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Clinical trials are research studies designed to answer scientific questions and discover better ways to prevent, diagnose, or treat various diseases and conditions. A clinical trial is one of the last stages of a long and careful process. Scientists begin by developing and testing new ideas in a laboratory. If a treatment seems promising, the next step may be testing it in animals to learn how it affects the disease in a living being and if it has harmful effects.
Treatments that work in a lab or in animals may not always work well in people. When a potential treatment seems safe enough to try in humans, it proceeds to be studied in a clinical trial. These trials are done with patients to learn whether promising treatments are safe and effective.
The most successful treatments today are based on what we have learned from clinical trials. As a result, people with various diseases are living longer and with a better quality of life.
Every treatment we have today was tested in a clinical trial to make sure it is safe and works well for people. Clinical research has led to the discovery of the disease treatments prescribed today.
Only 3 to 6% of cancer patients who are eligible to participate in a clinical trial do so — resulting in over 90% of cancer patients possibly missing out on potentially life-saving treatments.
That doesn’t have to be you.
Clinical trials provide patients with access to new therapies that could become the future standard of care.
— Cancer Research Institute
If you are interested in joining a clinical trial, the research team and your provider are your go-to sources, but here are the answers to some of the most common questions:
*Note that we use “treatment” when answering these questions, but the same answers can be used for clinical trials studying how we provide care, such as blood tests or imaging.
I’ve seen trials listed as “Phase 1” or “Phase 2.” What does that mean?
Clinical trials are divided into four phases. Each phase is designed to answer certain types of questions to help researchers understand the treatment’s safety and effectiveness.
- Phase 1 trials aim to find the safe dose of a drug, how it should be given (e.g., by mouth, through a vein), and how the treatment affects the human body and fights cancer. During Phase 1 trials, researchers find the highest dose of the drug that can be given safely, without causing severe side effects. These trials usually involve about 15 to 30 people.
- Phase 2 trials look for benefits of the treatment, such as if a tumor has shrunk or disappeared, or quality of life has improved. Like phase 1 trials, these trials also look at how the drug affects the human body and fights cancer. Phase 2 trials generally involve less than 100 people.
- Phase 3 trials compare the new treatment with the current standard treatment. Often, these are randomized trials — some trial participants are picked at random to receive the new treatment, while other participants receive the old one. When possible, this is done as a double-blind study, which means that neither the researchers nor the participants know which treatment they are receiving. Anywhere from 100 to a few thousand people participate in phase 3 trials.
- Phase 4 trials study the long-term safety and effectiveness of the new treatment. They take place after the treatment has already been approved by the US Food and Drug Administration (FDA) and is on the market. These studies address unanswered questions. For instance, a drug may have been approved for reducing the risk of cancer returning, but it might not be clear whether or not someone taking the drug lives longer. Phase 4 trials also look for rare or long-term side effects that may not have been seen in earlier phases.
What are the benefits and risks?
Sometimes patients enroll in a clinical trial to get early access to what could be a promising therapy.
Several of the benefits include:
- Helping others who have cancer by being part of advancing research
- Getting early access to what could be a promising therapy
- Feeling more in control of your own health
- Perhaps seeing your provider more often to more closely monitor your cancer
However, there are no guarantees that the therapy will work or that they will be assigned to the group of patients who get the therapy. Patients may be assigned to a comparison group instead that receives another approved treatment or placebo (a pill with no medication). The new treatment may also cause additional side effects. That is why a treatment may be offered in a trial where doctors can monitor patients very closely.
Are clinical trials safe?
We understand you or your loved ones may be nervous about joining a clinical trial. However, we do everything in our power to protect the rights, safety, and welfare of all UI Health patients participating in clinical trials.
Clinical trials follow strict federal safety regulations. You will be protected through:
- Informed consent: This is a process where you will be given all of the information about risks and benefits upfront so that you will know exactly what you’re agreeing to do.
- Careful review and approval by scientific experts and the Institutional Review Board (IRB). The IRB is a group of providers, scientists, and people from the community who ensure that the trial is legal, ethical, well-designed, doesn’t put participants at any unnecessary risk, and includes a patient safety plan.
- Ongoing monitoring by the IRB, Data and Safety Monitoring Boards (experts who review data throughout the trial), the research team, and the UI Cancer Center.
You can leave the trial at any time — no questions asked.
How are clinical trials different from getting regular treatment?
When your doctor needs to prescribe a treatment for you, they prescribe an approved treatment that is the standard of care for your disease or condition. If there is a clinical trial available for your condition, it may have two or more different treatments that you could be assigned to. One treatment will always be the standard treatment. The other treatment will usually be the standard treatment plus the new treatment. By the time a potential new treatment is available through a clinical trial, this means that doctors have a reasonable idea that it could be beneficial for patients with your condition now or as the future standard of care.
