Frequently Asked Questions
What is clinical research?
Clinical research is medical research that involves people. People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments, medical devices and therapies.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Trials can also help others better understand how the treatment works in people of different races and genders. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
Who participates in clinical trials?
Many different types of people participate in clinical trials. Some are healthy, while others may have illnesses. A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Healthy volunteers have always played an important role in research.
A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.
Patient volunteers may be involved in studies similar to those in which healthy volunteers participate. These studies involve drugs, devices, or interventions designed to prevent, treat, or cure disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment.
What are the risks?
Some treatments that are being tested may have side effects that can be unpleasant, serious, or even life-threatening. Because the treatments being studied are new, doctors don’t always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and all known risks should be fully explained to you by the researchers.
How am I protected?
To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent.
Informed consents must be written in language that you understand. If you don’t, be sure to ask the study doctor or research staff to explain it. Make sure you understand all of it before you agree to be in the study.
Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is not a contract and you can leave the study at any time, for any reason.
Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the rights and welfare of the participants are protected. An IRB is an independent committee that consists of doctors, lay persons and members of the community not affiliated with the research institute.
What happens after a clinical trial is completed?
After a clinical trial is completed, researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase 1 or 2 trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase 3 trial is completed, the researchers examine the data and decide whether the results have medical importance. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.