IN SILICO CLINICAL TRIALS: DREAM OR CERTAINTY?
The huge cost of developing new medical products has many consequences. Countries with universal healthcare struggle to afford the best new products, and in countries with private healthcare only the wealthy can afford the best treatments. Many conditions are ignored by the biomedical industry because they cannot return the significant investment needed for clinical trials – because the groups of people affected by the conditions are too small (e.g. Sanfilippo Syndrome) or too poor (e.g. Chagas disease). The Avicenna Consortium believes computer simulation is one solution that will contribute to revolutionising the clinical trials process. In all other industrial sectors, computer simulation plays an essential role in the design and assessment of new products. Given recent advances in medical imaging and other analytical technologies, the Avicenna Consortium asked if we have collected enough knowledge to start using computer simulation in the development of medical products. Could we use the computer simulation of individual patients’ bodies in the development or regulatory evaluation of a
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medicinal product, medical device or medical intervention? If we could, what would be the barriers to its widespread adoption? In its conclusions, the Avicenna Roadmap states that, in the opinion of the Consortium and the contributors to the Avicenna Research and Technological Roadmap, the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device or medical intervention (generally referred to as “in silico clinical trials”) is one of the most important strategic priorities in biomedical and technological research, if we want to make the development and assessment of new biomedical products simpler, cheaper, faster and safer, whilst at the same time minimising those activities such as animal or human experimentation that pose ethical concerns. It recommends that all public and private research funding agencies across the world do the following. a) Acknowledge the significant socioeconomic relevance that research and technological development, assessment and
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adoption of in silico clinical trials technologies pose. The mounting needs of universal healthcare provision in developed countries exceed our ability to innovate quickly and efficiently, and in silico approaches are the best possible route to address those needs. b)Progressively increase the expenditure in this area in the next 5 years, so that by 2020 at least 1% of the total public and private expenditure in biomedical research and development worldwide (estimated as US $268 billion in 2012) is dedicated to the development and adoption of in silico clinical trials technologies used to translate biomedical research discoveries into new products and services more quickly, safely and efficiently. This should be initiated with a dedicated programme in the 2016/17 European Commission Work Programme of the European Union Horizon 2020 programme, with a budget of at least €50 million per year.
european INDUSTRIAL PHARMACY September 2015
• Issue 26