Paediatric drugs clinical trials

Expanded controlled and uncontrolled clinical trials intended to gather additional evidence of effectiveness for specific indications and to better understand safety and drug-related adverse effects. Phase III trials are usually large multicenter trials which collect substantial safety experience and may also include specialized studies needed for labelling (e.g. paediatric or elderly, comparative agents). Thousands of patients may be included in the Phase III trials. 

More and more clinical trials in children are taking place and are improving the availability of ready-made specific paediatric drug delivery systems. Moreover, from the perspective of the new European Union regulations on medicines for children (European Commission, 2006), the number of trials will increase in the future. Meanwhile, extemporaneous dispensing, even though it should remain the last resort, is still an important activity for paediatric pharmacists and carers (Yeung et al., 2004). 

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