Applied Clinical Trials-07-01-2002

Applied Clinical Trials

Why Aren't More Pediatric Trials Performed?

July 01, 2002

Feature Article

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

Letters to the editor

July 01, 2002

Letters to the Editor

Readers respond to articles and editorials.

Practical and Ethical Issues in Pediatric Clinical Trials

July 01, 2002

Feature Article

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.

FDA, Congress Spur Pediatric Drug Development

July 01, 2002

View from Washington

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.

Pediatric Clinical Studies in Japan: Regulations and Current Status

July 01, 2002

Feature Article

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

No Orphans Among European Children?

July 01, 2002

View from Brussels

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

Ron Keeney

July 01, 2002

Meet the EAB

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