About Research Studies
In order to provide new drugs to the public, pharmaceutical companies must test their investigational drugs very carefully through medical research studies (also called “clinical trials”). The United States Food and Drug Administration (FDA) thoroughly reviews the data collected in these studies before approving new medications for the public. Once the FDA approves a drug, many pharmaceutical companies continue to conduct research on the approved drug to collect ongoing safety and effectiveness data.
Study doctors are required to follow strict rules to protect the safety of the people who volunteer to participate in clinical trials. All researchers must follow a detailed plan, called a protocol, which explains all study procedures and has been reviewed and approved by an independent board (or group of people) that oversees the safety of all study participants. Additionally, before enrolling individuals into a study, researchers must fully explain the study to the individual and answer any questions he or she may have. Participation in a clinical trial is voluntary, and individuals may withdraw from the study at any time for any reason.