Drug Safety Monitoring In Children: The Need For Development Of Appropriate Data-mining Methods

Historically, new drugs have usually been tested in only adults before they have approved for use. Children have usually been excluded because of ethical reasons, yet such drugs are administered to them following approval.

Adverse effects can occur following drug use. Examples of major drug disasters include the thalidomide disaster that occurred in the early 1960`s, and the observed increased risk of suicide following use of anti-depressants. Children are more prone to advserse effects because: (1) features of diseases in children are different from the features of similar diseases in adults (2) children have immature tissues and organs (3)chronic childhood diseases require long-term treatment, resulting in potential adverse effects that can change/worsen in characteristics as children grow and develop.

Consequently there are new legislations globally, all aimed at increasing the generation of direct evidence of drugs in children. One good way of achieving this is secondary use of data collected in the course of routine medical care (Electronic Healthcare Records) or collected via Spontaneous Adverse Event Reporting. However appropriate methods need to be applied to extract the best evidence possible from these data. Yet such methods are not available presently. Therefore the development of appropriate data-mining methods remains vital to the synthesis of direct evidence of the effects of drugs in children.