FREQUENTLY ASKED QUESTIONS
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Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.
Each clinical trial defines who is eligible to take part in the study. Each trial must include only people who fit the patient traits for that study (the eligibility criteria).
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.
During a clinical trial, doctors, nurses, and other health care providers might be part of the treatment team. They will monitor your health closely. You may have more tests and medical exams than you would if you were not taking part in a clinical trial.
Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they’re widely available. If a new treatment is proven to work and you’re in the group getting it, you might be among the first to benefit.
The new strategies and treatments being studied aren’t always better than current standard care. Even if a new approach benefits some participants, it may not work for you.
Protecting the safety of people who take part in clinical trials is a high priority for clinical researchers. Each trial has scientific oversight, and patients also have rights that help protect them. In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices.
Informed consent is the process of giving clinical trial participants all of the facts about a trial. This happens before they agree to take part in the trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have. Before you decide whether to enroll in a clinical trial, a doctor or nurse will give you an informed consent form that presents the key facts of the study. If you agree to take part in the trial, you’ll be asked to sign the form.
Here are some questions to ask before enrolling in a clinical trial:
a. What is the purpose of the study?
b. What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful?
c. What are the possible risks, side effects, and benefits of taking part in the study?
d. How might this trial affect my daily life? Will I have to be in the hospital?
e. How long will the trial last?
f. Who will pay for the tests and treatments I receive?
g. Will I be reimbursed for other expenses (for example, time & travel)?
h. Who will be in charge of my care?
i. What will happen after the trial?”