What is a clinical trial?
A clinical trial is a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, vaccines, biologics, treatments, medical devices, or new ways of using known drugs, vaccines, biologics, treatments or medical devices). Behavioral interventions are intended to prevent or treat an acute or chronic disease or condition.
Checklist for Applicable Clinical Trial
Effective April 18, 2017, the FDA and NIH have expanded their regulations and policies for the governance of Clinical Trials.
Clinical trials are done to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. There are four phases of clinical trials and each phase is designed to answer a specific and separate research question.
To test a new drug or treatment in a small group (20-80) of people for the first time to evaluate its safety; determine a safe dosage range; and identify side effects.
To test the drug or treatment in a larger group (100-300) of people to see if it is effective and to further evaluate its safety.
The drug or treatment is given to large groups (1,000-3,000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
These studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and determine what, if any, side effects are associated with long-term use.