The project’s 1st Event took place in Rome, Italy on the 21st March 2014.The Avicenna team wishes to thank all the attendees for their important contribution to the project!
The project is named for the Persian philosopher Avicenna who first introduced the concept of the clinical trial in his “Canon of Medicine”, completed around 1025 AD. The fundamental nature of clinical trials has changed surprisingly little since Avicenna’s time. The beginning of the 21st century, however, saw the birth of in silico medicine, a completely new way to investigate living organisms and the diagnosis, treatment, and prevention of disease through modelling, simulation and visualisation of biological and medical processes using computer simulations. In silico medicine is based on the use of Virtual Physiological Human (VPH) models, which aim to integrate physiological processes across different length and time scales (multi-scale modelling) to provide improved predictive and individualised healthcare.
The provision of health care is a worldwide problem and we want to provide better healthcare for every human being. In developed countries, we are now particularly concerned with dealing with the increasing demand and challenges for the healthcare of an aging population with the associated increase in incidence of diseases such as osteoporosis and dementia. The challenge is to continue to provide improving healthcare, while keeping the cost at acceptable levels.
So far, VPH technologies have been used primarily in diagnosis, prognosis and treatment but, in principle, the same VPH models could be used to explore how a new medical product will perform, over a large population of many individuals, each with a different, age, gender, body weight, genetic mark-up, life style, etc. This is now referred to as in silico clinical trials, where VPH models are used in the development and assessment of new drugs, new medical devices and new health technologies.
Avicenna will develop a Roadmap towards the development of in silico clinical trials, where such models can be used in the development of new drugs and medical devices, reducing risks for volunteers and the need for animal experiments.
During the length of the project, we will be inviting experts from relevant stakeholder groups to participate in one or more of a carefully crafted series of discussions in key European locations, designed ultimately to lead to further support for the development and testing of the technology. A system of measuring and ascertaining alignment among groups – Alignment Optimisation (AO) will be used.
The First Event brought together around 35 of the world’s experts from across academia, industry, healthcare, and our regulatory agencies to discuss this important topic. The plan for the first event was to establish the vocabulary and confirm the terminology for the in silico clinical trials process. It was also planned to outline the issues that need to be addressed for ISCT to become a reality. A number of Alignment Optimisation cycles and and interviews were held prior the event to ascertain the current thinking on ISCT and determine were there was disagreement or misalignment. These issues were then discussed during the full day event in Rome. A list of suggested new terminology was made and opinion sought on various areas of misalignment.
The second event to discuss Conceptual Completeness is planned for the beginning of June and 3 further events over the following 18 months will tackle the overall concept, the technical and regulatory systems required, and finally the standards to which in silico clinical trials will operate. A crucial part of our activity is reaching agreement on how we might all continue to work together, after this 18-month planning period, to complete the process and actually create working computer – ‘in silico’ – simulations, to our agreed standards.
Our email address is: firstname.lastname@example.org
Our website is: www.avicenna-isct.org