What is a clinical trial?
Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for human use. These studies may also show which medical approaches work best for certain illnesses or groups of people. Many of the treatments and medications used today were made possible by past clinical trials and the patients who participated in them.
Why should I consider participating 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 are widely available. If a new treatment is proven to work and you’re in the group receiving it, you might be among the first to benefit. Even if you don’t directly benefit from the results of the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer to participate in a clinical trial because they want to help others.
Are there any risks involved?
Since clinical trials are conducted to determine the effectiveness and safety of a new medical strategy, treatment or device, there can be some risks and downsides. For example, the study may find that the new strategies and treatments aren’t any more effective than the current standards for medical care. Or a new approach may benefit some, but not all participants in the study. There can also be side effects that the doctors don’t know about or expect.
How does a clinical trial work?
Each clinical trial has a master plan called a protocol that describes how many patients participate in the trial, who is eligible to take part, the tests or procedures patients will participate in and how often and what type of data will be collected during the trial. The protocol also includes detailed information about the treatment plan and safety procedures.
Patients who are considering participating in a clinical trial are thoroughly informed about the nature of the trial, how it will work and any risks and potential benefits. Participation in a clinical trial is always voluntary and a patient may stop participating in a clinical trial at any time for personal or medical reasons. If are currently participating in a clinical trial and would like to stop, talk to your research team to find out what steps need to be taken to start the formal process of ending your participation.
What are the types of clinical trials?
Clinical trials are performed for many different reasons. They may be used to evaluate new ways of preventing disease, to study ways to detect and diagnose disease earlier or more accurately, to test the effectiveness of current treatments or new treatments. They may also be used to explore ways to improve the comfort and quality of life of patients and look for new ways to decrease the severity of side effects caused by their ailments and treatments. Clinical trials may also be performed to determine how a patient’s genetic makeup can affect the detection, diagnosis or response to a disease treatment or to study the role of genes in the development of disease in certain populations. At Yuma Regional Medical Center we currently conduct clinical trials in both oncology and cardiology.
Who sponsors a clinical trial?
Clinical trials are sponsored by government agencies such as the National Institutes of Health (NIH), pharmaceutical companies, individual doctors, health care centers and organizations that develop medical devices or equipment. If the trial is being conducted to test the safety of a product such as a medication, it is overseen by the U.S. Food and Drug Administration (FDA). Strict standards are established and must be adhered to at all times.
Who manages the patient’s care during a clinical trial?
Each clinical trial is managed by a research team that can include a doctor (also known as the principal investigator (PI)), a pharmacist, nurse, coordinator and other qualified research staff who will work closely together to monitor the health of the patients taking part in the clinical trial.
How is the patient’s safety protected during a clinical trial?
Patient safety is our number one priority at Yuma Regional Medical Center. All clinical trials that are conducted or supported by agencies of the U.S. federal government or those that evaluate new drugs or medical devices that are subject to regulation by the U.S. Food and Drug Administration (FDA) must be reviewed and approved by an Institutional Review Board (IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety and wellbeing of trial participants will be protected. Some trials also use an independent Data and Safety Monitoring Board (DSMB) to monitor the safety and progress of the trials.
How long does a clinical trial last?
The length of a clinical study varies, depending on what is being studied. Before patients enroll in a study, they are informed about how long it will last.
Who is responsible for the cost of care for participants in a clinical trial?
The costs of care for people participating in a clinical trial fall into two general categories. Routine care costs, which are costs associated with treating a person’s disease or condition, whether or not they are in a trial, are usually covered by health insurance, but coverage varies by state and type of health plan. The second category is research costs, the costs associated with conducting a clinical trial. Many clinical trial sponsors may provide the treatment or procedure being studied for free, as well as cover the cost of tests needed for data collection. However, the treatments, tests and procedures are provided free of charge depending on the trial. It is important for patients to talk with the clinical trial research team to obtain a clear understanding of what costs are – and are not – covered by insurance or the trial sponsor. Your research team will review this information with you in detail.
Does Medicare cover investigational medical devices and related services in a clinical trial?
It depends on the category the medical device falls within as determined by the Centers for Medicare & Medicaid Services. Category A includes experimental/investigational devices for which there is no Medicare coverage. Category B includes devices that are non-experimental and are eligible for Medicare coverage. Payment for covered Category B devices and related services will be based on, and may not exceed, the amount that would have been paid for a currently used FDA-approved device and related services serving the same medical purposes.
What happens after a clinical trial is completed?
Once a clinical trial is completed, the researchers carefully examine the information that was collected during the study before making decisions about the meaning of the findings and about further testing. For some trials, the researchers will decide whether to move on to the next phase or to stop testing the treatment or device because it was unsafe or ineffective. Results from clinical trials are often published in peer-reviewed scientific journals. Before the report is published, it is reviewed by experts to ensure that the analysis and conclusions are sound. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical care for the condition being studied.
For general information about Institutional Research at Yuma Regional Medical Center, please call 928-336-3366
. To find out if you may be eligible for a current clinical trial
speak to your physician.