Being part of a clinical trial means you will never receive anything less than the standard treatment. You will just have the chance to get a potential new treatment in addition.
What about costs? Can I get paid to participate?
The costs of any drugs or care are covered by your insurance or the clinical trial’s sponsor. There can be some costs to you — such as transportation and childcare from any additional doctor’s visits or tests. In many cases, there are ways of helping you with these costs.
Participants are not paid for participation in cancer clinical trials. However, if the clinical trial involves substantial additional time than you would need to spend for receiving your usual treatment, you may be compensated for this additional time. You will be informed of any compensation available to you for participation when the research team explains the study to you as part of the informed consent process.
What if I decide I don’t want to participate in the trial anymore?
You can leave a trial at any time for any reason.
How do I know if I’m a good candidate for a trial?
There isn’t one type of ideal candidate. It depends on the specific trial and what the researchers need to study. For example, some of the factors that may determine eligibility for certain trials include:
- Demographics, such as your age, sex, race, ethnicity, or where you live
- How you are responding to and any side effects you’re experiencing from your current treatment
- Treatments you have tried in the past
- Your cancer stage
- Your type of cancer
Do not stop any current treatment in order to participate in a clinical trial without talking to your physician.
The research team and your providers will work together to make sure that you’re not just right for the trial, but that the trial is right for you.
Why should I be part of a clinical trial?
Participating in clinical trials at UI Health may not only benefit you but also could help future patients through the development of new, safer treatments. To make sure the FDA has a full picture of the risk or benefit of a medical product, patients enrolled in trials should be representative of patients who will likely to use the medical product in the future. Having diverse clinical trials helps the FDA understand how new medical products may help or affect groups of future patients, such as:
- People of color
- Underserved populations
- Older people
If I join a clinical trial, is there a risk that I won’t be given any treatment at all?
It is true that in some types of clinical trials, some people are given the drug being studied while others are given a placebo (something that looks like the drug but is inactive and has no effect on the body). However, when it comes to clinical trials for cancer, placebo trials are not very common.
We will never keep you from getting the best-known treatment for your cancer just because you’re part of a trial. Our priority is providing care and helping you heal. A trial will not stand in the way of you receiving the best quality care.
Who do I talk to if I want to be part of a trial?
Your doctor may already have a trial in mind and may ask you if you would like to participate. You also can ask your healthcare provider to find out if there are any clinical trials that may be right for you. You can look for clinical trials to participate in by visiting the National Library of Medicine’s website at www.clinicaltrials.gov.
To learn more about trials, contact the UI Cancer Center Clinical Trials Office:
What other resources are available to learn more about clinical trials?
Diversity in Clinical Trials: How UI Cancer Center is Fighting Cancer Disparities
From family history to a person’s living environment to a lack of access to healthcare, there are many reasons why disparities exist in cancer care. One of these reasons is the lack of diversity among participants in clinical trials.
Many diseases affect people of different races and ethnicities, which is why clinical trials are more effective if the participants represent all types of patients. However, minority groups are significantly underrepresented among clinical trial participants.
Diversity in Clinical Trials
- Black people make up 13.4% of the US population, but only 5% of all clinical trial participants.
- People of Hispanic or Latino origin represent 18.1% of the U population, but only 1% of all clinical trial participants.
- Less than 5% of breast cancer studies look at race and socioeconomic factors when drawing conclusions from the study’s results.
- Over 96% of prostate cancer clinical trial participants are non-Hispanic white men — despite the fact that 22% of prostate cancer diagnoses are in non-Hispanic Black men.
Sources: The American Journal of Managed Care (2020), JAMA Oncology (2019), Clinical Research Pathways, Oncology Nursing Society
Increasing diversity is essential to improving cancer care for all patients. Having diverse clinical trials helps the FDA understand how new medical products may help or affect groups of future patients, such as:
- People of color
- Underserved populations
- Older people
At UI Cancer Center, our goal is to eliminate disparities in cancer care — and one way we do that is by increasing representation of minority groups in our research. The Cancer Center and UI Health serves a highly diverse population, and many of our clinical trials draw on participation from our patients. This allows us to make a direct impact on our diverse community and reduce disparities in cancer research.
“Research is very important. Clinical trials — they’ve got to have people to test it on. How are we going to advance? How are we going to get a cure for this thing if people don’t participate in the research?”
Carol Gyimatey, UI Cancer Center Clinical Trial Participant
To find a clinical trial at UI Cancer Center currently enrolling patients, please see the UI Cancer Clinical Trials Clinical Trials listing.
For more information about cancer clinical trials, please see the following resources:
- Food & Drug Administration
- National Institutes of Health
- National Cancer Institute (NCI): Clinical Trials Information for Patients and Caregivers
- The American Cancer Society: Clinical Trials
- Cancer Support Community: Cancer Clinical Trials