Virtual pediatric clinical trials to become routine

A UK-based company which develops computer modelling and simulation services for the pharmaceutical industry has created a pediatric simulator to allow the virtual testing of drugs for babies, infants and children. Part of the reason for developing this clinical trial tool is the adoption earlier this year by the European Medicines Agency (EMEA) of the Pediatric Investigation Plans issued by the EMEA's Pediatric Committee (PDCO; Marketletter January 14).

Under the provisions of PIPs, a six-month extension of the Supplementary Protection Certificate may be awarded in the event that child-specific testing is carried out by the owner of a patented drug. However, the director of pharmaceutical policy for one European drugmaker told the Marketletter, at an event co-hosted by the European Federation of Pharmaceutical Industries and Associations and the EMEA (Marketletter February 12, 2007), that the concern for some firms is that the pediatric regulation will make marketing application costs in the European Union rise without any proportionate benefit. It could therefore, he argued, contribute to a reduction in new product developments.

However, the Simcyp simulator is designed to help by overcoming some of the difficulties and costs of child-specific clinical studies. Steve Toon, the firm's executive director, said that "the Simcyp Pediatric Population-based ADME Simulator is a tool which allows complex clinical scenarios to be explored in the safety of a computer. Modeling 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." He added that several of the drugmakers enrolled in the Simcyp Consortium have taken up the simulator.