Cancer Clinical Trials Frequently Asked Questions (FAQ)

Who can participate in a clinical trial for cancer?

To qualify for a particular study, participants must meet a carefully defined set of criteria. These usually include cancer type and sometimes subtype, stage of the cancer, and the types of treatments they have already received. Each individual trial usually has other criteria, but there is now a goal to make most trials as accessible as possible to increase opportunities for patients to be on a clinical trial and have the results applicable to a wide range patients in the future.

Learn more about eligibility criteria for clinical trials.

What if I’m not eligible for a clinical trial?

If you're not eligible for a clinical trial, you still have options. Your care team at Dana-Farber can guide you through alternative treatments that suit your specific needs. They are committed to finding the best possible care for you, whether through standard therapies or other innovative approaches outside of clinical trials.

What information do participants receive about clinical trials?

Before agreeing to participate, patients learn about possible risks and benefits of the therapy being studied. As the trial progresses, participants may learn new information about how the therapy is affecting their body and their disease that may affect their willingness to stay in the trial. Participants may withdraw from the trial at any time, for any reason.  

Learn more about the clinical trial process and what to expect.

How are patients protected?

Before any clinical trial begins, it must be approved by its host institution's Institutional Review Board (IRB), which includes researchers, physicians, members not directly associated with the institution, and non-scientists to give a more “lay” perspective. The IRB considers whether proposed studies are safe and well planned and whether they will ultimately advance patient care. It also reviews studies to evaluate potential risks and benefits of participation and if the potential benefits outweigh the risks. They will ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of each patient is closely monitored during the course of the trial.

Can I participate in more than one clinical trial at a time?  

As a general rule, patients can enroll in only one treatment clinical trial at a time. This is because trials are designed to focus on a specific therapy or treatment regimen. Participation in multiple trials would make it difficult for researchers to identify the risks and benefits of each therapy on its own.  

Patients may, however, participate in a biobanking or tumor-banking trial at the same time as they’re taking part in a trial of a new therapy. A tumor-banking trial involves collecting and storing tumor tissue for later analysis. Such analysis may help determine which tumors are most likely to respond to particular drugs, for example, or which tumors are at greatest risk of metastasizing.  

In some cases, patients can participate simultaneously in a treatment trial and a supportive care trial, which studies the effect of changes in diet or exercise. It is important to speak with your doctor and care team about clinical trials you qualify for, and whether you can participate in more than one at a time.  

How can I find the right clinical trial for me?

Finding the right clinical trial is an important step in exploring treatment options. At Dana-Farber, we encourage you to discuss clinical trial options with your oncologist. Your care team can provide valuable guidance and recommend specific trials available at Dana-Farber or nearby institutions.

Patients can also take an active role in searching for clinical trials:

• Explore Dana-Farber's clinical trial finder. This resource provides comprehensive information on available trials, helping you find options that align with your treatment needs.
• Search National Cancer Institute’s registry of cancer clinical trials at NCI-Designated Cancer Centers like Dana-Farber.

Additionally, pediatric patients may:

• See our early phase trials for children with relapsed or refractory cancer on the Dana-Farber/Boston Children's website
• Search for blood disorder clinical trials on the Boston Children's Hospital website

Advocacy groups like the American Cancer Society offer services to assist patients through cancer treatment and provide information about clinical trials. Online discussions hosted by these organizations can be a valuable source of shared experiences and insights.

For those seeking personalized guidance, hiring a patient advocate or navigator can be beneficial. These professionals help patients navigate the healthcare system and identify appropriate clinical trials, ensuring that patients have access to the best possible options for their treatment journey. 

Are clinical trials covered by insurance?

Coverage for clinical trials can vary depending on your insurance plan and the specific trial you are considering.  

Patients generally don’t need to pay for the treatments and special trial-related tests received during a clinical trial. Those costs are covered by the sponsor of the trial. Health insurance typically covers charges related to tests and treatments carried out during a clinical trial that would be done anyway for standard treatment.

Many states, including Massachusetts, require insurance companies to cover the cost of participation in a “qualifying cancer research intervention protocol.” Individuals who participate in research may still have to pay the deductibles associated with their standard of care treatment.  

You will learn about any potential costs of participation in the trial during the informed consent process. It's important to discuss the details with your insurance provider and your care team to understand what is covered and what costs you might incur. Dana-Farber's financial counselors are available to help navigate these questions and ensure you have a clear understanding of your coverage options.

I don’t live near Boston. Can I still participate in a Dana-Farber clinical trial?

In general, patients interested in participating in a clinical trial at Dana-Farber need to come to Boston for their care related to the trial. Clinical trials often involve complex treatments or procedures that must be done in a medical setting and monitored by a care team familiar with the clinical trial. Certain regulatory bodies such as the Food and Drug Administration (FDA) enforce strict controls for data and safety which mean that the trial cannot be done remotely.  

