Cancer touches all our lives in some way and finding a cure has been a major focus for medical researchers for decades.
There’s no miracle cure yet. Still, researchers continue to discover groundbreaking treatments that can be more effective and cause less side effects than current treatments, help improve quality of life and more. And clinical cancer trials are an essential part of the process.
“New discoveries can only be made because of a person’s participation in cancer research,” said Dr. Arek Dudek, a medical oncologist and leader of the Early-Phase Therapeutics Program at the HealthPartners Cancer Center at Regions Hospital.
Dr. Dudek, along with a team of investigators conducting cancer trials at all phases, is working hard to discover new treatments for the future, while improving care and offering hope to patients currently living with cancer.
But what is a cancer clinical trial exactly? How do they work? Who can take part in clinical trials? And what kinds of breakthroughs have come from cancer clinical trials? We answer all these questions and more.
First, what is a clinical trial?
A clinical trial is a research study to see how people with a medical condition like cancer, respond to a specific treatment. During a trial, a person receives treatment that hasn’t been approved by the U.S. Food and Drug Administration (FDA).
The goal of a research study is to show that new ways of treating or diagnosing a disease are safe and effective. Sometimes, researchers are testing whether a medication that’s available to treat one condition could also help another condition.
For example, researchers may start a study to see if a drug that’s approved for breast cancer also works in people with bone cancer. Other cancer clinical trials test new medications that haven’t been used in people before.
Are clinical trials safe for cancer patients?
Doctors and researchers do everything possible to make sure that cancer trials are safe at every stage.
“There are a lot of safety nets built into clinical trials, including extra monitoring and care coordination with a lot of different physicians and specialists,” Dr. Dudek explained.
But doctors and researchers don’t know everything that might happen during a clinical trial. It’s possible a treatment could be harmful or cause side effects. But because clinical trials are designed with safety in mind, they can be quickly stopped if the treatment’s not working or causing concerning side effects. That’s also why clinical trials are done in phases.
How long is a cancer clinical trial?
From start to finish, a clinical trial can take up to a decade to complete – or even more. But if you choose to be part of one, you wouldn’t participate the whole time. Instead, you’d be part of a particular phase of a clinical trial.
The road to breakthrough: Clinical trial phases
Clinical research is vital for providing people the best possible care and latest treatment options. For HealthPartners, this is one of our core values, helping us be a partner for good to our patients and the communities we serve.
Across our organization, our researchers lead hundreds of clinical trials on cancer and other conditions that affect people’s health and quality of life. And Dr. Dudek’s creation of our Early-Phase Therapeutics Program in 2015 has greatly expanded access to early-stage trials.
There are four main clinical trial phases, and each phase has a different goal.
Early-phase clinical trials
Phase I: Making sure treatments are safe
Phase I clinical trials are dedicated to making sure medicines or other treatments are safe for people.
“Researchers start with very low doses of the medication or therapy, and closely monitor patients for any signs or symptoms of problems,” Dr. Dudek explained. “Our methods are very scientific, and there are many checkpoints to make sure patients are as safe as possible.”
The goal is to find out the highest possible dosage that a person can receive without serious side effects. During this phase, researchers also begin to look for any activity or signs that cancers are responding to the treatment. If not, researchers may not continue to phase II, even if the medicine seems safe.
Most phase I cancer trials are very small, including about 15-30 people, and take less than two years.
Phase II: Seeing if a treatment works
Once researchers know a treatment is safe and shows signs of activity, they move on to a phase II trial to see how it works in fighting certain types of cancers. During this phase, they’ll also watch for less common side effects that they didn’t see during the first phase.
Phase II clinical trials usually take about 3-4 years to complete and include between 25-100 patients. If the results show the treatment can be effective without too many side effects, the study moves into a late-stage clinical trial. However, in some cases, researchers might request FDA approval based on phase II data.
Late-phase clinical trials
Phase III: Comparing to available treatments
During phase III trials, the safety and effectiveness of treatments are tested against the standard treatment for cancer. Standard treatments are the therapies that are currently used to treat a condition. For example, some standard treatments for cancer are surgery, chemotherapy and radiation.
“Phase III trials are usually randomized,” Dr. Dudek said. “This means that participants are picked at random to either receive the standard treatment or the new treatment.”
In some studies, the patient and even the researcher don’t know which treatment the patient is receiving – this type of study is called a double-blind.
Phase III studies can include hundreds or thousands of patients and take up to eight years. At the end of a successful phase III trial, the results are used to apply for FDA approval.
Phase IV: Finding more answers
Phase IV happens after a treatment is approved by the FDA. These studies are often used to make sure a treatment works as expected once it’s in widespread use. These trials may look at safety, side effects, cost effectiveness and quality of life.
The big question: Do clinical trials work to cure cancer?
Clinical trials haven’t led to a cure yet, but they have led to new treatments that help fight cancer in more effective ways, prolong life, improve people’s quality of life and more.
Of course, not all trials lead to a breakthrough – and this kind of research always carries risk. But that’s why researchers take a phased approach to clinical trials to determine which treatments are the safest, most effective and should be studied further.
Two of the most recent advances in treatment thanks to clinical trials are immunotherapy and medications that target specific cancer mutations.
The immune system is designed to detect and destroy abnormal cells – and it likely already plays a role in preventing or slowing many cancers. But some cancer cells find ways around the natural defenses of the immune system.
