Before introducing new medicines to the public, pharmaceutical companies must test their investigational drugs very carefully through medical research studies (also called “clinical trials”). Global regulatory agencies thoroughly review the data collected in these studies before approving new medications for the public. Once a drug is authorized, many pharmaceutical companies continue to conduct research on the authorized drug to check it is still safe and effective.

Study doctors are required to follow strict rules to protect the safety and well-being of the people who volunteer to participate in research studies. All researchers must follow a detailed plan, called a protocol, which explains all study procedures and has been reviewed by an independent board (or group of experts) 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 research study is voluntary, and individuals may withdraw from the study at any time for any reason. Participants may or may not benefit from the investigational drug.