Clinical Trials Questions & Answers

What are clinical trials?

• A clinical trial is a research study designed to test the safety and efficacy of a new therapy. They are funded by a variety of institutions/organizations. These include: pharmaceutical companies, government agencies, medical institutions, nonprofit organizations, etc.

What should I know about participating in clinical trials?

• Participation in a clinical trial is voluntary and you can withdraw from the study at any time.
• All information regarding your participation is treated as confidential.
• Clinical trials may last for several years.
• Each trial has its own specific criteria that participants must meet in order to enroll in the trial.
• Ask questions if you do not understand something.
• Be honest with the investigator regarding all aspects of the trial. Negative information is just as important as positive information.

What is informed consent?

• Informed consent is the process in which the clinical trial personnel (physician, nurse, or study coordinator) will explain to the participant the purpose, duration, required procedures, risks, potential benefits of participating in the trial as well as who to contact should additional questions/concerns arise. The participant then determines whether or not he/she wishes to participate. The participants' signature on the informed consent document verifies their willingness to take part in the trial. It is important to recognize that informed consent is NOT a contract and can be withdrawn at any time.

What government organization oversees clinical trials?

• The Food and Drug Administration (FDA) oversees clinical trials in the United States. The FDA is updated on a regular basis on the progress of the study.

Who pays for my health care while I am participating in a clinical trial?

• The sponsor of the study will pay for trial-related costs. Participants will not be required to pay any of these costs.