Less than 10 percent of people with cancer in the United States participate in clinical trials. Here are some reasons why.

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Experts say participation by people of color in clinical cancer trials is low because of distrust, access, and other factors. Getty Images

When Susan Gubar received a diagnosis of ovarian cancer for the third time in 2012, she was given the option of going through her third regimen of chemotherapy in four years.

But chemo wasn’t producing the results she wanted. So, instead, she chose to enroll in a clinical trial.

Gubar, 74, an author and professor emerita of English and women’s studies at Indiana University, was treated with a targeted new cancer treatment called talazoparib.

An oral medication, talazoparib inhibits the PARP protein in cancer cells that’s responsible for repairing damaged DNA. Without repair, tumor cells will die, but healthy cells are spared.

The treatment gave Gubar a complete remission. And she remains cancer-free.

“I’m still on the trial. I take four pills a day. I have very little hair, I wear a wig, and I have fatigue, but it doesn’t make me sick,” said Gubar, who’s become an advocate for her fellow cancer patients and staunch proponent of clinical trials.

“I believe clinical trials should be an option for patients even when you are at the beginning of treatment, not just when your cancer recurs,” she told Healthline.

“But that is rough, because a cancer diagnosis is traumatic. As a patient, you are freaked out. But clinical trials give you options, and many of them are free. Many people don’t know this,” she said.

Clinical trials are studies of treatments not yet approved by the Food and Drug Administration (FDA) that seek to answer specific health questions, including the safety and effectiveness of these treatments in humans.

Cancer patients gained 3.34 million years of life thanks to clinical trials run by SWOG, the global cancer research community that conducts clinical trials and is supported by the National Cancer Institute (NCI).

In recent years, there have been a number of new cancer treatments, including the emergence of immunotherapies, targeted therapies, gene therapies, and other new modalities.

However, only a small percentage of cancer patients actually enroll in trials.

A recent meta-analysis by Dr. Joseph Unger at the Fred Hutchinson Cancer Research Center in Seattle, Washington, reveals that only 8 percent of adult cancer patients in the United States choose to enter a clinical trial.

Why do so few patients participate?

One major reason is that there are still many misconceptions about clinical trials.

Experts tell Healthline that many people still think trials are expensive and only available to wealthy patients. They also believe the trials aren’t safe, that they might give participants a placebo and not any treatment at all, and that trials are only for those who have no other treatment options.

None of this is true.

But Unger as well as several clinical trial experts interviewed for this story agree that the biggest problem with clinical trials are barriers that have nothing to do with a person’s willingness to enroll.

“From the beginning of a patient’s cancer evaluation, from the moment they walk into the clinic, there are multiple barriers to participating in a clinical trial,” Unger explained in a press release.

“It turns out structural barriers alone — the fact that there’s just not a trial available — represent the reason why more than half of patients don’t go on trials,” he said.

For this study, Unger, along with Columbia University Irving Medical Center and the American Cancer Society Cancer Action Network (ACS CAN), reviewed 13 studies — nine in academic and four in community settings — with nearly 9,000 participants.

His findings emphasize the “enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients,” Unger wrote.

More than half of those in the studies didn’t participate in a trial simply because no trial was available for their type and/or stage of cancer at their center.

An additional 21 percent were ineligible for whatever trials were available because of clinical barriers.

Physician-related and patient-related barriers, such as not being asked to participate or refusing to participate, made up the remaining 23 percent.

The American Cancer Society Cancer Action Network (ACS CAN) is recommending big changes in the eligibility criteria for cancer clinical trials.

Mark Fleury, PhD, MS, a policy principal and emerging science researcher at ACS CAN who co-authored the Unger study, told Healthline that expanding trial locations, updating eligibility criteria, and encouraging physicians to discuss clinical trial options with their patients will increase enrollment.

Over half of cancer patients don’t have a trial at their site for their cancer. That is huge,” Fleury said.

“Oftentimes, if the patient only understood how important it is, they would do the trial. Most patients are interested, but most aren’t asked or have a trial available to them,” he said.

Fleury added that for people who are at cancer centers without clinical research or trials, “We need to better understand what factors would promote their providers referring them to nearby centers that do have trials.”

Fleury says ACS CAN is implementing a survey in the field later this fall at small, community health providers to explore this issue more deeply.

“As a result, these centers indeed might lose that patient. That is part of what we want to understand,” he said.

Fleury adds there’s a combination of reasons why small sites may not screen and refer the larger clinical trial site to a patient, including loss of income.

However, Fluery said, “About 80 percent of all cancer patients who end up in clinical trials found out about it through their provider or someone from the study. Their cancer provider told them about it or someone from the study contacted them.”

Another reason why there aren’t more people enrolling in clinical trials is the reluctance some members of ethnic populations feel about healthcare in general and also about reporting personal information to any agency.

