A clinical trial is a study that evaluates how well a new medical intervention works. Clinical trials can study treatments, screening procedures, and prevention methods. They’re important to cancer research because they allow doctors and scientists to learn about new cancer treatments. These new treatments may help patients who weren’t treated successfully with standard therapies. Clinical trials can also get newer, more effective, less toxic treatments approved for all cancer patients.
Deciding to participate in a clinical trial can be intimidating. But it’s important to remember that standard therapies are only available because patients were willing to participate in a clinical trial.
What are the stages of a clinical trial?
Clinical trials have four stages or phases that are usually conducted when studying possible treatments or drugs. The higher the phase, the more information there is on the safety and effectiveness of the drug.
- Phase 1: This is the first step in testing any investigational drug in humans. It’s usually the first time the drug or treatment has been given to humans. Normally, the treatment is given only to a small group of people. Phase 1 is for evaluating the treatment’s safety, determining a safe and tolerable dosage range, and identifying possible side effects.
- Phase 2: During phase 2, the drug or treatment is given to a larger group of people. This helps researchers to better understand its safety and effectiveness.
- Phase 3: This phase focuses on the effectiveness of the drug or treatment. It usually involves comparing the experimental treatment to the current standard treatment. Phase 3 trials usually involve a large amount of people.
- Phase 4: This phase usually takes place after the treatment or drug has been approved for standard use. It further evaluates the long-term safety and effectiveness of a drug. Phase 4 likely has numerous participants from multiple treatment centers.
Where can I find a clinical trial?
Your best resource for finding a trial that’s right for you may be asking your doctor. Many doctors keep up with ongoing research and may know of your options for clinical trials. If you’re considering looking into clinical trials as possible treatment options, let your doctor know.
Many websites are available to help patients find clinical trials that might be appropriate for them. Some of these websites are cancer specific. Others help patients with any diagnosis find a trial for them. Examples include:
- National Cancer Institute
- Bladder Cancer Advocacy Network
- NIH Clinical Trials Registry
- American Cancer Society Clinical Trials Matching Service
How do I know if I can participate in a clinical trial?
Clinical trials will share their inclusion criteria openly. You must meet certain criteria to be a participant. Some trials may also give a list of exclusion criteria. Meeting anything on the exclusion criteria list would mean someone isn’t eligible to participate. Before participating in a clinical trial, the research team will ask you many questions to make sure you meet their criteria.
If I join a clinical trial for a treatment, is there a chance I may be given a placebo instead?
A placebo is a harmless treatment (sometimes called a sugar pill). When placebos are used in clinical trials, the participants are usually randomly assigned to receive either the experimental drug or a placebo. Most often, the trial participants will not be told whether they’ll receive the study drug or the placebo. This is called a blind study.
In some cases, the scientist will also not know which participant will receive which drug. This is called a double blind study. The effects of the experimental drug or treatment are then compared to the effects of the placebo. This experimental design removes any psychological impacts on outcomes. This lets researchers more accurately test the effects and side effects of the drug or treatment.
Placebos are used very rarely in cancer clinical trials. Instead of giving a placebo, participants typically either get the experimental treatment or the “standard therapy.” The standard therapy is the recommended treatment for their specific cancer. This lets researchers see the impact of the experimental treatment, but ensures all participants get at least the standard treatment for their cancer.
Will my insurance cover the cost of a clinical trial?
The Patient Protection and Affordable Care Act mandates that most insurance companies cover the routine patient costs from clinical trials, as long as the following criteria are met:
- You meet the inclusion criteria and are eligible for the trial.
- The trial is an approved clinical trial.
- The trial involves in-network care.
Talk with your insurance provider before enrolling if you’re considering taking part in a trial. You can also talk with the research team for helpful information on navigating insurance.