What is a clinical trial?A clinical trial is carefully monitored research, conducted on humans prior to the release of a new medicine. New medicines must have proven their safety and efficacy in humans before they find their place on the pharmacy shelf.
Before a medicine is tested in a clinical trial, it has been tested and researched in the laboratory. This research is used to gather knowledge about the potential benefits and limitations before the medicine is tested in humans. All medicines tested by CCBR have already been tested on smaller groups of healthy volunteers (phase 1). The medicines tested by CCBR need then to be tested in larger numbers of volunteers.
To ensure that clinical trials are conducted in accordance to the applicable rules of the participant’s rights, safety and wellbeing, it must follow a specific plan called a protocol. The protocol is approved by the National Board of Health and the Research Ethics Committee. The approval from the National Board of Health is based on the documentation gathered during the trials. Without clinical trials documenting a sufficiently high efficacy and safety of a medical product, it will not be approved for sale.