What are general and long term goals of the project?
The term “Clinical trial” indicates the studies that are routinely conducted to establish the safety and efficacy of new medical interventions. The term In Silico Clinical Trials (ISCT) refers to “The use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device or medical intervention”. The need for long and complex experiments in vitro, on animals, and then on patients during clinical trials pushes development costs to unsustainable levels, stifling innovation, and driving the cost of healthcare provision to unprecedented levels. Avicenna was tasked with writing a Roadmap to define the strategy for developing ISCT. The Roadmap provides an overview of how biomedical products are developed today, where In Silico Clinical Trials technologies are already used, and where else they could be used. From the identification of the barriers that prevent wider adoption, we derived a detailed list of research and technological challenges that require pre-competitive funding to be overcome.
Please state a few more specific objectives of the project.
In the 24 months of its duration, the Avicenna support action has formed an international Community of Practice involving multiple industrial sectors (pharma, medical devices, software, hardware, etc.) and categories of stakeholders (providers, producers, academia, regulators, etc).
The final Avicenna roadmap, that will be published in the next few days will be, with its 11 chapters and over 65,000 words the most exhaustive survey on the world of in silico clinical trials ever published. In addition to being a complete reference to this complex and fragmented domain, the roadmap provides an in depth analysis of the research and technological development challenges that need to be overcome in order to have a wider and more effective adoption of in silico technologies in the development of biomedical products. The final roadmap can be downloaded here.
The motivation for creating an alliance between academia and industry was largely driven by a desire to have a mechanism offering continuity beyond the end of the Avicenna Project creating an entity capable of working on the objectives and recommendations listed in the Roadmap and building on the momentum generated during the project. In this way, concrete evidence could be provided not only of the relevance of these approaches to healthcare, supported through clear case studies and examples, but also their commercial relevance through the direct engagement of key industries in the collaborations that would emerge. This was also seen as a necessary first step towards building a strong proposal for the creation of a Private Public Partnership as a formal entity. The combination in the Alliance of key academic leaders and major industries, spanning medicines, devices and software amongst others, will offer a central resource of experts to work with regulators, commissioners and politicians as necessary to establish computer modelling and simulation as a core technology in 21st Century medical and surgical practice.
Describe the methodology, approach and technologies used.
The Avicenna Action has engaged 525 experts from 35 countries, including 22 of the 28 members of the European Union, in an 18-month consensus process which sought to engage the key players for each of the participating sectors from industry, academia, regulators etc., to define the respective industrial challenges and opportunities for ISCT, in order to produce a research and technological development Roadmap. The consensus process involved 5 physical meetings in Europe and the use of a process called Alignment Optimisation (AO). AO acquires information and opinions through a three-stage process, starting with telephone interviews, followed by an on-line opinion survey and finally analysis and alignment of the opinions generated. This process follows the well-established expert systems of Alignment Optimisation as practiced by SchellingPoint LLC.
How is the project progressing, any results you wish to highlight?
The Avicenna project came to a successful conclusion at the final review in Brussels on 30 September 2015 with the publication of the research and technological development Roadmap outlining a strategy for in silico Clinical Trials (ISCT). The Roadmap describes the route by which in silico techniques of computer simulation will be introduced into clinical trials. The Roadmap recommends that the European Commission, and all other international and national research funding agencies support in silico clinical trial approaches, which could have huge socio-economic impact in the future. It also recommends industrial and academic stakeholders explore the formation of a pre-competitive alliance to coordinate and implement public and private funded research on this topic. Last, but not least, it recommends that the regulatory bodies across the world avoid becoming the bottleneck for innovation and, in collaboration with academic and industrial experts, develop the framework of standards, protocols and shared resources required to evaluate the safety and the efficacy of biomedical products using In Silico Clinical Trials technologies.
Funding source and funding duration:
“Avicenna – A Strategy for in silico Clinical Trials” was a Coordination and Support Action funded by the European Commission as part of the Seventh Framework Program for Research and Technological Development (FP7), under the Information Communication Technologies Programme (Contract Number 611819). 24 months (2 years)