Related Articles
1. EUs Pediatric Regulation Sees First Approval:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Regulatory+News/EUs-Pediatric-Regulation-Sees-First-Approval/ArticleStandard/Article/detail/563284/
2. Making Reality of Pediatric Rhetoric http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+Articles/Pediatric-Policies-Grow-Up/ArticleStandard/Article/detail/439743?searchString=pediatric%20clinical%20trials/
3. Pediatric Policies Grow Up
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Trial+Design+Articles/Pediatric-Policies-Grow-Up/ArticleStandard/Article/detail/439743?searchString=pediatric%20clinical%20trials/
Sufficient pediatric information on medicines used in children should be available; thus, pediatric clinical research should
be enhanced. This is a consensus on a global basis and is now considered a public health priority. An increasing number of
clinical trials are expected due to emerging laws and guidelines and governmental support and funding.1
Some background
PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI
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Pharmaceutical companies are subject to market economy with assignment of limited resources to profitable products. Because
the rules of market economy are not sufficient to create a demand in pediatric research, there is a need for societal intervention.2 The first effective measure addressing this issue was realized in 1997, when the Food and Drug Modernization Act (FDAMA)
was adopted.
The measures of FDAMA encouraged companies to conduct studies of certain therapies being used in pediatrics by providing an
exclusivity incentive provision.3 Further regulations followed including the Pediatric Research Equity Act, enabling the FDA to force companies to study certain
drugs in children.4
Between 1998 and 2004, 253 studies were submitted to the FDA for pediatric exclusivity. Labeling changes were positive for
127 of the 253 studies (50%). As a result of these changes in regulations and legislation in the United States, more trials
have been done in children in these five years than in the previous 30 and there has been an improvement in safety information
as well as dose changes for pediatric prescribing.5
On January 26, 2007, 10 years after FDAMA was adopted, the European Pediatric Regulation 1901/2006 came into force.1 This regulation obliges the pharmaceutical industry to conduct clinical trials with children but can be waived for medicines
that are unlikely to benefit them. In some cases, studies may be deferred until the medicine has been authorized for use in
adults.
The manufacturers will be compensated by a six-month extension of the supplementary protection certificate for conducting
the pediatric development. In addition, there are programs that fund the pediatric development of substances without a supplementary
protection certificate.
The directive 2001/20/EC on Good Clinical Practice was adopted on the EU level in April 2001 and was implemented in Germany
in August 2004. The directive's aim was to simplify and harmonize administrative procedures governing trials to provide patient
protection by setting pan-European legal standards. Furthermore, the directive takes specific concerns into account regarding
clinical trials with children and specifies criteria for their protection as study patients.6
