Risks and benefits of (pharmaco)epidemiology.

Pharmacoepidemiology is a relatively young scientific discipline that has seen tremendous growth in interest over the past two decades. This is partly due to changes in the approval of new drugs, which often now require proactive studies to monitor and extend the knowledge of safety in the postauthorization period. Pharmacoepidemiology studies are observational in nature, in contrast to the randomized controlled trial which is the mainstay of drug development. This means that such studies need careful design and execution in order to maximize the benefits of proactive research in the 'real-life' clinical environment and minimize the risks of false results.