A cancer clinical trial is a research study that is designed to test new ways to treat cancer. Trials test a range of possibilities, from treatment, devices, and diagnostics to screening, approaches to prevention, and other forms of intervention.
Clinical trials determine if a given intervention is safe and effective and are essential for improvements in cancer medicine.
“All of the medicines and approaches that we use to treat cancer are available because they were tested in clinical trials and shown to be better than the previous standard,” says Adrienne Waks, MD, associate director of Breast Oncology Clinical Research at Dana-Farber. “At Dana-Farber, we’re always interested in doing better than the standard, and the way that we do that is we test new approaches and new medicines in clinical trials.”
If you are considering a clinical trial, here are some questions to ask your doctor to help you to learn more about whether there is a trial that is a good option for you.
When is the right time for me to consider a clinical trial?
You can consider joining a trial at any time. Your doctor can help you determine if there is a trial available that would be a good match for you.
“It is always a good time to consider a clinical trial,” says Waks. “One important myth to debunk is that clinical trials are only for people who don’t have other options.”
Patients typically join treatment-focused trials when they are ready to initiate a new treatment, but trials exist for patients with all kinds of needs. For example, if you are newly diagnosed with cancer, there might be a clinical trial available testing a new approach to the very first treatment you receive for your condition. Similarly, after your primary treatment is complete, there might be trials offering approaches to maintaining your health.
Who is in charge of my care on a clinical trial?
Doctors, researchers, research coordinators, research nurses, support staff, and other health care professionals work together in planning your care on a clinical trial. Your immediate care team will expand to include a research nurse. You can also continue to see your regular doctor while participating in a clinical trial. Your primary care physician or oncologist will remain an integral part of your healthcare team, working alongside the trial team to ensure comprehensive care.
It is important to know exactly who your key contacts are. Ask questions to get clarity if needed.
“I want to know who is in charge of my care, how my local care team will receive information, and who I should call if I have concerns,” says Elizabeth Ormiston, who is a patient advocate from northern New York who was treated for early-stage breast cancer at Dana-Farber and is now participating in a clinical trial at Dana-Farber.
How am I protected?
Before any clinical trial begins, it must be approved by its host site’s Institutional Review Board (IRB), which includes researchers, physicians, members not directly associated with the site, and non-scientists. For a trial to be approved, the IRB must find that the proposed studies are safe, well planned, and will advance patient care.
During the trial, your safety is the top priority. The research team will closely monitor you for any side effects or adverse reactions to the treatment. You’ll have regular assessments to ensure that any issues are quickly identified and managed. Your care team will provide guidance on how to handle side effects and adjust your treatment plan if necessary.
What is it like to be on a clinical trial?
Before enrolling in a clinical trial, there will be a screening process to determine if you are eligible for the trial. Eligibility requirements help ensure patient safety.
Another step in trial participation is informed consent, where an expert explains the trial’s purpose and procedures and answers your questions. Signing the consent form indicates that you understand and agree to participate.
Participation in the clinical trial might not differ much from receiving standard therapy, though every trial is different. Like standard therapy, trials often require scans and tests to make sure the treatment is working. These may include blood tests, imaging scans, and other diagnostic procedures. Regular check-ins with your care team ensure that any changes in your health are promptly addressed.
The schedule will be outlined at the start, so you will know what to expect in terms of frequency, duration, and locations of visits. In addition, on a trial your care team will expand to include a research nurse and others who will assist with your care.
“Research nurses and social workers can help you understand the trial and the logistics so you can make a decision that is right for you,” says Ormiston.
Could I end up getting a placebo?
Cancer clinical trials rarely have patients receive only a placebo, which is an inactive treatment. Two examples of more likely scenarios include studies that compare the standard treatment, which is the currently accepted best available treatment, with a new, investigational drug or treatment, or studies that test different doses of an investigational drug.
If there was any possibility you might receive a placebo, that would be very clear in the informed consent process. For example, some clinical trials will test a combination of a standard medicine plus a new medicine against a combination of the standard medicine plus a placebo. The only time a placebo would be used alone is if there is no current standard treatment available.
“I suggest asking questions about the science behind the trial,” says Ormiston. “Ask why they are doing the trial, what they hope to learn, and why they think it will benefit you.”
Learn common myths about clinical trials.
What if I change my mind about participating in a clinical trial?
Clinical trials are voluntary, and you can stop trial treatment at any time. Your doctor can help you learn more about how to make changes if desired.
“Patients sometimes think they are strapped into a clinical trial, but they can leave any time for any reason,” says Waks.
If your current treatment is not working for you, or if the side effects are unacceptable, your care team will adjust your treatment or consider an alternative. This is true whether you are participating in a trial or not.
How do I find and enroll in a clinical trial?
There are many clinical trials enrolling now, and new trials are always starting. Ask your doctor if there are any trials that might be a good match for you.
Not every trial is available at every care center, so your doctor might need to refer you to a specific cancer center to access a trial. Clinical trials are typically offered at large cancer institutes like Dana-Farber Cancer Institute. Dana-Farber is uniquely qualified to run clinical trials because it has the expertise, resources, and infrastructure to support clinical research of all kinds.
- See a list of clinical trials available at Dana-Farber.
- See a list of clinical trials available to cancer patients nationwide.
You might also consider a second opinion, for example, through Dana-Farber’s Second Opinion Program. Dana-Farber specialists provide second opinions and may find trial options that would be a good match for you.
If you find a clinical trial that seems to be a good match, the trial team will help you understand more about what participation entails, get your consent, and begin any screening required prior to enrollment.
Get answers to frequently asked questions about clinical trials.