Clinical trials are the main way scientists develop new and improved cancer treatments. Yet less than 5 percent of adults with cancer participate in clinical trials, and most who do are white. Disparities in clinical trial participation among Black women could be one of the reasons they have worse breast cancer outcomes than other racial and ethnic groups in the United States.
For this Breastcancer.org Special Report, we spoke with experts and clinical trial participants about why diversity in clinical research matters, and how you can overcome common barriers that may be preventing you from participating in a breast cancer clinical trial.
For more general information about clinical trials, including what they are and how they work, visit our Clinical Trials pages.
- Karen’s story: A clinical trial saved my life
- Why are people of color underrepresented in clinical trials?
- Sharon’s story: Finding a trial on my own
- Why diversity matters in cancer research
- Saysha’s story: Joining a trial to help others
- Improving access to clinical trials
- Common challenges (and solutions) to joining a clinical trial
Karen’s story: A clinical trial saved my life
A month before her 50th birthday in 2015, Karen Peterson, a single mom and former social worker from Harlem, New York, learned that she had stage I breast cancer. She was diagnosed with triple-negative breast cancer, a type that can be aggressive and difficult to treat.
After she finished her initial treatment, Karen wanted to learn about all of her options in case the cancer returned. She dived into research, reading medical journals and meeting with doctors and scientists to find out everything she could about therapies for triple-negative breast cancer.
“I wanted a plan of action, and I wanted to make informed decisions based on science,” Karen said. “I felt that when I was first diagnosed I had made decisions based too much on fear.”
In her research, Karen learned about clinical trials — research studies in which people volunteer to have experimental tests or treatments under careful supervision. By participating in a clinical trial, she learned that people may benefit from new treatments that aren’t otherwise available.
Two years later, a CT scan showed the cancer had returned and had spread to Karen’s lungs, ribs, spine, and pelvis. She then asked her oncologist if there were any clinical trials that might be suitable for her. She was disappointed when her oncologist dismissed the idea and instead recommended chemotherapy, the standard treatment. Karen worried that another round of chemotherapy could limit her eligibility for certain clinical trials in the future.
“I had to walk away from my original oncologist at that point because she didn’t value my voice,” Karen said.
She got a second and third opinion from other oncologists who said some of her test results may qualify her for immunotherapy, which uses the body’s immune system to find and destroy cancer cells.
After searching online, Karen found an immunotherapy trial nearby at the Perlmutter Cancer Center at NYU Langone Health. She contacted the trial’s lead researcher, or principal investigator, who, to her surprise, called her right back and told her about another trial studying a combination of two immunotherapy medicines.
Karen was the first person with triple-negative metastatic breast cancer in the United States to enroll in the trial. The principal investigator told her that her chances of responding to the treatment were between 4 and 15 percent.
“I said: ‘I’ll take that chance,’” Karen recalled. “I felt like the trial was custom made for me.”
Eight weeks after she received her first immunotherapy treatment, a CT scan showed the tumors had shrunk by 72 percent. A few months later, the tumors were gone.
“The trial saved my life, plain and simple,” Karen said. “It gave me my life back. I’ve had no evidence of disease since 2019.”
Karen is one of relatively few Black Americans who have had access to state-of-the-art breast cancer treatments through a clinical trial. In fact, she’s only ever met one other Black woman who has. “We are very rare,” she said. “This is not normally our story.”
Why are people of color underrepresented in clinical trials?
In the United States, racial and ethnic minorities have been underrepresented in cancer clinical trials for decades, even when they have a similar or higher risk of the type of cancer being studied.
Black Americans make up more than 13 percent of the U.S. population. But in the clinical trials that led to FDA approval of four new breast cancer treatments in 2020, only 2 to 9 percent of participants were Black. Similarly, Hispanic or Latin Americans make up 18.5 percent of the U.S. population, but accounted for 0 to 9 percent of participants in those same trials.
One of these new treatments is a targeted therapy called Trodelvy (chemical name: sacituzumab govitecan-hziy), used to treat advanced-stage triple-negative breast cancer. Black women are twice as likely as white women to be diagnosed with triple-negative breast cancer in the United States. But only 7 percent of the Trodelvy trial participants were Black.
“It has become increasingly obvious that we in the research community are doing a bad job enrolling people of color in clinical trials,” said Fumiko Chino, M.D., an assistant attending radiation oncologist at Memorial Sloan Kettering Cancer Center in New York City. “This is a problem we can’t ignore. We want clinical trials to find the best treatments for everyone, not just the chosen few.”
