An exploratory clinical trial is a type of clinical trial that is designed to gather preliminary data on the safety, effectiveness, and/or mechanism of action of a new medical treatment, drug, or device. Exploratory clinical trials are typically small in size and are conducted early in the drug development process, before the treatment has been fully characterized.
Exploratory clinical trials are often used to:
Exploratory clinical trials are usually conducted in a Phase 1 or Phase 2 setting, and are often the first time that a new treatment is tested in humans. The results of exploratory clinical trials are used to determine whether the treatment should be further developed and tested in larger, more definitive clinical trials.
A confirmatory clinical trial is a type of clinical trial that is designed to confirm the safety and effectiveness of a new medical treatment, drug, or device. Confirmatory clinical trials are typically large in size and are conducted later in the drug development process, after the treatment has shown promise in earlier studies.
Confirmatory clinical trials are usually conducted in a Phase 3 setting, and are designed to provide definitive evidence of the treatment's safety and effectiveness. They are typically randomized, controlled trials that compare the experimental treatment to a control treatment (such as a placebo or an existing standard of care) in a large group of patients.
The results of confirmatory clinical trials are used to determine whether the treatment should be approved for use in clinical practice. They are also used to inform the development of clinical practice guidelines and to support the marketing and use of the treatment.