Applied Clinical Trials-07-01-2002

Successful pediatric research requires partnership between the pharmaceutical industry, investigators, ethics committees, and parents.

Readers respond to articles and editorials.

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

Sponsors are underwriting more studies of children, but controversy continues over the need for FDA?s pediatric rule and the impact of extended exclusivity on generics.

In Japan, pediatric clinical trials face obstacles, but new regulations give manufacturers incentive to conduct them.

The European Union is working to develop pediatric rules to ensure that medicines prescribed for children are safe, effective, and of high quality.

At work and play, he?s devoted to children.