It was organized by the International Institute of Research and attended by pharmaceutical executives and government representatives. On the flip side, he said, there is a danger that drugs are withheld from children because doctors don't know enough about their action in that population. That is the basis for use of one of the commonest neonatology drugs in use today.
Theophylline is only one example.
Dr. Watts cited three reasons why drugs are not well evaluated in children. One is that it is difficult to do clinical trials in children because of the high level of protection by parents. The second reason is that the consent process is cumbersome, and the third is that regulations have discouraged clinical trials in children. There are few ethical guidelines that specifically relate to children in clinical studies, said Dr. Watts. At the moment, it hardly mentions children at all.