The FDA encourages but does not require clinical trials to include diverse participants for new treatments to be approved. The companies, government agencies, and nonprofit organizations that fund clinical trials usually don’t require diversity among participants either.
Also, many clinical trials are partly or entirely conducted in other countries that have a different racial and ethnic makeup than the United States. In the clinical trials that led to FDA approval of 18 new cancer treatments in 2020, 59 percent of participants lived outside of the United States. This is another reason that clinical trials often don’t reflect the diversity of the U.S. population.
Researchers have found that there are some common barriers that prevent people of color from participating in clinical trials. These include:
Not finding out about clinical trial opportunities. Many people of color don’t find out about clinical trial opportunities because their doctors don’t present them as an option. Some doctors may not be knowledgeable about clinical trials. Others may have an unconscious bias that leads them to assume people of color won’t be interested in trials or that they face too many obstacles to participate. This can be a major barrier, because many people don’t know how to ask about, research, or find clinical trials on their own without a doctor’s support.
Overly strict eligibility criteria. Every clinical trial has guidelines about who is eligible to join. These guidelines are called eligibility criteria — or sometimes inclusion or exclusion criteria — and they vary depending on the trial. Factors such as your age, cancer type, cancer stage, other cancer treatments you’ve received, and other health conditions you may have can influence whether you are able to participate in an individual clinical trial.
Eligibility criteria are important. They are meant to protect the safety of trial participants and ensure that they share certain characteristics, such as cancer type or previous treatments. This helps researchers be more certain that the study results are accurate and are not influenced by differences between participants. It also helps researchers make sure that the people being studied are similar to the patients who will eventually receive the treatment if it is approved.
But overly strict eligibility criteria have prevented many people from being able to enroll in clinical trials. Some examples are excluding people who have brain metastases (cancer that has spread to the brain), organ dysfunction, or poor physical function. Others include diseases that disproportionately affect people of color, such as high blood pressure (hypertension), diabetes, HIV, hepatitis B, and hepatitis C. Fortunately, clinical trials are becoming more inclusive in recent years, and researchers are paying closer attention to whether the eligibility criteria for each clinical trial make sense scientifically.
Travel and transportation. Clinical trial participants often have to travel to a clinical trial site for regular in-person visits. These visits are usually done at academic medical centers, which can be quite far depending on where you live. But whether you’re traveling across town or across the country for your clinical trial appointments, it can be time-consuming and expensive. If you lack transportation, can’t take time off from work, or have family caregiving responsibilities, it can be more difficult to participate in a trial.
Out-of-pocket costs. Clinical trials usually pay for anything that is part of the trial, such as the study treatment you’ll receive, while health insurance usually covers routine care costs. But trial participants may have extra, out-of-pocket expenses such as parking, gas, taxis, airfare, and lodging that are not covered by the trial or health insurance. People may also face challenges with insurance coverage during the trial or lost income from time taken off work.
Lack of trust in the healthcare system. Some people don’t trust that clinical trials are conducted in a safe and fair way.
People of color in particular may lack trust in the healthcare system. They may have personally experienced or observed discrimination in a healthcare setting. Or they may have received inferior care; research shows that Black and Hispanic women are less likely than white women to receive breast cancer treatment that adheres to medical guidelines.
“I don’t know one African American person over the age of 35 who hasn’t had at least one bad interaction with a healthcare provider, such as feeling disregarded, not listened to, and being given a premature diagnosis because the provider doesn’t want to pay attention to all their symptoms,” said Marya Shegog, Ph.D., MPH, CHES, health equity and diversity coordinator for the Lazarex Cancer Foundation in Las Vegas, Nevada.
Mistrust in the healthcare system among people of color may also stem from historical events involving highly unethical medical research practices, such as the Tuskegee Syphilis Study and unauthorized use of Henrietta Lacks's cervical cancer cells (known as the HeLa cell line). All of the barriers discussed above contribute to the lack of diversity among clinical trial participants. But the barrier with the biggest impact may be the first one on the list — that people of color simply aren’t being told about clinical trial opportunities or asked to participate.
“If you look at the data on minority participation in clinical trials, it’s not that minorities and underserved populations don’t want to participate, but in a lot of cases they are not aware of their options,” said Eleanor M. Walker, M.D., director of breast radiation oncology for the Henry Ford Health System and medical director of the Henry Ford Health System Center for Integrative Medicine in Detroit, Michigan. “You have to be asked. If it’s not presented to you, how are you going to participate?”