Our Dana-Farber researchers are committed to easing the burden of cancer treatment and will offer remote participation in activities such as questionnaires, surveys, and consents whenever possible.  

What happens if I change my mind about participating in a clinical trial?

You have the right to withdraw from a clinical trial at any time. Your participation is entirely voluntary, and you are not obligated to continue if you feel it's not the right fit for you. If you choose to withdraw, it's important to communicate your decision with your care team. They will guide you through the process and discuss alternative treatment options to ensure your ongoing care. Your decision to leave the trial will not affect the quality of care you receive, and your health and well-being will remain our top priority.

What are the risks and uncertainties in clinical trials?

Clinical trials involve testing new treatments, which can carry certain risks and uncertainties. While these treatments may offer potential benefits, they are still under investigation, and outcomes cannot be guaranteed. It's important to discuss the specific risks and potential side effects with your care team, who can provide detailed information and help you weigh the pros and cons of participation.

Are clinical trials a last resort?

A common misconception is that clinical trials are only for patients who have exhausted all other treatment options. While some trials are specifically for patients who have already tried everything, many trials focus on improving treatments at earlier stages in the cancer journey, including as first-line treatment. Clinical trials offer opportunities for a wide range of patients to access innovative therapies. 

Is the new treatment untested?  

Another misconception is that clinical trial participants are "guinea pigs" for untested treatments. In fact, clinical trials are based on extensive pre-existing research. Before reaching the clinical trial phase, treatments undergo rigorous laboratory and preclinical testing to ensure they are safe and potentially effective. By the time a treatment is offered in a clinical trial, it has already shown promise in earlier research stages.

Will I receive a placebo?

Many patients worry that participating in a clinical trial might mean receiving a placebo — an inactive substance delivered in the same way as the study drug — instead of an actual treatment. However, the use of placebos in cancer clinical trials is rare and typically only occurs under specific circumstances. 

Phase 1 Trials: In these trials, every participant receives the study drug. The primary goal is to determine the right dosage and assess the safety profile of a new drug or drug combination. There are no placebos involved, as the focus is on establishing how the drug should be administered safely.

Phase 2 Trials: These trials are disease-specific and aim to evaluate how well the drug works in a particular cancer type. All participants receive the study treatment at the determined dose and schedule, with no placebos used. The goal is to assess the drug's effectiveness in a specific patient population.

Phase 3 Trials: These are comparison studies where the new treatment is evaluated against a standard treatment or, in rare cases, a placebo. Placebos are only used when there is no existing standard treatment available. Typically, new drugs are compared to standard treatments, ensuring that most patients receive active treatment for their cancer.

Some trials that are testing new combinations of treatments might offer standard treatment plus the new treatment or standard treatment plus a placebo. In this case, the placebo is an addition to standard therapy.

If there is any possibility you might receive a placebo, that will be clearly communicated in the informed consent process. During this process, a member of the clinical trial team will explain the details of the trial to you, answer your questions, and make sure you consent to the process before enrolling you in the trial. It's important to discuss with your doctor the available standard treatments and the specifics of any clinical trial you’re considering. Understanding the trial's design and how it aligns with your treatment goals can help you make informed decisions about participation. 

Can I continue to see my regular doctor?

Yes, you can 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.

What support services are available while participating in a clinical trial?

The decision to join a clinical trial can be emotionally challenging. Patients may experience feelings of anxiety or fear about trying a new treatment. It's important to have open conversations with your care team, family, and support network to address these emotions. Many trials offer additional support resources, such as counseling and patient support groups, to help you manage the emotional aspects of participation.

What can be learned from clinical trials that fail?  

When a clinical trial shows that a new treatment is no better than the current standard, it can be disappointing. But such outcomes yield valuable, potentially lifesaving information.  

Trials can “fail” if the experimental therapy doesn’t work better than current treatments. These “negative” outcomes are important for several reasons. They can spare patients false hope or exposure to drugs with no value, and they can save researchers time and money spent pursuing treatments that are ineffective or too toxic.  

Some trials have found that standard therapy itself is ineffective. For example, it had long been common practice for women with early-stage breast cancer to have axillary lymph node dissection — removal of lymph nodes near the breast — to prevent the cancer’s spread. This procedure can lead to arm swelling known as lymphedema and other painful side effects. But clinical trial results published in 2011 revealed that women who had had their lymph nodes removed didn’t survive longer than those who didn’t have the procedure. These negative findings quickly led to a 50 percent drop in use of the procedure in such patients, according to a report published in 2016.  

What is MatchMiner and how is it used to “match” patients with clinical trials?

Dana-Farber offers a powerful tool called MatchMiner, which helps match patients with clinical trials based on the genetic mutations in their tumor cells. This tool is designed to streamline the process of finding suitable trials and is expected to become fully open source, benefiting patients and clinical trial leaders at other institutions.