For Patients & Caregivers

How are clinical trials created?

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or healthcare providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

Are clinical trials safe?

The U.S. Food and Drug Administration (FDA) works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because those conducting trials are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. Also, discuss the trial with your healthcare provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:

• What happens during the trial?

• The type of healthcare you will receive

• Any related costs once you are enrolled in the trial

• The benefits and risks associated with participating

What is the FDA’s role in approving new drugs and medical treatments?

The FDA makes sure medical treatments are safe and effective for people to use. They do not develop new therapies or conduct clinical trials. Rather, they oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.