Clinical trials or Medical Research are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
-NIH-May 17, 2017
Phases of Clinical Trials
All Clinical Trial Studies must be approved by the U.S. Food and Drug Administration (FDA) before the intervention is tested in Humans. The process takes 4 phases. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
The 4 Phases are:
Phase 1: Tested in small group of healthy subject to determine the safety, side effects and correct dosages.
Phase 2: Similar to phase 1 but tested on a larger group with specific condition mostly to determine effectiveness of the new treatment.
Phase 3: This is a larger scale study where the the new medication or device is tested at different dosages for efficiency, side effect, drug-to-drug interaction and safety. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase 4: This last phase takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
