Researchers are always trying to develop new ways to prevent and treat diseases and improve health. They conduct clinical trials to determine if a new treatment will work and benefit patients. Many individuals volunteer to participate in these trials because they want to help advance medical knowledge.
We conduct clinical trials, also known as interventional studies, as well as observational studies. A clinical trial looks at outcomes in groups of patients who are assigned to receive different treatments, according to a research plan or protocol. We may do this to determine if a new approach works as well as an existing one, or which of two approaches is more effective. In an observational study, researchers monitor things like patients’ lifestyle choices, risk factors or treatments and then try to determine the impact of these factors on health outcomes.
Researchers must adhere to the same ethical and legal codes all physicians follow. In addition, an institutional review board (IRB) reviews, approves and monitors studies that are federally funded and/or regulated by the Food and Drug Administration (FDA). The IRB makes sure the study minimizes risks, and balances risks against potential benefits.
When you are considering enrolling in a study, you will receive a consent form, which explains the potential risks, benefits and alternatives to the study. The research team will review these with you. You should ask any questions you have. If you decide to enroll, you will sign the consent form, confirming you understand the study and agree to take part in it.
Often the purpose of a clinical trial is to determine the safety and effectiveness of a new treatment. At the start of the study, we don’t know which treatment is better or whether an individual will benefit from the treatment. In fact, even at the end of a study, we don’t always know whether individual participants ended up with better outcomes than they would have experienced if they had not taken part in a clinical trial. For these reasons, it is important to understand you have a chance to benefit directly from participation, but we do not know if you will. Participants often take part because they want this chance, and because they want to help advance medicine.
People who take part in clinical research:
- Have access to investigational treatments before they may be available to the general public
- Receive close monitoring and evaluation by health professionals so changes in condition are addressed as soon as possible
- Play an active role in their own health care
- Have the satisfaction of knowing they helped advance the care of future patients
In most cases you will still see your usual health-care provider. You will also have visits with research staff. Research visits may be coordinated with your regular care to make them more convenient.