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PaedRegCliNet e.V.: A Boost for Safe Pediatric Medications
Date:11/19/2010

ations for children.

Paving the way for clinical studies with children

But implementing this extremely positive endeavor has run into two major obstacles. "Because there have hardly been any clinical studies with children, many doctors at pediatric clinics do not have the necessary training," says Prof Dieter Adam. And that is why he founded the association PaedRegCliNet e.V. together with other pediatric specialists. It offers doctors at pediatric clinics one to two-day courses, which provide them with the basis for clinical studies in pediatrics, from the necessary infrastructure to the monitoring and implementation at testing centers. These courses were presented in detail at a symposium held at the Dr. Haunerschen Kinderspital of the University of Munich on September 29, 2010.

Ethical obligation overrides profit

The second problem encountered in implementing the Pediatric Regulation is finding a pharmaceutical company to finance the study. An EU proposal does contain a mention of assuming up to 50 percent of the costs of research on particular medications. "But for companies this does not appear to be attractive," explains Prof Adam.

"Compared to adults, children are not a revenue driver." He explained this fact by using the example of high blood pressure. A medication for high blood pressure approved for adults will be prescribed to millions of patients. If the medication is to be tested to see if it is safe for babies who suffer from high blood pressure due to a congenital heart disease, there are only a few thousand young patients worldwide who would be prescribed this medication. This is why PaedRegCliNet e.V. is also committed to finding pharmaceutical companies, raising awareness of the EU regulation and to underscoring the ethical obligation.

Lowering the costs of the studies

In an effort to keep the costs of the studies as low as possible and to consequently burden pharmaceutical companies as little
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SOURCE PaedRegCliNet. e.V.
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