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Paediatric clinical trials

Paediatric clinical trials are planned right from the start so that any possible risks and stress are kept to a minimum, and that reliable results are obtained with as few study subjects as possible.

Clinical trial protocols are designed especially for children and adolescents, paying particular attention to restrictions resulting from age, body size and state of health. For instance, the number of blood samples must not exceed the limits set for children based on their age and size. When carrying out trials, the daily routines of the study subject must be taken into account as well as those of his or her guardian or even of the entire family.

According to international ethical principles and agreements, children cannot be enrolled into clinical trials as healthy volunteers. Generally, paediatric clinical trials are conducted on patients who are suffering from the illness that is being investigated. Clinical trials can, however, be conducted on healthy children and adolescents if preventative medicinal treatment, e.g. vaccination, is being investigated, and which can prevent serious infectious diseases in children and adolescents. In such case, a healthy child directly benefits from the trial by avoiding the illness.

The following effects of investigational medicinal products are investigated in clinical trials:
  • absorption
  • distribution
  • metabolism
  • excretion (out of the body)
These factors are investigated at several study phases

All phases are planned carefully and the plans include specific safety limits need to be followed, according to which the trials can be interrupted based on the statistically threatening number of adverse events observed. The investigated medicinal products are registered and granted Marketing Authorization only after all the phases (1.-3.) has been appropriately conducted and respective final results have been obtained. Aftert the medicinal products are placed on the market, it is possible to continue the research with postmarketing safety studies (4.).

  1. In the first phase (Phase I), the tested medicinal product is administered, under strict supervision, generally to a few healthy adult volunteers (in some cases only to patients). According to the results obtained from these tests, a safe and appropriate starting dose of the medicinal product can be determined also for children.
  2. In the second phase (Phase II), the medicinal product can be tested on the right patient group involving more subjects – no more than few dozens. At this phase the concentration levels and right dosages for best results are investigated.
  3. In the third phase (Phase III), large-scale trials are conducted, including even thousands of pediatric patients (or healthy children in preventive vaccine trials). The overall aim is to collect enough data to confirm the efficacy and safety of the medicinal product.
  4. Trials can also be conducted after the marketing authorization has been granted. Safety and efficacy of the approved product is followed in postmarketing trials known as Phase IV trials, which can be conducted e.g. in order to compare the medicinal product to other authorized medicinal products with the same indication.