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Pediatric Clinical Trials

The new European directive on children's pharmaceuticals which became effective on January 1, 2007 will help children and adolescents to obtain more specially approved pharmaceuticals. Thereby the number of pediatric clinical trials has been increasing over recent years so that children can benefit from medical progress, but the development of medicines for their pediatric use is more complex and the ethical implications are more intricate compared to clinical trials for adults.

Children are different

Clients who are conducting clinical trials with children and adolescents should be aware that children are not just little adults from a medical point of view. This particular patient population is more vulnerable. Differences in reabsorption, volume of distribution, metabolism and elimination of the pharmaceutical product have an enormous impact on the bioavailability in children. In addition, the pediatric patient population is diverse because age and stage of development are important influence factors. This must be taken into account in order to prevent them from being exposed to unnecessary risks during the study.

Therefore pediatric clinical trials are different

Managing clinical trials with children requires special diligence and knowledge of the specific requirements. Therefore pediatric clinical trials have to be approached differently during each step of the development plan and the trial implementation.

At the beginning patient diversity has to be considered regarding sample size calculation and analysis plans. The assessments in the protocol should be both child- and parent-friendly as one of the main challenges is patient recruitment and retention. CONET ensures that investigators are trained diligently and understand their responsibilities with pediatric specific consent and assent issues.

Many other specific requirements have to be considered like intensive involvement and education of parents regarding their obligation to study procedures but also their special needs regarding scheduling of the visits and respecting school hours, for example. A more active management of the Ethics Committee process is necessary as safety aspects are under special observation in this vulnerable patient population.

Safety is of special concern in pediatric clinical trials

Doses which are safe and effective in adults normally cannot be simply adjusted to children, as children have a different physiology than adults. Therefore clinical studies are conducted to investigate safe and effective dosing in children. Discovering adverse events that may be specific to children and long-term risk-benefit analyses are of particular interest in pediatric studies.

CONET will support you in the development of solutions for your products in pediatric use.

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