What is an example of a role of the FDA in clinical trials?

The role of the FDA in clinical trials primarily involves regulating the safety and efficacy of drugs. This regulatory function is crucial because it ensures that any new drug or treatment is proven to be safe for human use and effective for its intended purpose before it is allowed on the market. This oversight includes the evaluation of data submitted by trial sponsors, the review of clinical study protocols, and the monitoring of trials to ensure compliance with regulatory standards.

By requiring rigorous scientific evidence from clinical trials, the FDA protects public health by making informed decisions about which drugs can be approved for use in the general population. Their involvement includes setting guidelines for how trials should be conducted, reviewing trial results, and ensuring that manufacturers follow ethical standards in their research practices. This regulatory framework is vital for maintaining trust in the healthcare system and ensuring that new treatments are not only innovative but also safe for patients.