Clinical trials contribute to medical science and advance potential treatments to help manage your conditions now and in the future.
What are the different phases of clinical research studies (also known as clinical trials)?
Clinical research studies are divided into different phases. Each phase is designed to collect specific information about the investigational medication or treatment.
Phase 1 Trials
The first human tests of investigational medications or treatments are in Phase 1 studies. Phase 1 studies are designed to determine the most appropriate dose of the investigational medication and to check for any potential side effects. These studies usually involve a small number of participants and may involve a level of risk.
Phase 2 Trials
Phase 2 studies test the investigational medication in a larger group of patients to evaluate the effectiveness of the medication on the disease being studied and to confirm the safety data established in the Phase 1 study.
Many Phase 2 studies compare the investigational medication to a placebo (inactive medication) or an existing standard treatment. For clinical trials involving a placebo, participants have a chance to receive the investigational medication but also have a chance to receive the inactive medication.
As with every other study, patients in Phase 2 studies are closely monitored by the study team throughout their participation in the study.
Phase 3 Trials
In Phase 3 clinical research studies, basic information is known about the investigational medication from results collected in earlier studies. Phase 3 studies test the safety and how well the investigational medication works in hundreds or even thousands of participants. Phase 3 studies also often compare the investigational medication to a placebo (inactive medication) or an existing standard treatment.
Phase 4 Trials
These clinical research studies are conducted after the regulatory authorities have approved a medication and it is available for use by the general public. Phase 4 trials may evaluate the long-term safety of the approved medication.