From lab-bench to bedside
Clinical trials are a key step in the development of new treatment options, and they allow patients to get access to innovative therapies before marketing authorization.
Starting points for trials can either be promising research results from the lab, cell culture and pre-clinical models or the re-purposing of, for other indications already authorized, medicines. In both cases, a careful evaluation of relevance, feasibility and safety for the new patient cohort is essential. With their participation in clinical trials, patients become an essential part in drug development.
Depending on the scale and phase of the trial and available resources, several kinds of studies are conceivable. Study centres can conduct an academic trial themselves or out-license the trial to a specialized company. Furthermore, pharma companies often approach clinics with their request for participation in sponsored trials. The study protocol (detailed treatment and analyses plan of the trial) should be developed in close cooperation with competent authorities, ethics committees, patient advocacies and the pharma industry.