Clinical Trials for Cancer Patients
What is a clinical trial?
A clinical trial is a research study that helps us learn about new ways to prevent, find and treat cancer. The knowledge we gain from clinical trials can help improve the quality of cancer care over time.
Today, thanks to patients who volunteered for studies, the Rogel Cancer Center has a range of treatments that can cure or delay the progression of cancer for many years. For example, thanks to treatment breakthroughs discovered in clinical trials, we have seen the survival rate for Hodgkin’s lymphoma rise from about 15% in 1950 to nearly 90% today. We have also learned better ways to manage cancer symptoms through clinical trials.
Teaming up with patients who are willing and able to join trials is key to continuing this progress.
Our Focus
Clinical research focuses on finding new ways to improve health in people. This may include how to:
- Prevent cancer
- Find cancer
- Treat cancer
- Improve quality of life for people who have cancer
An example of how clinical trials improve the quality of life for people with cancer is explained by Dr. Jamie Mills in the video below. Dr. Mills treats people with pancreatic cancer -- a cancer that often goes undetected until its grown to a more advanced stage. Research, which includes clinical trials, has helped uncover more options for people with pancreatic cancer.
What do clinical trials study?
Clinical trials are research studies designed to answer questions about a potential new treatment:
- Is this new treatment safe to use in people?
- What is the right amount of the treatment to deliver the greatest impact on health?
- Will this new treatment benefit more people or help them live longer compared to the best known standard treatment?
- Will this treatment have fewer side effects than the standard treatment?
What are the 3 phases of clinical trials?
New cancer drugs or treatments must go through a series of 3 phases of clinical trials:
- Phase 1: researchers find out whether the experimental drug or treatment is safe for people and what side effects it causes.
- Phase 2: researchers use phase 2 trials to find out if the experimental drug or treatment is effective against a specific type of cancer.
- Phase 3: researchers test how the experimental treatment compares with the best standard treatment. If the experimental treatment works better or has fewer side effects than the standard treatment, it could be approved by the FDA for widespread use.
What is a Phase 1 clinical trial?
Why participate in a clinical trial?
Without clinical trials, there would be no new treatments for cancer. New cancer drugs or treatments must undergo rigorous testing under controlled circumstances to demonstrate they are safe and more effective than established treatments. The U.S. Food and Drug Administration reviews the results of clinical trials to decide whether a new treatment can be used more broadly.
There’s no guarantee an experimental treatment will cure your cancer or extend your life. That’s why it needs to be studied. Whether you receive any direct personal benefit, all research volunteers make an invaluable contribution to research. Many cancer patients who volunteer for clinical trials say they do it to help their children, grandchildren and others who may be diagnosed with cancer in the future.
Research scientists at the Rogel Cancer Center work hard every day to find new, more effective ways to treat, detect and prevent cancer. But they cannot do it alone.
By volunteering for a clinical trial, you become a partner in the discovery process. If you have cancer, it's a way to make an important contribution to the future of medicine that only you can make.
Key Facts you know about clinical trials?
To protect your safety, researchers must go through many steps to prove the treatment or intervention being studied is as safe as possible and might be better than standard treatments. This starts with many years of research in the lab, looking at how the treatment works in cells and animals.
For all clinical trials, the study team develops a detailed plan called a protocol, which explains how the study will work and the possible risks and benefits. The team also must get approval from an Institutional Review Board, or IRB. This group is tasked with protecting people who join studies. They review the plans and monitor the study to ensure safety.
If at any point, the research team or IRB suspects that the risks of the study intervention outweigh the benefits, they will stop the study immediately and you will be informed.
There’s no guarantee that a study treatment or intervention will benefit the participant. The study intervention may not cure your cancer or extend your life. But researchers will only offer a study treatment if they believe the outcome will be at least as good as the standard treatment.
Phase 1 and 2 trials test only the new treatment, which researchers believe might work better or have fewer side effects than standard treatments.
Phase 3 trials often assign people randomly to receive the new treatment or the usual treatment. The study is designed to compare how effective the treatments are.
When are placebos used?
A placebo is a harmless pill or injection that looks the same as the actual treatment but has no effect. These are rarely used in cancer care, but could be part of a study if:
- There are no known treatments that work (in other words, if standard treatment = no treatment)
- The new treatment is being added to a standard treatment. One group would receive the new treatment and the other would not, but both groups would be receiving the standard treatment.
The research team must tell you if a study uses a placebo.
When you join a clinical trial, you help add to our knowledge of the best way to prevent, find and treat cancer.
Many people join clinical trials because they hope the study treatment will help them more than the usual treatment. There is a chance this could happen, but it’s not guaranteed.
Every clinical trial helps us make progress. Even though researchers expect the treatment they are testing will be better, clinical trials are necessary to prove that.
Only you can decide if you want to participate in a clinical trial. Your doctor and research team can help you understand your options and answer questions about the study.
You should also discuss your options with family or friends. But in the end, consider your own goals and values to decide if a clinical trial is right for you.
What happens if I join a clinical trial?
You will be asked to sign an informed consent, stating that you agree to participate and understand the possible risks, benefits and costs. You can and should ask as many questions as you want and take the time you need to decide.
What if I later decide I want out of the study?
You have the legal right to withdraw from a clinical trial at any time for any reason. If you decide to withdraw, you can continue to be treated at the Rogel Cancer Center with the best standard therapies available for your type of cancer.
What happens if I choose not to be in a clinical trial?
You will still receive the best possible care for your cancer using standard treatments. You will not disappoint your doctor, even if they encouraged you to join.
Clinical trials are sponsored by federal agencies like the National Institutes of Health or by private pharmaceutical or biotechnology firms. The costs of the clinical trial and the experimental therapy are covered by that sponsor.
Your insurance plan will usually cover the cost of tests and procedures that are part of standard medical care.
Before deciding to participate in a clinical trial, it is important to know exactly what will be covered by the trial's sponsor. Ask your doctor or the research team and check with your insurance company before you agree to volunteer.
Will I get paid for being a study volunteer?
Most cancer clinical trials do not provide payment for study volunteers. Some trials do offer a small stipend or reimbursement for certain travel expenses, child care, lodging or lost wages. The study team will include this information in the informed consent document.
We need all types of people to enroll in clinical trials: young, old, all races and ethnicities. This is the only way we can make progress for all patients.
Anyone can develop cancer. Having a diverse group of participants helps us learn whether something works for all patients or just some. This is how we improve care for everyone.
What are eligibility criteria?
Eligibility criteria are rules are about who can and cannot join a trial. These rules
- Keep people safe
- Help researchers understand the results more clearly
Certain things can stop people from being eligible for a specific trial, such as having another disease or receiving a previous treatment.
Many cancer patients think they cannot participate in a clinical trial unless standard treatments stop working. This is not true. Many experimental drugs and treatments work best in the early stages of cancer. Whether you are newly diagnosed or poised to begin a new treatment, ask your doctor if a clinical trial is available for you.
Contact Us
If you have questions about clinical trials or need help finding one that’s right for you, talk to your doctor or call our Cancer AnswerLine at 800-865-1125. Our experienced oncology nurses are here to help and can guide you through your options.
