A clinical trial is a carefully designed study that is done with volunteers who receive investigational medical treatments. The volunteers are closely monitored by doctors and research professionals. The treatments are developed by pharmaceutical companies who select physicians to conduct the trials. Through these trials, the benefits of investigational drugs may be shown.

Once you have enrolled in a clinical trial (also known as a study), you may receive a physical examination and other assessments. Your study doctor or a research staff member will also review your medical history. A detailed description of your specific clinical trial and what’s to be expected of you will be outlined in an informed consent form. Your safety and privacy are always a priority.

Informed consent means that study volunteers understand the details of their clinical study before agreeing to participate. Participants must be provided with all the facts about a study, including treatment details and possible risks and benefits. They must sign an informed consent form before they participate. In addition, participants must be kept informed of any changes that could affect them during the clinical trial.

Phase 1 studies typically last between one and two weeks. Phase 2, Phase 3, and Phase 4 studies can last several months to several years. In most studies, in-person visits to our center are required.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help answer different questions: In Phase I trials, researchers give a drug or treatment under study to a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to evaluate its safety. In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and to evaluate its safety. In Phase IV trials, post marketing studies seek additional information including the drug’s risks, benefits, and optimal use.

After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug is effective, safe, and if it has any side effects. FDA medical advisors and specialists closely review this data before approving any new drug. ​