Research shows that, when asked, Black Americans are just as willing or even more willing than other racial and ethnic groups to participate in clinical trials. One study published in 2021 reviewed data from 35 cancer clinical trials and found that 58 percent of Black patients and 55 percent of white patients agreed to enroll when offered the opportunity.
Without being asked and having a doctor’s support, finding a clinical trial and applying to enroll can be a difficult task.
“It’s not an easy process. You can’t go to one online database and come up with all the available breast cancer trials that you could possibly be eligible for. And the information isn’t always at a reading level that is easily understood,” Dr. Shegog said. “Also, your doctor may or may not be able to speak in an informed way about clinical trials.”
Sharon’s story: Finding a trial on her own
Like Karen Peterson, Sharon Rivera-Sanchez discovered that she had to find clinical trials for breast cancer on her own and had to advocate for herself to be included.
After finishing treatment for stage IIb breast cancer in 2016, Sharon was concerned about her risk of recurrence. Treatments that reduce recurrence risk in hormone receptor-positive or HER2-negative breast cancer aren’t effective for triple-negative disease.
“With some other types of breast cancer, you can take a hormonal therapy pill to reduce your risk of the cancer coming back. But with triple-negative breast cancer, we don’t have that,” Sharon said. “I was convinced there had to be something else out there that could help me and other triple-negative breast cancer patients.”
When Sharon asked her medical team about clinical trials, they said they didn’t know of any that were suitable for her. She first heard about a clinical trial she was eligible for on Good Morning America. The trial was looking to see if a blood test could detect recurrence of triple-negative breast cancer earlier than other screening methods, when the cancer is at a more treatable stage.
The trial, however, was being conducted at a site near Los Angeles, California — a long way from Richmond, Virginia, where Sharon lived. To participate in the trial, she was told she would have to make two trips to the trial site in California and could then do her follow-up visits at a site in New York City, closer to home. Still, for those initial trips to California, Sharon would have to pay out-of-pocket for her travel costs, including round-trip airfare, rental car, gas, hotel, and meals.
“It was a challenge financially. It was a hardship. I didn’t have money laying around,” she said.
Sharon’s family raised money through a GoFundMe campaign, and the company where her daughter-in-law works contributed funds to help cover the costs. Still, managing the costs and the logistics of the cross-country travel wasn’t easy, and once she arrived to the California trial site, she was told that she would no longer be able to do her follow-up appointments at the New York City trial site. Traveling to the west coast every 90 days for at least two years was just not possible. She then transferred to a different trial at Penn Medicine's Abramson Cancer Center in Philadelphia, which she found out about from a fellow participant in the first trial.
This new trial is studying a targeted therapy for preventing recurrence in certain people with breast cancer. To participate, Sharon still has to travel (although not as far) and to pay for some of her own travel costs, but she found it to be worth it this time around.
“The entire staff at Abramson Cancer Center are very accommodating, flexible, and appreciative,” she said. “I consider the principal investigator and her team as part of my family.”
These experiences inspired Sharon to advocate for better clinical trial access among people of color and other underrepresented groups who face similar barriers as she did.
Why diversity matters in cancer research
Not being included in clinical trials may be one of the reasons that Black women have worse breast cancer outcomes than other racial and ethnic groups. Black women and white women in the United States get breast cancer at about the same rate, but Black women are 40 percent more likely to die of breast cancer. Black women are also more likely to:
- be diagnosed with breast cancer at younger ages
- be diagnosed with certain aggressive types of breast cancer, such as triple-negative breast cancer and inflammatory breast cancer
- be diagnosed with advanced-stage breast cancer
- have a recurrence of breast cancer
- have delays in diagnosis and treatment
- receive inadequate care
Lack of diversity among clinical trial participants means that new cancer treatments are being tested in groups of people that are not representative of the broader patient population that will receive these treatments if they are approved.
“We need everyone appropriately represented because we want to make sure a therapy works the same way and the side effects are the same in different populations,” said Karen Winkfield, M.D., Ph.D., a radiation oncologist and executive director of the Meharry-Vanderbilt Alliance in Nashville, Tennessee. “We also want to make sure we are providing precision medicine. Sometimes a medicine might work better in one population than another. We need to learn these things up front so we can give each patient the right medicine at the right time.”
Up until recently, women of color have been largely left out of breast cancer research, including treatment trials and other types of studies that help doctors understand risk and risk reduction.
“The majority of research in breast cancer screening, treatment, and hereditary susceptibility has been conducted on women with European ancestry,” said Lisa Newman, M.D., MPH, FACS, FASCO, chief of the Section of Breast Surgery at Weill Cornell Medicine and NewYork-Presbyterian in New York City. “We therefore face major gaps in knowledge. For example, we don’t know whether African American women might benefit from modified breast cancer screening recommendations, and we have an inadequate understanding of the genetics of triple-negative breast cancer.”
