that human in silico drug trials demonstrate higher accuracy than animal models, accuracy higher than animal models.

Worldwide industry representing medical devices, pharma, and simulation, as well as professional societies, academia, and regulators, are heavily engaged in driving innovations in computational modelling and simulation into regulatory science, promoting methods and processes delivering best in class in silico evidence, and engaging with patients to listen and communicate with the broader community on concerns and potential benefits of this approach. The US has actively developed partnerships between the FDA and Industry, particularly via the Medical Device Innovation Consortium. Internationally, both the Virtual Physiological Human Institute and the Avicenna Alliance take on this role as connector between different stakeholders, preparing the path from the computer screen to the patient.

For further information about the In Silico Trials Helix, visit https://www.crowdhelix.com/hel... and click “Follow” to become an active member. You will then be notified of new opportunities and activities powered by this Helix.

We are looking forward to meeting and working with you in the In Silico Trials Helix.

Best regards,
Liesbet Geris and Alex Frangi