Challenges in conducting pediatric drug trials.

For many decades, and with the exception of the treatment of infections, drug use in children has been confined to symptom relief. But the emphasis in asthma treatment has now shifted to the use of antiinflammatory agents that prevent the process resulting in bronchoconstriction, thus removing a symptom's cause. Newer understanding from the use of antiinflammatory agents in adults has led to an appreciation of preventative therapy and a growing understanding that effective drug therapy during childhood could prevent changes in the disease process that lead to chronic symptoms during adulthood. Alongside these developments, and while the debate over conducting drug trials in children continues, a persistent gap remains in the knowledge about drug use in children. Challenges remain not only in the regulatory environment but also in research and in the identifying, recruiting, and fostering of pediatric investigators.