Heart and Vascular Research: Frequently Asked Questions
Research studies and trials are important tools for advancing the state of diagnosis and treatment of heart and vascular diseases. Every year, some 2.5 million patients participate in clinical trials of all kinds. Many more patients may be eligible to take part in a study, but may not be aware of it or may have misunderstandings about participating. Below are some frequently asked questions about clinical trials.
Q. What is the purpose of a clinical trial?
A. Researchers are always trying to develop new ways to prevent and treat diseases and improve health. They conduct clinical trials to determine whether a new treatment will work and whether it will benefit patients. Many individuals volunteer to participate in these trials because they want to help advance medical knowledge.
Q. What kinds of clinical research do you conduct?
A. We conduct clinical trials, also known as interventional studies, as well as observational studies. A clinical trial looks at the 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 patients’ health outcomes.
Q. Who can participate in a research study?
A. Anyone can volunteer to participate in a study. The protocol determines whether the study requires healthy participants or participants with a certain disease or condition, as well as other criteria for eligibility, such as age, treatment history and other health history.
Q. Why might people choose to participate in cardiovascular research?
A. Often the reason for 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 he or she receives. 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 that 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 healthcare; and
Have the satisfaction of knowing that they helped advance the care of future patients.
Q. What safeguards are in place to protect patient participants?
A. You should know that researchers must adhere to the same ethical and legal codes that all physicians follow. In addition, an institutional review board (IRB) must review, approve and monitor all studies that are federally funded and/or regulated by the Food and Drug Administration (FDA). The IRB makes sure that 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 that you have. If you decide to enroll, you will sign the consent form, saying that you understand the study and agree to take part in it.
Q. Will I still see my regular doctor?
A. 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 for you.
Q. Where can I learn more about clinical studies?
A. You can learn more about clinical studies from the National Institutes of Health or from the Center for Information & Study on Clinical Research Participation. You can also call Lancaster Heart & Vascular Institute Clinical Research at 717-544-1777.