Phase-4 Clinical Interventional Study

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.

• AKA: Postmarketing Surveillance Clinical Trail, Drug Monitoring Clinical Trial.
• Context:
  • It can (often) analyze side effects caused over time by a new treatment after it has been approved and is on the market.
  • It can (often) involve over 1,000 clinical study participants.
  • …
• Example(s):
  • ESKIMO Clinical Trial,
  • Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine,
  • …
• Counter-Example(s):
  • Preclinical Trial,
  • Phase-0 Clinical Trial,
  • Phase-I Clinical Trial,
  • Phase-II Clinical Trial,
  • Phase-III Clinical Trial,
• See: Approved Drug, Parallel Clinical Trial, Factorial Clinical Trial, Large-Simple Clinical Trial, Adaptive Clinical Trial, Superiority Clinical Trial.

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References

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#P Retrieved: 2022-01-15.
  • QUOTE: Phase IV clinical trial
    • After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial. (NCI)
    • Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. (NLM)

2021b

• (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. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be sold. 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). 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).

2021c

• (ClinicalTrials.gov, 2021) ⇒ https://clinicaltrials.gov/ct2/about-studies/glossary Retrieved 2022-01-15.
  • QUOTE: Phase 4: A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

2021d

• (Coursera, 2021) ⇒ "Design and Interpretation of Clinical Trials".
  • QUOTE: Phases I and II are often considered the learning phases of clinical trials, and phase III is considered the demonstration phase.

    Phase IV studies: these are studies of a drug or device after market approval. The objective of phase IV studies is to see how an intervention works in the real world and to examine long-term safety. Phase IV studies are frequently observational, but sometimes they are control trials.

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