It takes about 15 years and $millions to bring a new medicine to market. Great care is taken to evaluate new treatments on adults to ensure safety and efficacy while balancing side effects with benefits to health. The process for testing medicines for children is tightly regulated and all research protocols must be submitted for Ethics Committee/Institutional Review Board (IRB) scrutiny and approval before trials can start.
Amazingly, it has not until recently been a legal or regulatory requirement to test medicines for children. There are excellent guidebooks on paediatric prescribing complied by paediatricians, based on years of clinical experience and academic research. Most of the time children get better without a problem. But what happens when a child needs treatment but the prescribing guidance is lacking?
“The health of children may suffer as, when a doctor writes a prescription for an untested unauthorised product, that doctor can not be sure the medicine will be truly effective, what dose is appropriate or exactly what the side effects will be”. References 1,2
The ethical and research needs of children are very different from that of adults. Paediatric clinical trials need to be tailored to the patient group as well as the disease and therapeutic area. Children are vulnerable and may not have capacity to assent for themselves.
Children are not small adults and respond very differently to medicines at various ages and stages of development. Nobody would allow children near medicine cabinets for fear of them getting the wrong dose. Is it not equally unwise to give children medicines that have not been properly tested? However moves have been made to rectify this and a new paediatric regulation is now in force, mandading companies to perform paediatric clinical trials.
Paediatric clinical trial challenges - need for training
There are significant challenges to performing studies in children. Paediatric trials are fraught with ethical and practical difficulties and take much longer to do than clinical trials in adults. Pharmaceutical companies therefore have to justify expensive paediatric trials to shareholders for a perceived smaller financial return compared to adult medicines. But with the addition of new Member States in Europe there are now approximately 100 million children who will need safe, effective medicines.
With the new European Medicines for Children Regulation in force, pharmaceutical company research staff not used to working with children may find themselves with steep learning curves.
However, with training and planning it is possible to save costs on the learning curve (usually associated with poorly designed protocol leading to slow recruitment and poor compliance).
Please click here for details about in-house training offered by Paediatric Research Consultancy.
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