Maybe you’ve been talking to your doctor about clinical trials to treat a particular condition, researching clinical trials for a loved one or just generally curious about how they work. Use this guide to help clear up some questions you might have.
What is a Clinical Trial?
Clinical trials are an important part of clinical research, helping doctors and researchers study and fine tune medical advancements before they can be used more widely.
We have numerous clinical trials going on throughout our health system focused on conditions ranging from heart disease to diabetes to cancer.
These trials help experts investigate new ways to prevent, detect or treat disease using:
- A new drug or a different combination of existing drugs
- A new medical device
- A new way to use an existing treatment
- A new method for surgery
- A new change to a patient’s behaviors, diet, routine, etc., to impact their health
Through clinical trials, researchers can determine if these methods are safe and effective.
Clinical trials are conducted in phases and may enroll patients in each phase:
- Phase I – A small group of people (less than 100) participate in the trial for the first time to help evaluate its safety and to identify any side effects.
- Phase II – A larger group (100 to 300) participate in the trial to further determine its safety and effectiveness.
- Phase III – The group size expands again (1,000 to 3,000) to provide a larger cross-section of the population and compare its effectiveness and side effects with existing treatments.
- Phase IV – Once the treatment option is approved by the FDA, it is further researched in clinical trial patients to gather more information about its side effects, benefits and its best use.
Who Can Participate in a Clinical Trial?
Clinical trials aren’t all limited to those who are sick. Healthy volunteers can participate in certain clinical trials based on their eligibility and specific health requirements, usually to help determine how a method impacts a healthy patient versus a sick patient.
Some clinical trials offer payment for participation.
People with a specific illness or disease might take part in a clinical trial at the recommendation of their doctor or seek a clinical trial out themselves for an alternative treatment option.
Clinical trials are voluntary, and you are able to leave the trial at any time. Researchers are also required to be transparent and clear with you about every aspect of your participation, including potential risks, and must get your consent before continuing with each step of the trial.
What’s the Benefit to Patients?
Patients who have been recently diagnosed with a certain condition or who are already receiving treatment for a condition may benefit from a clinical trial.
Those benefits can include:
- The opportunity to try a new treatment that isn’t yet available on the market with the hope that it might improve their health and quality of life.
- An alternative option for patients who haven’t seen positive impact or improved health from existing treatment options.
- Participation can be integrated into your regular care. For instance, data collection, blood draws or other aspects of your clinical trial participation can take place during regular checkups so you don’t have to schedule additional visits.
- Clinical trials essentially expand your care team to include researchers and other medical experts who are paying close attention to your health — adding another layer of support so you can get the best and safest care.
Why are Clinical Trials Important?
When you volunteer for a clinical trial, you are helping to innovate for the future of medical treatment. Doctors and researchers rely on clinical trial patients to help steer their research and lead to important advancements in medical care.
This ensures that other patients or even you will soon have the best possible treatment that healthcare can offer.
“The lifeline of effective clinical research is the patients who volunteer to participate,” says Hollis “Bud” O’Neal, MD, medical director of research at Our Lady of the Lake Health. “What we guarantee when you participate in research is that you will get the best treatment.”
The National Institutes of Health has more resources about clinical trials as well as questions to ask your doctor.
How to Join a Clinical Trial?
First, talk to your primary care provider or specialist about whether a clinical trial is right for you. They can share suggestions and recommendations on specific clinical trials that are available.