Phase-4 Clinical Interventional Study

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A Phase-4 Clinical Interventional Study is a human clinical trial that is conducted to evaluate the side effects of a new medical intervention/treatment after its use and marketing has been approved by a government's or ruling authority.



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  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_IV Retrieved 2022-01-15.
    • QUOTE:A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test.[1] Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be sold.[2] Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).[3] The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses; examples include cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).
  1. "The drug development process". US Food and Drug Administration. 4 January 2018. Retrieved 17 August 2020.
  2. "Types and phases of clinical trials". American Cancer Society. 18 August 2020. Retrieved 15 September 2020.
  3. "Step 3. Clinical research". US Food and Drug Administration. 14 October 2016. Retrieved 1 February 2017.

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