CLINICAL TRIALS PHASE 4

 

INTRODUCTION: Post-Market Drug Safety Monitoring: Phase 4 trials are conducted when the drug or device has been approved by FDA. These trials are also recognized as post-marketing surveillance involving pharmacovigilance and continuing technical support after approval. There are numerous observational strategies and assessment patterns used in Phase 4 trials to evaluate the efficacy, cost effectiveness, and safety of an involvement in real-world settings. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive purposes or other reasons. Therefore, the true illustration of a drug‘s safety essentially requires over the months and even years that mark up a drug‘s lifespan in the market. FDA reviews reports of complications with prescription and OTC drugs, and can decide to add precautions to the dosage or practice information, as well as other events for more serious adverse drug reactions.

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