CLINICAL TRIALS
Clinical trials are completed on human subjects. Clinical trials are not started until a considerable amount of pre-clinical work has been completed and there is evidence that the compound is potentially safe for use in humans.
When conducting clinical trials, the safety of the human subject is paramount. The two main safeguards for human subjects are the institutional review boards (IRBs) and the informed consent process.
Clinical trials are divided into phases: I, II, III, IIIB and IV.
In Phase I trials the investigational drug or biological compound is given to humans for the first time.
Phase II trials are initiated after suffiecient safety data has been collected from the phase I trial. Phase II trials are rigid, well-controlled studies in a relatively small paitent population.
Phase III trials demonstrate the long-term safety and efficacy needed to assess the risk/benefit relationship of the drug.
Phase IV trials are done after the approval of the new drug application by the FDA. Phase IV studies determine additional information about the safety or efficacy of the compound.