Still, it’s important to know that when thinking about the reasons we need to fill in those knowledge gaps, categorizing people by race has a lot of limitations, according to researchers.
“We know that biological, social, and economic factors can impact cancer incidence and outcomes, but the concept of race is tricky. Race is a social construct. At best, race is a surrogate for more complex factors,” said Lori Pierce, M.D., FASTRO, FASCO, professor of radiation oncology and vice provost for academic and faculty affairs at the University of Michigan in Ann Arbor, Michigan, and president of the American Society for Clinical Oncology for 2020-2021.
“The reason we want diverse populations in clinical trials is that we want patients present with a range of genetic, social, economic, and geographic factors. We want all patients to benefit from clinical trials, and, when we assess new therapies, we want to understand how they will impact diverse populations,” Dr. Pierce said.
Saysha’s story: Joining a trial to help others
Joining a clinical trial can benefit you as an individual by giving you access to the newest breast cancer treatments and to the attentive, high quality care that clinical trials can provide.
But it can also be an opportunity to help researchers improve outcomes for other people with breast cancer in the future.
“Participation in a clinical trial is altruistic,” Dr. Chino said. “I can’t guarantee that it will provide additional benefit for you — it may or it may not. But it definitely benefits the next person sitting in your chair.”
The chance to help other Black women undergoing breast cancer treatment in the future is what motivated Saysha Wright to join a clinical trial.
Saysha, a mom of two, was diagnosed with breast cancer in 2019 at the age of 32. When she was about to start chemotherapy, her oncologist at Indiana University Melvin and Bren Simon Cancer Center told her about a new trial that could help address a cancer treatment side effect that disproportionately affects Black women.
Black American women have almost twice the risk as women of other races of developing neuropathy — nerve damage that causes pain, numbness, and loss of sensation in the hands and feet — as a side effect of taxane chemotherapy treatments. If a woman develops severe neuropathy during chemotherapy treatment, it may cause her doctor to lower the dose of chemotherapy or recommend stopping it completely.
The trial is trying to find out which of two commonly prescribed taxane chemotherapy drugs — docetaxel or paclitaxel — is less likely to cause neuropathy in Black women. It’s also trying to see if a blood test for a gene variant can predict who is most at risk for developing neuropathy. The ultimate goal is to help doctors identify ways to reduce the risk of Black women developing neuropathy from chemotherapy for breast cancer.
Saysha agreed to enroll in the trial knowing that it wouldn’t change her treatment; she was already going to receive a taxane chemotherapy. All she had to do was have additional blood tests and answer questions about her symptoms during and after chemotherapy.
“I wanted to help the researchers figure out why African Americans have more neuropathy. That intrigued me,” she said.
Saysha developed a little neuropathy in her thumb and index finger. Unlike for some women, it went away after she finished chemotherapy.
“This research could help prevent some people in the future from losing feeling in their hands and feet for the rest of their lives. Some people never get their feeling back,” Saysha said. “I didn’t have to do much to participate in the trial, but I felt like I was helping out and giving back in some kind of way.”
Improving access to clinical trials
Racial health inequities are receiving new attention, in part because people of color have been disproportionately affected by the COVID-19 pandemic.
Black and Hispanic or Latin Americans have had much higher COVID-19 infection and death rates than whites. Because of this, scientists argued that late-stage clinical trials for the Pfizer and Moderna COVID-19 vaccines should include a higher percentage of people of color than that in the general population. Efforts were made to recruit diverse participants, but in the end only about ten percent of the participants in those trials were Black — less than the percentage of Black Americans in the general population.
“The pandemic really placed a spotlight on the barriers to minority participation in clinical trials,” Dr. Shegog said. “People could see that minorities weren’t being included in the COVID-19 vaccine clinical trials at the rates they were affected by the virus.”
At the same time, the Black Lives Matter movement and the murder of George Floyd and other cases of police brutality made more Americans aware of the ongoing effects of racism.
Now there is a new focus among doctors, researchers, pharmaceutical companies, medical societies, government health agencies, and research institutions on improving access to clinical trials for people of color, noted Dr. Pierce.
“We need all the entities that are involved with clinical trials to come on board, and the moment is right for that,” she said. “More than ever before, people are eager to have meaningful discussions about overcoming the barriers patients face.”
