Clinical Trials Unit
The Emergency Clinic of Turku University Hospital provides a safe environment for early-phase clinical trials of pharmaceuticals. In the current regulatory guidance for First-in-Human trials, issued by the European Medicines Agency in 2007, requirements are defined for the safe conduct of such studies in terms of trial facilities, investigators and staff. The Emergency Clinic is capable of housing demanding early-phase clinical trials in a safe environment because of its advanced patient monitoring systems, qualified staff and close proximity to the Intensive Care Unit of Turku University Hospital.
GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRST-IN-HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS, EMEA/CHMP/SWP/28367/07
"First-in-human trials should take place in appropriate clinical facilities and be conducted by trained investigators who have acquired the necessary expertise and experience in conducting early phase trials (i.e. phase I-II) and medical staff with appropriate level of training and previous experience of first-in-human studies. They should also understand the investigational medicinal product, its target and mechanism of action.
Units should have immediate access to equipment and staff for resuscitating and stabilising individuals in an acute emergency (such as cardiac emergencies, anaphylaxis, cytokine release syndrome, convulsions, hypotension), and ready availability of Intensive Care Unit facilities. Procedures should be established between the clinical research unit and its nearby Intensive Care Unit regarding the responsibilities and undertakings of each in the transfer and care of patients."