Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: Saltzer Clinical Research participates in Phase II – IV trials. The trial protocols are designed by the sponsoring pharmaceutical company, then distributed to sites like ours to recruit subjects for them. The trials are closely monitored to ensure that the physicians are following the protocol exactly as written and make sure the data we report is accurate. Physicians (Principal Investigators) and study coordinators are required to report all adverse events that occur while a person is on a study whether or not it is related to the drug or not.
In Phase I trials, researchers test an experimental drug or treatment in 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 further evaluate its safety in the population of patients it is intended to treat.
In Phase III trials, the experimental study drug or treatment is given to an even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use or to compare two FDA approved drugs to each other. After a drug is FDA approved, it is still studied in Phase IV trials.