Clinical Trials - Phase IV
Phase IV trials are post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. It also involves post-launch safety surveillance and ongoing technical support of a drug, helping detect long term adverse effects in a larger population. In situations where adverse effects are detected the durgs usage may be restricted or at times even withdrawn.
Phase IV studies can be conducted either by regulatory authorities or by the Pharmceutical company sponsoring the drug either for competitive or other reasons.