ABSTRACT

Properly conducted research is of course essential to modern medicine. Today there are higher expectations than ever that safe and effective treatments will be available for children’s illnesses. Improving the quality of care depends upon alterations to existing treatments and the search for new ones. It is also important to remember that treating children is not simply a question of adjusting the dosage of medicines. As the Medical Research Council point out, ‘[c]hildren are not small adults’, so that the process of diseases and their reaction to treatment can often only be understood in the context of the child’s growth and development. In addition, some conditions are specific to children, so research can only be undertaken with them (Medical Research Council, 2004, para 1.3). These factors are also noted in the European Directive on Clinical Trials 2001:

Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age and developmental related research important for their benefit. Medicinal products, including vaccines, for children need to be tested scientifically before widespread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant clinical value for children are fully studied.1