MUNICH, November 19, 2010 /PRNewswire/ -- Many of the medications used to treat children have been developed almost exclusively for adults and approved for them. This is why pediatricians have been demanding for decades that medications be tailored specifically to the needs of the child's body and adequately tested on children. A regulation from the European Commission called the Pediatric Regulation has set out to solve this problem. Clinical studies involving children should ultimately give way to medications tailored for this age group. The studies include not only testing substances from adult medications especially for children, but also the additional development and testing of entirely new medications 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 as possible, the specialists are striving to shorten the studies or to perform them with as few young patients as possible. To do this, they are using archived patient data in pediatric clinics on the so-called "off-label application" of adult medications. If there is no other way to save the health of the child, the doctors have to use these medications even without specific approval for children. "We plan to view and anonymously assess the files in question," states Prof Adam about the project. Some medications often prove to be effective and safe for many thousands of young patients. If one then considers these facts in a clinical study, it can be carried out with significantly less effort. Unfortunately, government organizations have not yet agreed to offer financial support to this project.
The non-profit organization PaedRegCliNet e.V. was founded in 2009 and is committed to promoting the development of medications for children and to supporting this through its own projects. As a member, you help ensure that children across Europe are given adequately tested medications.
More Information: PaedRegCliNet e.V. Jurgen Wyen Tel.: +49-89-55155358 Fax: +49-89-55155359 Juerge.Wyen@PaediaCRO.de
|SOURCE PaedRegCliNet. e.V.|
Copyright©2010 PR Newswire.
All rights reserved