These are a few recent developments that could improve access to clinical trials:
The Clinical Treatment Act: As of January 2022, all state Medicaid programs will be required to cover routine care costs for clinical trial participants on Medicaid who have cancer and other life-threatening conditions. “Routine care” is any cancer care the patient would have received even if they were not in the trial. Medicare and private insurance generally cover these costs, but in the past not all state Medicaid programs did.
Research to understand barriers: Researchers across the United States have partnered with community groups and patient advocates to better understand the factors that prevent people of color from joining clinical trials. Projects launched by Stand Up to Cancer; Penn Medicine Abramson Cancer Center; Henry Ford Cancer Institute; the Duke Clinical & Translational Science Institute and AME Zion HEAL parnership; Breastcancer.org and its partner TOUCH, the Black Breast Cancer Alliance; and others are including the perspectives of people of color in identifying ways to improve access.
Expanding eligibility criteria: As mentioned above, overly strict eligibility criteria have prevented many people from being able to enroll in clinical trials. The FDA, the American Society of Clinical Oncology, the National Cancer Institute, and Friends of Cancer Research have released guidelines encouraging researchers to expand eligibility criteria. Now researchers are carefully considering whether the eligibility rules for each clinical trial are medically and scientifically justified.
New rules in medical journals: Starting in January 2022, the New England Journal of Medicine will require that the research studies it publishes include information on how representative the people in the study are of the broader patient population in terms of race, ethnicity, age, and gender. The goal of this new policy is to encourage researchers to work towards making their studies more inclusive and diverse.
Making clinical trials more convenient: Early in the COVID-19 pandemic, researchers made changes to clinical trials to make it easier and safer for patients to continue participating. A few of these changes will probably stick around long term.
For instance, participants are being offered more virtual appointments through online video — often called telehealth or telemedicine — so they don’t have to travel to the clinical trial site for in-person appointments as often. Also, participants may be given the option of completing the informed consent process virtually rather than in person. This is done by giving verbal consent during a video call, filling out the informed consent paperwork online, and using electronic signatures on the forms.
Ultimately, efforts like these to make clinical trials more patient-friendly and easier to join could benefit all people with cancer.
“If you make it better for one, you’ll make it better for everyone,” Dr. Walker said.
Common challenges (and solutions) to joining a clinical trial
Interested in joining a breast cancer clinical trial, but feeling overwhelmed or don’t know where to start? Here are some common questions about the challenges people face in finding and participating in a clinical trial and some helpful tips on how to find trials and make participating easier.
When is the right time to consider a clinical trial?
You can consider a clinical trial any time you are making a breast cancer treatment decision. Whether you’re newly diagnosed or at another point in your treatment or survivorship, you can ask your doctor or do your own research to find out if you’re eligible for a clinical trial.
Doctors and patient advocates say that every person diagnosed with breast cancer should have a conversation about clinical trials with a knowledgeable healthcare provider as part of their treatment planning process.
A common misconception is that clinical trials are only an option when standard cancer treatments fail. The truth is, there are trials for people with all stages and types of breast cancer.
“Almost anyone affected by breast cancer could be a candidate for a clinical trial,” said Kathy Miller, M.D., professor of oncology and of medicine and associate director of clinical research at the Indiana University Simon Comprehensive Cancer Center in Indianapolis, Indiana. “There are trials looking at prevention and screening strategies, trials looking at treatments for people who are newly diagnosed, and for those who have had previous therapies.”
Depending on your individual situation, a clinical trial may be a good alternative to a standard treatment approach. There are also non-therapeutic trials for people affected by breast cancer that study things such as helping people remember to take their medications or whether yoga improves quality of life.
How do I start the process of looking for a clinical trial?
You may be able to find a trial that is a good fit for you at the medical center where you’re already receiving cancer treatment (especially if it’s a large academic medical center or a community hospital that's affiliated with one). Or you may find that the right trial for you is being done at a different location nearby or even in another part of the country.
To find out if there’s a clinical trial that’s right for you:
Ask your doctors. It’s always a good idea to start by asking your medical oncologist, surgical oncologist, or radiation oncologist if they know of any clinical trials that would be suitable for your unique situation. If your doctors aren’t knowledgeable about clinical trials, ask if they know another doctor they can refer you to who is.
Connect with an expert. You may want to reach out to an expert at a major cancer center that has a lot of clinical trials. You can often set up a telehealth appointment or travel to meet in person with an oncologist at a major cancer center to discuss your options.