For example, while 18 percent of the U.S. population is Hispanic, only 1 percent enroll in trials.

In addition, while 13 percent of the U.S. population is African American, only 5 percent enroll in clinical trials.

And less than 5 percent of African American patients were included in trials for 24 of the 31 cancer drugs approved since 2015, according to a report from ProPublica.

In March 2019, Johnaya Poindexter, 22, an African American woman from Chester, Pennsylvania, received a diagnosis of Hodgkin’s lymphoma.

While giving Poindexter diagnostic tests to learn more about her cancer, her doctors at Sidney Kimmel Cancer Center–Jefferson Health in Philadelphia discovered that she qualified for a clinical trial for people with Epstein-Barr virus–associated lymphoma.

The virus is in 90 percent of adults and typically remains dormant. But it can cause various types of lymphoma, both B cell and T cell.

Poindexter’s doctors gave her the option of enrolling in a stage IB/II clinical trial of nanatinostat, an oral histone deacetylase (HDAC) inhibitor that works in combination with valganciclovir, an antiviral medication to treat people with a wide variety of EBV-associated lymphomas, both non-Hodgkin’s and Hodgkin’s.

Poindexter, who was working as a medical assistant but had to leave her job because of her illness, agreed to enroll in the trial.

It’s been slightly more than two months since Poindexter began the trial, and she’s already in remission, according to Pierluigi Porcu, an oncologist who heads the blood cancer and stem cell transplant division at the Sidney Kimmel Cancer Center–Jefferson Health and the lead investigator on Poindexter’s trial.

Poindexter says she wants people with cancer to know that trials are a good option to consider.

“Don’t be afraid to try it. It is helping me, and I think it could help you,” she told Healthline. “I was really afraid to try it, but I am only three months in on the trial and it is working.”

Poindexter says her doctors made sure she clearly understood what the trial was all about.

“I wasn’t blindsided or anything. The doctors had my best interests in mind,” she said.

Porcu says Poindexter is a perfect example of the kind of person who should enroll in a trial but rarely does.

“Almost all cancer drugs that patients are using and benefiting from today were developed thanks to clinical trials,” he told Healthline. “Simply said, without clinical trials, there would be no progress in cancer care.”

Porcu suggests that clinical trials are essential not only because they provide information on the safety and efficacy of new cancer drugs, but also because the quality of the data that’s collected is vastly better than that outside of clinical trials.

“This is because clinical trials are run prospectively and the data is collected in a controlled way,” he said. “Clinical trials are also the best way to shed light on and bring greater public attention to cancer types that are neglected or understudied, such as EBV-associated lymphomas.”

But distrust within some communities is a lingering issue.

Many African Americans, for example, still remember the horrors of the Tuskegee experiment, in which syphilis treatment was withheld from a group of African American men for many years.

However, trial advocates note that federal guidelines and codes of ethics are in place now to protect clinical research volunteers from harm.

Cancer centers nationwide are aware of the disparities. Many of them are boosting efforts and initiating new programs to make clinical trials available to the entire population, not just a select few.

At the UC San Diego Moores Cancer Center, officials have implemented an effort to connect with various ethnic communities in San Diego County to make sure they’re aware of their clinical trial options.

Sandip Patel, an oncologist, cancer researcher, and assistant professor of medicine at Moores Cancer Center, says his new role as clinical trials office liaison to the community has given him a welcome opportunity to reach out to populations that aren’t always served.

“Language and culture can be enormous barriers to patients who may want to enroll in a clinical trial,” Patel told Healthline. “Clinical trial enrollment rates are not as high as they should be in these communities, but we are working to change that.”

Patel notes that reporting issues are difficult in some of these communities.

“Even within the San Diego County, the types of cancer you fight in clinic in one part of the county, such as La Jolla, are different than the ones you fight in Oceanside. We see a higher percentage of liver cancer in the Asian population, for example, and in the Hispanic community, breast cancer issues are significant,” he said.

Reporting cancer trends and issues are difficult, Patel says, in part because of the lack of trust some communities have in reporting personal information to any agency or entity.

Hispanic Americans have a higher likelihood of radon exposure, for example. Because of that, they’re more likely to receive lung cancer diagnoses, Patel says. But many are still reluctant to report this information.

“The recent talk of adding a citizenship question to the census, for example, and the ICE raids, things like that, make people afraid to report anything, including health-related issues, and it has an impact on cancer trials,” Patel said. “We are a border town, we speak multiple languages. We are a bi-national community.”

Another reason many patients can’t enroll in a clinical trial is that federal law doesn’t require Medicaid to cover the routine costs of participating.

Only 12 states require this coverage — leaving 42 million people on Medicaid in 38 states potentially without clinical trial coverage, according to the American Society of Clinical Oncology (ASCO).

