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PaedRegCliNet e.V.: A Boost for Safe Pediatric Medications

November 19, 2010

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.


Source: newswire



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