Search online. Clinicaltrials.gov is a good place to start when doing your own research on clinical trials that you might be eligible for. You can print out the pages about trials you’re interested in to bring to with you when you meet with your doctors. You can also reach out on your own to the contact person for a trial you’re interested in to ask if you meet the eligibility requirements or for other information. Contact info for the principal investigator or clinical trial coordinator is listed towards the bottom of the page for each trial listed on Clinicaltrials.gov. If a trial has multiple sites that are enrolling patients, you may want to reach out to the principal investigator or clinical trial coordinator at the site closest to you.
Reach out to helpful organizations. The following organizations can help you find clinical trials:
BreastCancerTrials.org has an online matching tool to help you find breast cancer clinical trials that are right for you. The descriptions of the trials are written in patient-friendly language. You can also contact the help desk for assistance in English, Spanish, or Mandarin with finding trials over the phone or by email:
Lazarex Cancer Foundation has patient navigators that can help people with cancer find clinical trial options over the phone or by email:
Susan G. Komen Breast Care Helpline provides information over the phone or by email about breast cancer clinical trials, including assistance with finding a trial, knowing what to expect, and making decisions about trial participation:
Angelmira’s Center for Women with Advanced Cancer helps women with cancer find clinical trials over the phone or by email, in English or Spanish:
What should I expect when applying to enroll in a clinical trial?
If you’re applying to enroll in a clinical trial studying a breast cancer treatment, you’ll typically need to submit your medical records, complete the informed consent process, and then undergo some medical tests (such as blood tests) to make sure you meet the eligibility criteria.
It will save time and make the process of applying easier if you gather all of your medical records in advance and save them on your computer or a flash drive. That way, you’ll be able to share them easily will the clinical trial team. Learn more about gathering and Managing Your Medical Records.
To enroll in a trial, you need to meet the eligibility criteria, which could include factors such as your age, the stage of the cancer, whether you have already had certain other treatments, whether you have a particular inherited gene mutation such as BRCA1 or BRCA2, and whether you have other health conditions. The principal investigator overseeing the clinical trial will decide whether you meet the eligibility criteria. If you don’t meet all the criteria, you can always ask the principal investigator whether or not they can make exceptions so you can enroll in the trial anyway or recommend another trial that may be a better fit.
It may take several weeks before you find out if you are accepted into the trial and can start receiving the study treatment. If you need to change or stop taking any of your current treatments before you start receiving the study treatment, you’ll work with your medical team to do it safely.
Keep in mind that you may need to be persistent to get a response when you contact a clinical trial coordinator or principal investigator for information on a particular clinical trial. If you’re not receiving a response, you may need to make some calls or email other contacts on the clinical trial team or at that medical center until you reach someone who can help.
“The process of selecting patients for clinical trials can be challenging on both ends,” says Sara Hurvitz, M.D., FACP, medical oncologist, professor of medicine, and director of the Breast Cancer Clinical Trials Program in the Division of Hematology-Oncology at the David Geffen School of Medicine at UCLA and medical director for the Clinical Research Unit at the UCLA Jonsson Comprehensive Cancer Center in Santa Monica, California. “If you reach out to the clinical trial coordinator to express your interest in participating in the trial and do not hear back, it's important to be the squeaky wheel to get a response.”
What can I ask of the trial coordinators to make it easier for me to participate in a trial?
When you’re considering enrolling in a trial, ask the clinical trial coordinator about how often you’ll need to come in for in-person appointments and how long you should expect each appointment to take. It also makes sense to ask the clinical trial team and the social worker or patient navigator at the site where the trial will take place about whether any assistance can be provided to make participating easier for you.
“Patients should feel very comfortable saying what their limitations and barriers are,” Dr. Pierce said. “Physicians are getting better at asking the right questions, but we may not be asking about what’s limiting your ability to participate in a trial. A patient should say, ‘I don’t have transportation,’ or ‘I can’t get off from work.’”
Here are some examples of things you could ask that may make participating in a clinical trial easier:
- Is it possible to have fewer in-person appointments?
- Can in-person appointments, bloodwork, or other tests be done at a location that is closer to your home instead of the main trial site?
- Can the informed consent process be done virtually instead of in-person?
- Can medications be sent to your home so you don’t have to get them at the main trial site?
- Can a translator be provided if English is not your first language, and can the clinical trial materials to be sent to you in a language or reading level you can understand?
- Are there parking vouchers and reimbursements for transportation, meals, and other out-of-pocket costs related to traveling to your appointments?
- Can they refer you to an organization or company that provides free or low-cost transportation to appointments? For example, the American Cancer Society’s Road to Recovery program provides rides to and from cancer-related medical appointments for patients who otherwise do not have transportation (although those services may be on hold during the COVID-19 pandemic).
