Since the tragedies in the early days of the pharmaceutical industry, such as the deaths linked to the administration of sulfonamides in the 30’s or the malformation due to thalidomide in the 60’s, the laws and regulations have been modified concerning clinical testing in order to ensure the safety and efficacy of pharmaceutical products in man. However, these clinical trials have been beneficial mostly for adults. In children the safety and efficacy of about 50% of the medical products routinely utilized have not been tested.
A clinical trial conducted in the Intensive care unit of the CHUV illustrates this fact: Two small children hospitalized with a severe enterococcal infection did not respond to imipramine treatment despite the fact that the strain was sensitive to this antibiotic. The recommended dose, extrapolated from the adult dose, was not sufficient. Following this observation the clinical trial, which was conducted, showed that in order to obtain efficacious concentration in children the dose had to be doubled compared to the recommended dose.
As opposed to fundamental research, applied clinical research has the objective of being applicable in the short term. Principally it consists of dose optimization of pharmaceutical products, development of diagnostic methods and therapeutic protocols, and adaptation of equipment. The results are published in international journals so that all the medical community can take advantage.