A New Look for Clinical Trials
More focused efforts aim to increase the number and type of participants in research studies. One goal is for study participants to be more like the patients who will take the drug if it is approved.
By Sue Rochman
If you wanted to create a playlist of music that would appeal to many different types of people, you probably wouldn’t ask only middle-aged white men in Los Angeles to tell you their favorite songs. More likely, you’d include people of many racial and ethnic backgrounds from all parts of the country: some who grew up with jazz or salsa music, others who were raised on rock ’n’ roll, and still others who know their Bach from their Beethoven.
Cancer treatments are kind of like a playlist: Not everyone responds to them in the same way. To get clinical trial results that will be applicable to the broadest range of people, researchers need to enroll women and men of different ages and racial and ethnic backgrounds in their studies. Yet, when you look at a room of clinical trial participants, you typically see a preponderance of higher-income, middle-aged white men, most of whom don’t have health problems besides their cancer. But what about African-American women with cancer and diabetes? Or elderly Latinos with kidney problems in addition to cancer? Will the treatment be safe or effective for them? If they’re not included in the clinical trial, there is no way to know.
“If you think trials are important, then you have to believe having adequate representation of all populations is important, because that is how we will make sure trial findings are representative and generalizable,” says Susan Eggly, a communication researcher at Wayne State University School of Medicine and Karmanos Cancer Institute in Detroit. It’s also an issue of equal access to health care. “Given that clinical trials are considered the highest-quality care available, it is important to make sure everyone—minorities, women, older people and rural populations—has equal access, and we know right now they don’t,” says Eggly.
Efforts are underway to achieve that goal by increasing the total number of people who enroll in trials, improving outreach to racial and ethnic minorities, and bringing trials to rural communities. Organizations such as the American Society of Clinical Oncology (ASCO) and the Intercultural Cancer Council (ICC) are encouraging researchers to broaden and modify clinical trial eligibility criteria so that a wider range of participants will be eligible for their studies. If these efforts are successful, the result will be clinical trials—and findings—that are more representative of and applicable to all cancer patients who may one day need them.
Getting cancer patients to enroll in clinical trials is not a new problem. In 1990, when he was president-elect of the American Cancer Society, Walter Lawrence Jr. wrote an editorial for CA: A Cancer Journal for Clinicians about the need to increase patient participation in clinical trials. “We were trying to rev up physicians’ interest in getting involved with trials,” recalls the now 92-year-old surgical oncologist emeritus at Virginia Commonwealth University Massey Cancer Center in Richmond. “We also knew most of the public thought being in a clinical trial was like being a guinea pig.”
Nearly three decades ago, “when we were raising hell,” says Lawrence, “fewer than 3 percent of patients were enrolled in clinical trials.” Now, the number hovers around 5 percent. Lawrence says the 2 percentage points demonstrate the progress that has been made. They also point to how much remains to be done.
“We need to get going here,” says Edward S. Kim, a medical oncologist at Carolinas HealthCare System’s Levine Cancer Institute in Charlotte, North Carolina. “The field is moving fast, and we need to move the needle on clinical trial enrollment” so that 25 to 30 percent of cancer patients are enrolled in trials. “We used to think that there were not enough trials,” he says. “That’s not the problem. The problem is that we are excluding people unnecessarily.”
Beyond Big Centers
Exclusion can take many forms. Expanding access to clinical trials beyond large urban areas to smaller cities and rural areas has the potential to both increase enrollment and widen access by overcoming one of the most common barriers—transportation. “It’s not uncommon,” says Eggly, “for someone to not take part in a trial because they can’t get there, they can’t afford parking, or because a friend or family member would need to take time off of work to get them there.”
Hematologist-oncologist Suresh Nair, physician-in-chief of the Lehigh Valley Health Network (LVHN) Cancer Institute in Allentown, Pennsylvania, has been on the front lines of efforts to expand clinical trials beyond major cancer centers. In 2010, LVHN became one of 21 National Cancer Institute (NCI)-selected community cancer centers to offer clinical trials. This helped Nair bring the latest immunotherapy trials to the Lehigh Valley. Nair also worked with pharmaceutical companies to make LVHN one of their immunotherapy trial sites. Trial offerings have continued to grow since August 2015, when LVHN became the second member of the Memorial Sloan Kettering Cancer Center (MSKCC) Alliance, which aims to bring new treatments to cancer patients outside New York City. “With 80 percent of cancer care occurring in the community,” says Nair, “that is where trials need to be.”
LVHN currently has about 200 active clinical trials; about 70 are enrolling new patients. Nair says patients are more likely to say yes to a trial close to home than to one at a large cancer center in Philadelphia or New York City, which can take two hours to get to by car or four hours by bus. “I’ve had patients who I tried to refer to trials turn me down, saying unless they know they’ll be cured, they don’t want to travel that far.”