“One of the clinical trials I participated in was very flexible about logistics, and the other one was not,” says Sharon Rivera-Sanchez. “My advice is to ask the trial coordinators how they can be flexible about the trial’s requirements. For instance, maybe you can negotiate going for an appointment once a month instead of every two weeks.”
What costs may be involved with participating in a clinical trial and who can help me navigate the financial and insurance issues?
Before you agree to be part of a clinical trial, talk with the clinical trial coordinator and with your health insurance company so you’ll know what to expect financially.
In most cases, a clinical trial that is studying a cancer treatment won’t pay participants for their time and effort for ethical reasons.
Clinical trial sponsors usually cover the costs of care related to the study. For example, they cover the cost of medicines, procedures, and tests that are part of the study. You and your health insurance plan are expected to cover any “routine care” that is needed during the trial, which means any cancer care you would have received even if they were not in the trial. This can be a gray area, and sometimes patients may have co-pays for things like imaging tests that they thought were part of the trial but wound up getting billed to their insurance.
Typically, a member of the clinical trial team will try to get pre-authorization from your insurance company before you enroll in the trial. If you’re interested in participating in a trial at a medical center that isn’t in your health plan’s network (and you don’t have coverage for out-of-network providers or facilities), your health plan may not cover your routine care during the trial. In any case, you can always try to convince your insurance company to cover your routine care during a trial. It may help to send a letter from your doctor about why the trial is a good fit for you and is medically necessary. And even if your insurance will cover routine care during the trial, ask which insurance-related costs you will wind up being responsible for, such as co-pays, co-insurance, and deductible costs.
If you don’t have health insurance, talk with the social worker, patient navigator, or financial assistance counselor at the medical center where you receive breast cancer treatment. They may be able to help you get coverage and to access resources for financial assistance with out-of-pocket clinical trial costs. If you’re eligible for Medicaid, keep in mind that starting in January 2022, all state Medicaid programs will be required to cover routine care during a clinical trial.
Other costs you might have when traveling to participate in a trial such as gas, parking, tolls, taxis, airfare, meals, and overnight lodging may or may not be reimbursed by the trial. These costs can add up, especially if frequent in-person appointments are required. Always ask which costs the trial coordinators can reimburse you for and whether costs for a caregiver or companion can be reimbursed as well.
If you find the trial isn’t reimbursing you for these costs, you can apply for financial assistance from Lazarex Cancer Foundation. Applicants must be participating in a clinical trial that is studying a cancer therapy at a site in the United States. Income questions and guidelines are part of the application. Lazarex provides need-based financial assistance with transportation (economy airfare, gas, parking, tolls, rental cars) and lodging for the patient and their companion, and with certain medical expenses that are not covered by insurance. You can apply online or over the phone:
A few organizations provide free flights to people who are traveling for cancer treatment or to participate in clinical trials. These include Corporate Angel Network, Miracle Flights, and Air Charity Network.
Another good resource to know about is the American Cancer Society’s Hope Lodge program, which has more than 30 lodges throughout the U.S. and Puerto Rico where cancer patients and their caregivers can potentially stay for free if they are traveling for a clinical trial. Accommodations and eligibility requirements vary by location.
What risks are involved with joining a trial and what safeguards help protect participants?
Enrolling in a clinical trial usually involves some degree of risk. An experimental treatment may have unknown side effects or side effects that are worse than those of standard treatments, and there are no guarantees that it will be effective. In certain types of trials, a participant could be assigned to a group that doesn’t receive the experimental treatment. In most cases, participants receive at least the standard treatment for their condition if they don’t receive the experimental treatment. Placebos (inactive substances or “sugar pills”) are rarely used alone in cancer clinical trials.
During a process called informed consent, the research team explains how the trial will work, the trial’s purpose, and its risks and benefits to the person who is considering enrolling. The purpose of the informed consent process is to help protect participants and make sure they have a full understanding of the trial and their rights before they decide to enroll. A number of other safeguards also help reduce the risk (or potential harm) to participants in clinical trials as much as possible. One of the safeguards is that participants have the right to leave a trial at any time, for any reason.
For more on how clinical trials are conducted, including how randomization, blinding, and placebos may be used, visit our Clinical Trials pages.
How can I find other women who have participated in clinical trials to talk with about their experiences?
You can find other women with breast cancer who have enrolled in clinical trials to speak with through online or in-person breast cancer support groups or by asking your medical team or the social workers at the medical center where you receive treatment if they can connect you with clinical trial participants.
