Why are new drugs monitored during Phase 4 trials?

New drugs are monitored during Phase 4 trials primarily to gather data on their best usage and to assess potential long-term effects. This stage follows the initial phases of clinical trials, where the safety and efficacy of the drug are evaluated in controlled environments. Phase 4 trials take place after a drug has been approved and is available to the public, allowing for ongoing evaluation in a broader population.

During this phase, researchers can observe how the drug performs in real-world settings and among diverse patient demographics. This information is crucial because it helps to identify any rare or long-term side effects that may not have been evident in earlier trials. Additionally, Phase 4 studies provide insights into optimal dosing regimens, effectiveness across different populations, and potential interactions with other medications. This ongoing assessment ensures that the drug remains safe and effective for its intended use as it is utilized in everyday healthcare settings.