Immunotherapy engages the immune system in a new or boosted way to help fight cancer. And research shows this kind of therapy can be effective against cancer. There are several types of immunotherapy medications – and some are already FDA approved for certain cancers. But there’s much more to learn.
One of the most common approaches is a “basket trial” that tests a medication for safety and effectiveness across a variety of different tumor types to see how different cancers respond to the same medication.
Researchers working on the Early-Phase Therapeutics Program are currently involved in several early-stage clinical studies with different immunotherapy and chemotherapy medications.
Medications that target specific mutations
One example of a targeted therapy is one that targets mutated BRAF protein.
The BRAF gene is an oncogene that encodes the BRAF protein, which helps control cell growth. Depending on the body’s needs, the protein will turn on or turn off cell growth.
If you have a mutation in the BRAF gene, the resulting BRAF protein can’t stop cells from growing. This uncontrolled cell growth can lead to cancer. The mutations can be in different cells in different parts of the body – for example, in your colon or lungs.
The Early-Phase Therapeutics Program’s team of researchers is leading several clinical trials to determine if certain medications are safe and effective at targeting the BRAF mutations that affect cell growth. At this point, this approach is showing real promise in treating rare and difficult-to-treat cancers.
What you need to know about participating in a cancer clinical trial
The HealthPartners Institute is at the center of our research efforts. Within the Institute, several dedicated research centers partner with HealthPartners hospitals and clinics to integrate research into routine care.
Joanna Hill, MBA, CCRP is the director of the Institute’s Cancer Research Center. She works closely with research leaders like Dr. Dudek and cancer care teams across our hospitals, clinics and specialty centers to connect patients with clinical trial opportunities.
Who can take part in clinical cancer trials?
Clinical trials are a possibility for many people with cancer at different stages of their treatment plan. But not every study may be a good fit. The first things to check are the criteria for participation.
“Eligibility criteria are for the safety of the patient and to help control the clinical results,” Hill said. “This allows researchers to draw clearer conclusions about the safety and efficacy of a treatment.”
Here are the two types of eligibility criteria to be aware of:
- Inclusion criteria–These are the characteristics you must meet to be considered for a specific trial. For example, the study may be looking for people who have a certain type of cancer with specific tumor markers or genetic mutations.
- Exclusion criteria–These are attributes that you can’t have to be considered for a specific trial. For example, a common exclusion criterion is major surgery within four weeks of starting the clinical trial.
Who pays for clinical trials?
Medications or treatments being studied in the clinical trial are supplied by the trial sponsor, which is the person, company, institution, group or organization that creates the trial and oversees the process from beginning to end. In most cases, the trial sponsor also pays for other research-related costs such as special testing.
Routine tests, treatments and procedures needed during the clinical trial are covered by the patient’s insurance with the patient paying the usual out-of-pocket expenses.
Being in a clinical trial usually costs patients about the same amount as standard cancer treatment. But before joining a clinical trial, patients receive a document that shares what they’d need to pay for and what would be covered as part of the clinical trial.
Financial help with other expenses during a HealthPartners clinical trial
If you, your family members or support people need to travel to participate in one of our studies, the HealthPartners Foundation – thanks to generous donations from past patients, families and community members – offers financial assistance to help with travel, lodging, food and more. Plus, we’ve negotiated special rates with local hotels.
Where do clinical trials take place?
Clinical trials can take place anywhere that patients are treated, including hospitals, clinics, doctors’ offices and cancer centers.
Early-phase trials are usually limited to one or two locations since it’s important to have full control over the process to ensure the best patient care and the highest quality of data. For example, our early-phase trials are offered at HealthPartners Cancer Center at Regions Hospital in St. Paul, MN and HealthPartners Frauenshuh Cancer Center in St. Louis Park, MN.
In later phases of a clinical trial, hundreds of locations may be studying the same medication or treatment at the same time.
How do you find a clinical trial?
Again, clinical trials can be an opportunity for people with many different types of conditions and at different stages of their treatments. At HealthPartners, our care providers and research centers work together to connect you with possible trials.
Currently, we have dozens of trials accepting new patients and we’re constantly evaluating additional studies to take on.
Why should you participate in a clinical cancer trial?
There are many reasons people may consider being part of a clinical trial, but the most common are:
- After receiving concerning results from cancer screening, they want to understand all treatment options before committing to a specific path.
- Their doctor suggested a clinical cancer trial as a possible option when getting a second opinion on a cancer diagnosis.
- They’ve tried other treatments for their cancer, but they didn’t work.
- They’re having a difficult time coping with cancer treatment side effects and wondering if there’s an option for a better quality of life.
- They want to make a difference and contribute to new and better treatments for cancer in the future.
Is a clinical trial right for you?
Participating in a clinical trial is a personal decision. While your doctor can offer guidance and recommendations, you’re the only one who knows if a clinical trial is right for you.
The best first step is finding out whether you meet eligibility criteria. If you’ve found a trial that you’re interested in, review the criteria yourself to see if it may be a good fit. Then, call the research center in charge of the trial for next steps in confirming your eligibility.
When it comes to participating in a HealthPartners Institute clinical trial, we can walk you through the whole process and help determine your eligibility for a specific trial.
Better research leads to better care and new hope
Clinical research is essential to discovering new treatments that help us get closer to that ultimate goal of finding a cure for cancer. And the people who participate in research trials help us get there.
At HealthPartners, making it easy for people to find and participate in clinical research is important. This helps provide the best care and improve outcomes, while also bringing people with conditions like cancer hope – now and in the future.
Learn more about our commitment to being a partner for good.