RESEARCH THAT REACHES OUT

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RESEARCH THAT REACHES OUT

photo: Roadell Hickman Claudia Potillo is in a clinical trial and has her blood pressure checked regularly

More than 20 years ago, Claudia Potillo began suffering spikes in blood pressure that landed her in the hospital and damaged her kidneys.

"I thought the stress of life was going to take me out," said the 78-year-old Cleveland area woman, who buried her husband and five of her six children because of accidents, illnesses and violence.

But in 2012, a kidney specialist recommended Potillo join a clinical trial whose leaders include Case Western Reserve researchers. They're seeking to determine if lowering blood pressures below standard recommended levels through medication and lifestyle changes can reduce cardiovascular and kidney disease.

Launched in 2010, the nearly decade-long, federally funded, multi-institutional study could be part of a national re-evaluation of optimal blood pressure levels. The research also may help determine whether guidelines should change for people of different races.

Substantial minority participation in medical research is key to understanding the causes of health disparities among races and ethnicities. Research has shown black people suffer in disproportionate numbers from high blood pressure. And they die at higher rates than white people of prostate cancer and other diseases.

"The doctors told me this research could help people like me," said Potillo, who is black.

At Case Western Reserve, researchers and health-care teams visit schools, health fairs, churches and even dance clubs to find minority participants. They've also hired community members to recruit participants, developed more diverse research teams, scheduled clinical trial visits outside work hours and trained medical staffs to make diversity a priority.

Conducting clinical trials with sufficient numbers of diverse populations "is not only the right thing to do, it's better science," said Suzanne Rivera, PhD, the university's vice president for research. "Inclusive research gives us confidence that treatments work in all types of people."

Among the leaders in clinical trial recruitment efforts around the country is Jackson Wright, MD, PhD, a professor in the School of Medicine and director of the Clinical Hypertension Program at University Hospitals (UH) Case Medical Center. He leads a network of 18 research sites in Ohio, New York, Pennsylvania and Louisiana in the ongoing trial that enrolled Potillo.

Wright also has examined what medicines are effective for black populations and put a spotlight on drugs that were less effective. In the mid-1990s, Wright led a national study of more than 42,000 patients, including more than 15,000 patients of African descent. The study showed that new, more expensive blood pressure medications were no better or were less effective in patients of African descent than older, less expensive medications.

Earlier this year, researchers from Case Western Reserve and three other institutions published a study highlighting the discovery of previously unknown DNA segments that, if unique to African-Americans, could help explain why African-American women have a higher risk of pre-menopausal breast cancer compared with other groups. Robert Elston, PhD, Distinguished University Professor and Amasa B. Ford, MD Professor of Geriatric Medicine in the School of Medicine, is among the authors.

And in January, researchers at the Case Comprehensive Cancer Center—a partnership of the university, UH and Cleveland Clinic—announced discoveries from genome sequencing that revealed why black Americans are more likely to develop colon cancer and die more often of the disease.

"We now have genetic proof that colorectal cancer is different in African-Americans at the molecular level," said Sanford Markowitz, MD, PhD, the Dr. Sanford Markowitz/ Frances Wragg Ingalls Professor of Cancer Genetics at the medical school and an oncologist at UH. Markowitz co-led the research as part of a federally funded project focused on gastrointestinal cancers.

Initiatives to Expand Participation

Studies show that African-Americans often are leery of medical research, in part because of concerns they may be harmed in the studies.

The distrust partly stems from the infamous federal Tuskegee syphilis project, in which hundreds of black men with syphilis were followed without treatment, even after it had been demonstrated several years into the study that penicillin was an effective cure. The 40-year study ended in the 1970s and led to major legal changes to protect clinical study participants. But a paucity of minority enrollment prompted a 1993 law mandating the National Institutes of Health to require minority inclusion in all research it funded. Even so, a 2012 federal report found that blacks still are only 5 percent of clinical trial participants and Hispanics 1 percent.

For his part, Wright said he's never had trouble recruiting minorities to his studies.

Wright largely blamed the lack of both data on and enrollment of minorities in many studies elsewhere on the lack of minority investigators. "They are more likely to devote their lives to studying diseases that affect their communities," he said.

To help expand the pipeline of minority students entering science, technology, engineering and math (STEM) fields, Case Western Reserve has partnered with the Association of Underrepresented Minority Fellows (AUMF), an organization of 600 African-American, Hispanic and Native American biomedical scientists. The AUMF has connected undergraduate and graduate students and postdoctoral fellows—about 45 a year—to a national mentoring network of minority STEM researchers.

"When students meet professionals who look like them, and they talk about shared challenges, it becomes personal," said Emmitt Jolly, PhD, an assistant professor of biology at the university and co-founder and president of AUMF. "These critical relationships reinforce student commitment to stay on the path."

For Suchitra Nelson, PhD (GRS '92, epidemiology), a professor of community dentistry in the School of Dental Medicine, part of the success in recruiting and retaining participants for a study of oral health disparities in children was having an outreach staff from the targeted community—in this case, East Cleveland neighborhoods—engaging key stakeholders and building trust. That study yielded a higher-than-average retention rate of minority participants than similar studies. In January, Nelson received a new federal grant to educate parents on oral health as a way to reduce disparities.

And at the Case Comprehensive Cancer Center, a committee charged with boosting minority participation in clinical trials has trained doctors, nurses and staff to become aware of their own biases and better understand different cultures. During the last two years, minority recruitment for cancer center research rose nearly 17 percent.

When Potillo joined her trial, physicians worked with her to develop a plan for medication, food and exercise. Her blood pressure has dropped significantly and her kidney health is improving.

"I feel so good, I told all my friends about it," said Potillo, laughing. "Now they want to join, too."

—Daniel Robison

Jackson Wright, MD, PhD, professor, School of Medicine; director of the Clinical Key Hypertension Program at University Researchers Hospitals (UH) Case Medical Center.

bit.ly/BloodPressureLevelStudy bit.ly/BloodPressureMedicationStudy

Robert Elston, PhD, Distinguished University Professor and Amasa B. Ford, MD Professor of Geriatric Medicine in the School of Medicine.

bit.ly/AABreastCancerStudy

Sanford Markowitz, MD, PhD, the Dr. Sanford Markowitz/Frances Wragg Ingalls Professor of Cancer Genetics at the School of Medicine; an oncologist at UH.

bit.ly/AAColonCancerStudy