All other major healthcare players, including Medicare, cover these costs.

The Clinical Treatment Act (H.R. 913), a bill introduced by Rep. Gus Bilirakis (R-FL) and Ben Ray Lujan (D-NM), would guarantee coverage of the routine care costs of participation in an approved clinical trial for Medicaid enrollees with a life-threatening condition.

Proponents of the legislation say it would give clinical trial access to millions more Americans, including people with disabilities, children, and those living in rural areas.

Medicare has covered clinical trial access since a 2000 national coverage decision. Private payers are required to provide coverage under the provisions of the Public Health Service Act section 2709.

This was enacted as part of the Affordable Care Act.

For low-income families who don’t have access to the internet, don’t speak fluent English, or both, cancer centers are increasing their efforts to reach out to them by hiring bilingual liaisons and printing clinical trial packets in multiple languages.

Another relatively new trend in the clinical trial space are patient navigators who can help guide people to the right trials and walk them through the process.

These navigators can be independent, part of the cancer hospital, attached to a specific clinical trial, or work for a pharmaceutical company.

There are multiple resources available online now for anyone who’s interested in seeking and finding a clinical trial.

The list of online resources for clinical trial participants, which are compiled by ASCO, are lengthy. They start with the National Cancer Institute website.

In addition, the site ClinicalTrials.gov lists publicly and privately supported clinical trials.

The National Library of Medicine at the National Institutes of Health (NIH) maintains the website, which provides information on thousands of studies. The research addresses various diseases and conditions, including cancer. Studies take place in all 50 states and multiple countries.

There are more resources online now for people seeking information on new treatments and trials. The following organizations offer free, searchable listings of cancer clinical trials:

  • Center for Information and Study on Clinical Research Participation (CISCRP): The staff at CISCRP conduct free clinical trial searches. To request their help, complete the online form. You’ll receive potential research study matches.
  • CenterWatch provides information on clinical trials. It includes a database with thousands of open clinical trials.
  • EmergingMed identifies clinical trial options. These options are based on a person’s diagnosis, stage, and treatment history. Upon request, clinical trial specialists provide telephone support.
  • Lazarex Cancer Foundation helps people find clinical trials and financial assistance. Request help through the organization’s online contact form or by phone.
  • National Cancer Institute (NCI): This federal agency provides funding for most U.S. cancer clinical trials. The site lists open and closed cancer clinical trials sponsored or supported by NCI. Find NCI-supported clinical trials with the search tool.
  • TAPUR Study: Conducted by ASCO, this trial studies advanced cancer in adults. It explores whether specific targeted therapies may benefit more patients. Learn more through Cancer.net’s TAPUR Study summary.
  • World Health Organization (WHO) International Clinical Trials Registry Platform: WHO coordinates health matters within the United Nations. Their search portal gathers clinical trial information from many countries’ registries.

You can also contact individual medical centers and cancer centers, pharmaceutical companies, patient advocacy organizations, or individual patient advocates.

The following organizations provide cancer type-specific clinical trial listings and other study opportunities:

  • BreastCancerTrials.org helps users find breast cancer-specific clinical trials. It includes a separate search engine for metastatic breast cancer trials. Its alert service notifies users of recently added clinical trials.
  • Melanoma Research Alliance suggests melanoma clinical trials based on your answers to a series of questions.
  • Metastatic Prostate Cancer Project (MPCproject): The MPCproject gathers information on advanced and metastatic prostate cancer. The findings will help researchers study new treatment options.
  • National Brain Tumor Society has a database people can search for brain tumor-specific clinical trials.
  • Pancreatic Cancer Action Network Clinical Trial Finder allows people to search for pancreatic cancer-specific clinical trials.
  • SPOHNC Clinical Trial Navigation Service: Support for People with Oral and Head and Neck Cancer (SPOHNC) provides this resource, which helps people find diagnosis-specific clinical trials. People can access information through an online search tool. Or they may call to speak with a clinical trial navigator.
  • The Leukemia & Lymphoma Society Clinical Trial Support Center helps people with leukemia, lymphoma, or myeloma. People connect with support specialists by phone, live chat, or email. Specialists provide a personalized list of relevant clinical trials.
  • Us TOO Prostate Cancer Clinical Trial Finder offers information on prostate cancer-specific clinical trials. People access the information online or over the phone.

And finally, you can watch videos on PRE-ACT (Preparatory Education About Clinical Trials), an educational program designed to provide general information about clinical trials with support from the NCI to help patients better understand what clinical trials are and how they work.

Jamie Reno is an award-winning journalist, author, global advocate for cancer patients, and three-time, 22-year survivor of stage 4 non-Hodgkin’s lymphoma. He is alive today because he enrolled in a clinical trial 20 years ago.