Phase Iv Clinical Trial (Noun)
Meaning
Sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials.
Classification
Nouns denoting acts or actions.
Examples
- The pharmaceutical company was required to conduct a phase IV clinical trial to assess the long-term safety of their new medication in a larger and more diverse patient population.
- The FDA mandated a phase IV clinical trial to evaluate the efficacy of the new cancer treatment in pediatric patients, as it had only been tested in adults during the earlier trials.
- The phase IV clinical trial was designed to monitor the drug's performance in patients with mild versus severe symptoms of the disease, as well as its effects on patients with pre-existing medical conditions.
- During the phase IV clinical trial, researchers collected data on the medication's potential interactions with other commonly prescribed drugs, which had not been thoroughly investigated in earlier studies.
- The phase IV clinical trial revealed a rare but serious side effect of the medication that had not been detected in the smaller, earlier trials, prompting the manufacturer to update the warning label.