Research that includes humans is clinical research. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. There are many different forms of clinical research. One common form is a clinical trial. In a clinical trial, researchers test new drugs, medical devices or treatments.
Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs, new surgical techniques, devices, or biological products. Clinical trials are also conducted to test cutting-edge and novel therapies, like studies that involve gene therapy or gene transfer.
Clinical trials must be conducted before a new drug, biologic, or device may be marketed in the United States. The FDA regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions.