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Clinical trials in need of diversity

May 12, 2017

Edith Baker faced a devastating reality that patients with advanced cancer inevitably confront — radiation and chemotherapy could no longer contain her stage four bladder cancer.

But there was a ray of hope. Baker’s oncologist at Saint Francis Hospital and Medical Center referred her to a clinical trial at UConn Health involving two immunotherapy drugs: the Food & Drug Administration-approved Keytruda (pembrolizumab) from Merck & Co., credited with successfully treating former President Jimmy Carter’s melanoma; and Epacadostat (IDO1 inhibitor), an experimental drug from Incyte Corp.

“There was nothing else out there for me,” said Baker, who lives in Plainville. A year later, the retired nurse is living a full life with minimal side effects.

Baker’s outcome is even more extraordinary because she is African American and 81 years old. African Americans and other minorities are at a higher risk for certain types of cancer, yet they continue to be underrepresented in clinical trials for drugs approved by the FDA.

A wide disparity

FDA data released in February show that African Americans made up just 7 percent of clinical trial participants in 2016, up slightly from 5 percent in 2015, for novel drugs. Experts said that depsite a recent federal push toward diversity, the disparity remains wide.

“The fruits of these efforts will be in future years, given that medical product development, on average, can take a decade or longer,” said Dr. Jonca Bull, FDA assistant commissioner for minority health.

For patients, change cannot come soon enough. The latest data from the National Cancer Institute show African American women are more likely to die of breast cancer than white women. In addition, aggressive breast tumors are more common in younger black and Hispanic women; and American Indian and Alaska Natives have higher incidence and death rates for kidney cancer than any other racial/ethnic group.

The underrepresentation cuts across diseases. According to the American Diabetes Association, African Americans are 1.7 times more likely to have diabetes compared to whites. Yet they comprised only 3 percent of the clinical trial participants for Adlyxin (lixisenatide), an injectable drug from Sanofi Pharmaceutical Co. approved by the FDA last year for the treatment of Type 2 diabetes.

To bridge the gap, Congress authorized the FDA to evaluate and address the problem.

“This includes raising awareness of patients about the value of participating in clinical research, ensuring that researchers include clinical scientists who are trusted by minority patients, and that oversight is proactive in addressing enrollment changes at the earliest stages,” Bull said.

As a result, pharmaceutical companies are putting best practices in place to improve participation, and they say they’re seeing results.

Drug companies take action

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, created a cross-cultural leadership team to improve access to clinical trials. The company also is expanding its network of investigators in underserved populations; and is partnering with the Hispanic Federation in New York to create awareness about clinical trials in a culturally relevant way.

“We are seeing improvements in minority participation in clinical trials. However, they are not universal to all trials,” said Nancy Di Dia, chief diversity and inclusion officer for Boehringer Ingelheim. “But we are committed to improving it across the board.”

Pfizer Inc., which has a research facility in Groton, is collaborating with patients to design trials that will work for them, said Pol Vandenbroucke, vice president for medical strategy at Pfizer. For example, the company hired ethnographers to spend time with people with sickle cell disease — an inherited blood disorder that primarily affects African Americans and other minority populations — to “understand their needs and what might fit into their lives, both for trial participation and pain crisis intervention,” Vandenbroucke said.

But some Connecticut researchers say they are struggling to meet diversity enrollment goals.

“We’ve had difficulty recruiting minority populations,” said Dr. Salvatore Del Prete, director of clinical trials at Stamford Hospital’s Bennett Cancer Center. “Some minorities are still reluctant to sign on to a trial not because of access but often because of their cultural beliefs or values.”

These include lingering fears about a well-documented chapter in history when 600 black men in Tuskegee, Ala., were enrolled, without their consent, in a 40-year syphilis experiment by the Public Health Service, beginning in 1932. The men that had the disease were never informed or treated for it, even after penicillin became an effective treatment for syphilis.

Building trust

The breast cancer support group Sisters’ Journey in New Haven is trying to build trust between women of color and the medical community through conversations at hair salons, diaper depots and churches. “When you’re asked (to enroll in a clinical trial) by your hair dresser, your church member, that’s where the trust comes from,” said Dawn White-Bracey, president of Sisters’ Journey. “One of our members said, ‘You may trust your hairdresser more than you trust your doctor.’ ”

The organization in 2015 helped recruit young black women for a five-year clinical trial conducted by Dr. Kristen Zarfos, a breast surgeon at the Hospital of Central Connecticut.

Even though a 1993 law requires all medical research funded by the National Institutes of Health to adequately include minorities, a study by the University of California, San Francisco, found that less than 2 percent succeeded in enrolling enough minority participants.

Dr. Roy Herbst, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, said, “The national average is woefully low,” adding that at Yale, “minorities make up well over 10 percent of the (cancer) clinical trial participants.”

Dr. Mike Lauer, deputy director for extramural research at the NIH, pointed to several successful trials where minorities were well represented. They include a trial by the Sprint Research Group on the effectiveness of standard versus intensive treatment for blood pressure control (31 percent African Americans); and STICH, a study consisting of two trials for the surgical treatment for ischemic heart failure (34 percent minority).

Lauer said the inclusion of women and minorities should start with what is understood about the diseases, meaning that not every study should have the same demographic profile.

“Inclusion extends beyond recruitment and retention,” he said. “It’s also important to consider how findings are reported for specific groups.”

This story was reported under a partnership with the Connecticut Health I-Team ( www.c-hit.org ).

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