The use of 'virtual' studies in children could soon become routine in following the introduction of EU regulations requiring paediatric investigational studies for new medicines in development
The legislation was introduced to address the issue that over 50% of medicines currently used in children have not been officially tested in this age group.
Simcyp, which provides modelling and simulation services to the pharmaceutical industry, has developed a paediatric simulator for evaluating medicines in virtual populations of babies, infants and children.
Traditionally, many medicines administered to children have been used 'off-label' with doses determined by scaling back from doses used in adults.
This results in increased risks of adverse effects due to inappropriate dosing.
In hospital inpatients the overall incidence of adverse drug reactions in children is 9.5%, with an associated additional cost of treatment averaging ?8000 per individual.
Professor Amin Rostami, director of research and development at Simcyp, commented: "Many changes occur during development which affect the way that the body handles medicines.
"In particular, children under two years old are the most physiologically different to adults, so it can be too simplistic to scale back from adult values when determining appropriate doses for children.
"Simcyp's simulations incorporate demographic and developmental information providing a more 'real world' prediction of drug behaviour across the paediatric age range".
The aim of the regulation is to protect the health of children by increasing high quality, ethical paediatric research and improving the availability of authorised medicines for children.
This should be achieved without unnecessary studies in children and without delaying authorisation for adults.
The regulation came in to force in January 2007 with a key provision that paediatric data must be provided in all applications for marketing authorisation of new medicinal products from 26 July 2008.
An extra six months patent protection is being offered as an incentive for companies to develop medicines for use in children.
Steve Toon, executive director of Simcyp commented: "The Simcyp paediatric population-based Adme simulator is a tool which allows complex clinical scenarios to be explored in the safety of a computer.
"Modelling and simulation can negate the need for some 'real-life' studies, circumventing many of the ethical and practical issues that arise when pharmaceutical companies conduct clinical trials in young subjects.
"Many of the major pharmaceutical companies within the Simcyp Consortium have already taken up the simulator with a view to designing the most efficient clinical studies in children and ultimately reducing the number of necessary clinical studies required by regulatory authorities."
