Clinical Trials And Its Effects On The Public Health Care Arena

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Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine related problem.” Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes and safety. Its peripheral importance lies in contributions to cost effectiveness and risk management in the public health care arena. Responsible and aggressive implementation of adverse event reporting procedures promote awareness and value to the importance of the identification of harmful effects of medication use.
The stages of pharmacovigilance coincide with the stages of clinical trials. Each stage of a clinical trial has a pharmacovigilant component. The preclinical phase which is restricted to animal testing is the first stage of research and development that determines safety. Once a compound is determined to be safe in laboratory animals and has potential to be therapeutic in humans, it can be considered for Clinical Trials. Phase 1 of a clinical trial is primarily to evaluate a new compound’s safety in general and therefore is conducted with less than 100 participants which are expected to be healthy. If the Phase 1 safety profile suggests a low risk factor for a drug, Phase 2 and 3 studies continue with the

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