In addition, Karen Peterson has a nonprofit called Karen’s Club and provides free, 30-minute consultations via web video to patients of color who have questions about clinical trials. To schedule a consultation, go to Karensclub.org. Sharon Rivera-Sanchez has a nonprofit called Saving Pennies 4 A Cure and also speaks with patients of color who want to learn more about clinical trials. To contact her, go to Saving Pennies 4 A Cure.
How can I get support and make sure I get my questions answered at my appointments related to enrolling in a clinical trial?
If possible, bring a trusted friend or family member along to in-person or virtual appointments in which you discuss clinical trial participation or consent to participate in a trial. The friend or family member could join by phone or video call if the appointment is virtual or if they otherwise can’t attend in person. They can help by being an extra set of ears, taking notes, asking questions, providing emotional support, or assisting you in making sense of the information.
Darlene Jefferson received radiation treatment for breast cancer in 2017 as part of a clinical trial at the Henry Ford Health System in Detroit, Michigan. She brought her family with her when she discussed enrolling in the trial with her radiation oncologist.
“If you include your family in the meeting with your doctor, they may catch something you would have missed or ask a question you wouldn’t have asked because you’re under too much pressure,” she said. “My family talked with me to see if I wanted to enroll. They encouraged me to do it. They were my rocks and my motivation.”
Written by: Jen Uscher, contributing writer
This Special Report was developed with contributions from the following experts:
Nadine Barrett, Ph.D. MS, MA, medical sociologist, assistant professor of family medicine and community health at Duke University School of Medicine, founding director of the Office of Health Equity and Disparities at the Duke Cancer Institute, director of the Center for Equity in Research within the Duke Clinical and Translational Science Institute, Durham, NC
Carmen Calfa, M.D., breast medical oncologist at the Braman Family Breast Cancer Institute, medical director for the cancer survivorship program, associate director of community outreach, and assistant professor of clinical medicine at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine in Plantation, FL
Fumiko Chino, M.D., assistant attending radiation oncologist at Memorial Sloan Kettering Cancer Center in New York, NY
Susan Colen, program director for BreastCancerTrials.org in San Francisco, CA
Oluwadamilola "Lola" Fayanju, M.D., MA, MPHS, FACS, the Helen O. Dickens Presidential Associate Professor and Chief of Breast Surgery at Penn Medicine, The University of Pennsylvania Health System in Philadelphia, PA
Komal Jhaveri, M.D., FACP, medical oncologist and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center in New York, NY
Sara Hurvitz, M.D., FACP, medical oncologist, professor of medicine, and director of the Breast Cancer Clinical Trials Program in the Division of Hematology-Oncology at the David Geffen School of Medicine at UCLA, and medical director for the Clinical Research Unit at the UCLA Jonsson Comprehensive Cancer Center in Santa Monica, CA
Lisa Newman, M.D., MPH, FACS, FASCO, chief of the Section of Breast Surgery at Weill Cornell Medicine and New York-Presbyterian in New York, NY
Kathy Miller, M.D., Ballvé Lantero Professor of Oncology, and associate director of clinical research at the Indiana University Simon Comprehensive Cancer Center in Indianapolis, IN
Lori Pierce, M.D., FASTRO, FASCO, professor of radiation oncology, vice provost for academic and faculty affairs at the University of Michigan in Ann Arbor, MI, and president of the American Society for Clinical Oncology for 2020-2021
Bryan Schneider, M.D., medical oncologist at IU Health, professor of medicine and medical/molecular genetics, and the Vera Bradley Chair of Oncology at the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis, IN
Marya Shegog, Ph.D., MPH, CHES, Health Equity and Diversity Coordinator for the Lazarex Cancer Foundation in Las Vegas, NV
Jenni Sheng, M.D., assistant professor of oncology, Johns Hopkins University School of Medicine, breast medical oncologist, and research member of GRASP (Guiding Researchers and Advocates to Scientific Partnerships) in Baltimore, MD
Eleanor M. Walker, M.D., director of breast radiation oncology for the Henry Ford Health System and medical director of the Henry Ford Health System Center for Integrative Medicine in Detroit, MI
Marisa Weiss, M.D., cheif medical officer and founder of Breastcancer.org, breast radiation oncologist, director of breast radiation oncology, and director of breast health outreach at Lankenau Medical Center in Wynnewood, PA
Karen Winkfield, M.D., Ph.D., radiation oncologist, executive director of the Meharry-Vanderbilt Alliance in Nashville, TN, former chair of the American Society for Clinical Oncology’s Health Equity Committee
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