Simple Measures Can Encourage African Americans to Join Clinical Trials
African Americans participate in clinical trials far less frequently than do non-Hispanic whites. Mistrust and poor communication are among the barriers persistently identified by health disparities research. However, a program developed at Nashville General Hospital that targets some of these barriers provides 7 years of evidence that recruitment rates can be dramatically increased, according to results presented this week at the AACR annual meeting in Denver.
The hospital is part of Meharry Medical College, the first medical school in the South for African Americans and part of the NCI-funded Minority-Based Community Clinical Oncology Program (MB-CCOP). Meharry participates with the Vanderbilt-Ingram Cancer Center in one of NCI’s comprehensive partnerships, where minority-serving institutions that work primarily in the community setting forge an alliance with a major academic NCI-designated cancer center.
Since the Meharry-Vanderbilt partnership was established in 2000, researchers from the institutions have been developing a systematic model to increase enrollment by African Americans in appropriate cancer clinical trials. “The cornerstone of this approach is to identify eligible patients early, and to earn their trust with effective, honest communication, delivered by trained and permanent staff,” said Dr. Debra Wujcik, director of Meharry’s Cancer Clinical Trials Office.
The study involved 1,125 African American patients newly diagnosed with cancer and screened between 2001 and 2007. While the national average for African American participation in clinical trials is between 2 and 4 percent, the program at Meharry was able to enlist into trials up to 25 percent of all patients who were interviewed.
From 2001 to 2004, 569 patients were screened by the newly trained researchers, who were part of the permanent medical staff and fully integrated into the provision of clinical care. While only 164 were matched to a study, 95 agreed to enroll. This was 17 percent of those screened, but 58 percent of those who were eligible.
After an evaluation of these results, the researchers refined their techniques and began a new dataset in 2005. Through 2007, of 556 patients screened, 80 percent (138 of the 172 patients deemed eligible) agreed to participate in a trial. Combining the two datasets over 7 years, 68 percent of those eligible agreed to participate.
Navigating Cultural Roadblocks
“The program at Meharry proves once again that African Americans are just as willing to participate in trials if the persistent barriers that we know about can be overcome,” said Dr. Harold Freeman, president of the Ralph Lauren Center for Cancer Care and Prevention in New York City and national leader on patient navigation.
“We have to explicitly invite minorities, make them feel welcome, communicate clearly what the research is about in a culturally sensitive manner, earn their trust, and ensure true access” by mitigating such factors as ability to pay and transportation, explained Dr. Freeman, a former director of NCI’s Center to Reduce Cancer Health Disparities. When this happens, he continued, they are just as likely to participate as are non-Hispanic whites.
A Model of Old-fashioned Virtues
Over the course of 7 years, the researchers at Meharry have evolved and refined a culturally sensitive program that Dr. Wujcik believes can be replicated at other community hospitals. However, their success in this case owes much to the partnership with Vanderbilt-Ingram.
Dr. Wujcik explained one practical example. Meharry does not have the radiation facilities that many patients require, so often a patient will receive chemotherapy at Nashville General, and then go to Vanderbilt 4 miles away for radiotherapy. Even though Medicaid can reimburse the cost of transportation, patients who don’t have someone to drive them or the money to take a cab could have their treatment seriously jeopardized.
Nurse navigators who can focus on such details have become an integral part of the clinical trials office system, Dr. Wujcik noted, and a private fund has been established to pay for cab fare when it is needed. It is the lack of “simple services like these that can often have patients falling through the cracks,” she said.
“We also knew that often the clinical trial option is offered as an afterthought, which can lead to mistrust among African Americans if they perceive the research not to be to their benefit,” explained Dr. Wujcik. “We monitor the clinic prospectively. When a patient first learns the results of their biopsy and receives a diagnosis, the list of treatment options already includes any clinical trials they are eligible for.”
Meharry has an established patient navigation program and a patient’s personal circumstances have been woven into this initial meeting. When patients first receive a cancer diagnosis and learn what their prospects might be, the discussion can be difficult, added Dr. Wujcik. Yet it can also provide a crucial opportunity to signal that they can expect trustworthy and personal care.
“The benefits of this partnership clearly run in both directions,” noted Dr. Worta McCaskill-Stevens, who helped design and direct NCI’s MB-CCOP program. “Not only does Meharry effectively expand their resources to include the major academic structure at Vanderbilt, but they also provide a real-world community context for young researchers in training––at both institutions––to appreciate the deeper human side of cancer research.”