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European Pharmaceutical Contractor
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The Growth of Paediatric Clinical Trials
Parallel initiatives introduced in the US in the late 1990s have led to unprecedented growth in the field of paediatric clinical trials and the globalisation of activities in this area (see Figure 1). In brief, the Paediatric Rule of 1998 (1) mandates sponsors to collect data from children for labelling purposes. The paediatric provisions of the FDA's Modernisation Act of 1997 (2), recently incorporated into the US Best Pharmaceuticals for Children Act 2002 (3), provides sponsors with an incentive to conduct the trials - an additional six months of patent life for the drug under study. This carrot and stick approach has had a twofold effect. Firstly, the sheer number of trials has increased enormously. Recent FDA data shows that since the incentives came into effect, the FDA has requested nearly 600 trials involving around 35,000 children.
Secondly, paediatric trials are now being seen at a much earlier stage of the drug development process. Indeed, the recent ICH document E-11 (4) recommends the early and urgent initiation of trials for compounds that will treat serious childhood diseases, or those that may be thought of as a considerable therapeutic advance. Traditionally, such trials - if conducted at all - were not usually seen until the drug's adult programme had reached Phase IV, or at least until a significant amount of adult data had been gathered.
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