The Drug Development Timeline
Once a promising compound has been identified, pre-clinical research is done which often involves testing the compound in model systems, like kidney cells grown in culture or, in the case of PKD, animal models of cystic disease.
Once the compound has completed pre-clinical testing, it moves on into clinical trials in humans. The purpose of a clinical trial is to test a new drug or other intervention for safety and effectiveness in treating the disease in question before it can be prescribed for patients. The Food & Drug Administration is the federal agency charged with oversight of all the clinical trials going on in the U.S. at any time. Click here to learn more about clinical studies.