Ethical and safety aspects of clinical trials in neonates.

Clinical trials in neonates are essential in order to provide scientific evidence in relation to the efficacy and safety of medicines. European legislation has recently been passed in order to stimulate clinical research in this area. This should hopefully result in more licensed medicines in the neonatal period. It is essential that the clinical trials are performed safely and ethically and one therefore needs to be aware of predisposing factors for drug toxicity in the neonatal period.