Avicenna Alliance Response to 2023 Stakeholders' Targeted Consultation on EU4Health
The Avicenna Alliance stressed the need for further support and guidance for digital evidence from in silico medicine, i.e., by ensuring and supporting international acceptance and usage of digital evidence for medical and pharmaceutical research.
To this end, an action needed would be creating "Good Simulation Practices" for computer modelling and simulation (in silico medicine) such that the acceptance of digital evidence - and thus benefits that come with it (increased patient safety, speed of development, patient access) - is cemented within the EU for research and medicines.
Good Simulation Practice in the EU would set standards for in silico trials & drug development, much in the way that clinical trials or in vitro pharmaceutical research is held to specific standards. Then, digital evidence can be better accepted (by researchers, the EMA, etc) and provide significant health - as well as resource and cost - benefits. Industry & research are already using in silico; the EU must recognise this and provide a framework for its inclusion in standard EU practice.