The HeartBrothers Foundation recently welcomed Dr. Amanda Vest, director of the Advanced Heart Failure Program at Tufts Medical Center, to discuss the importance of clinical trials as tools to develop new disease treatments. They include trials that examine a new drug, a new medical device, or a new diagnostic procedure, as well as new ways to perform surgery. Patients who are considering taking part in a clinical trial, she said, should be aware of regulatory thresholds and protections that are put into place when a study is about people and health.
“As researchers, we entirely understand that none of these advances could be done without the time and generosity of research participants,” said Dr. Vest.
A clinical trial involves changing a patient’s care plan to compare new treatments to the current standard of treatment. Participants are assigned to two or more different strategies for diagnosis or treatment. How they are assigned will affect the treatment strategy. “There is enough expectation that the different strategies could be equal to make it fair and reasonable to do a trial,” said Dr. Vest. Clinical trials are highly regulated by the U.S. Food and Drug Administration (FDA). They also must be reviewed, approved, and monitored by review boards like institutional review boards at hospitals. The board will vet possible risks and communicate risks to study participants. They are also monitored by independent data and safety monitoring boards.
Clinical trials go through phases. By the time most of us learn about a clinical trial, it has reached phase three and involves hundreds or thousands of participants. Even after licensing and approval, clinical trials can continue to investigate safety, side-effects, and the efficacy of the treatment.
Dr. Vest discussed TTR-related amyloidosis (ATTR), a rare condition where abnormal proteins build up in the heart chamber and cause heart failure. She noted that, as a result of a clinical trial, cardiologists now screen for ATTR. There is currently one approved treatment and several more are still in the clinical trial phase.
Participants in clinical trials have a right to and should expect to be informed. They should have adequate time to review the informed consent form and full discussion or risks and benefits. Participants can withdraw from study at any time. New information, such as a side effect just discovered, should be shared with those taking part in the trial. There is also an expectation of privacy and confidentiality. If data is going to be shared, the patient should be told.
All clinical trials are logged with the government. You can research them at ClinicalTrials.gov. If you are thinking about taking part in a clinical trial, ask your doctors and nurses if they think you could be a good candidate. The Heart Failure Society of America – hfsa.org – is also a good resource to check.
Some clinical trials offer compensation. If a patient needs a test that they usually do not receive but is required for the trial, the study should cover the cost. If the trial is observing the results of tests the patient usually receives under their health plan, the health plan should continue covering those costs.
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