Understanding The Phases Of Clinical Trials

By James Streeter, Global Vice President, Customer Success

All new medical treatments undergo clinical trials, which are used to evaluate their safety, efficacy, and comparison to existing treatments. The studies are an integral part of drug development, yet they are often misunderstood. It is crucial to increase public awareness and understanding of clinical trials to dispel myths and misinformation. This allows patients to benefit from participation in studies and also helps develop new treatments to meet societal needs.

Phase 1 trials focus on evaluating the safety and dosing of the drug in a small group of healthy volunteers, whereas Phase 2 trials expand to a larger population and explore the efficacy and side effects of the drug in patients with the target condition. During Phase 3, trials further test the efficacy and side effects of the drug in a much larger group of patients and compare it to existing treatments. Lastly, a regulatory approval phase occurs, where evidence from the clinical trial is submitted to governing agencies for approval.

Access the full article for a comprehensive overview of how critical the role of clinical trials is in providing the evidence needed for regulatory approval, and the ethical considerations that should be considered during trial design and execution.