Children's clinical drug trials now mandated in US

A new law in the US requiring new adult drugs to be tested for use in children could result in a three-fold increase in the number of pediatric clinical trials.

John Borchardt
Oct 9, 2000

HOUSTON. "We have inadequate information regarding the safety and effectiveness of drugs for children. As a result, children have not been equal recipients of the great advances in medicine and drug research," observes Mark S. Schriener, MD, medical director of the Children's Clinical Research Institute, part of the Children's Hospital of Philadelphia "Currently, only about 20% of the drugs on the market are well studied in children," he said. "That will change in December 2000 when a new law goes into effect requiring that all new drugs and new formulations of existing drugs be tested for use in children." The US Food and Drug Administration rule will require any new adult drug that could be used in children with the same disease to undergo pediatric study.

On a national level, some 180 pediatric drug trials are typically running every year. On the basis of the number of drugs approved in...

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