Reaching Out
by Adam Istas
March 2007
In order to recruit a more ethnically diverse pool of patients, investigators and clinical trial coordinators are seeking buy-in from community leaders.
The success of any clinical development program largely depends upon recruiting and retaining the right patients. As targeted therapies and personalized medicine become more commonplace, enrolling a specific group of patients—by condition, genotype or ethnicity—requires targeted strategies that go beyond traditional recruiting models. Investigators and trial coordinators are learning that thorough knowledge of the target community is a critical component of a successful trial.
Spreading the Word
Achieving clinical trial participation from ethnic minorities requires more than a savvy marketing campaign and a targeted message. “You have to go after the community gatekeepers, and they’re not in the places you think they are,” says Dorothy Edwards, Ph.D., associate professor of occupational therapy and neurology at Washington University School of Medicine, in St. Louis, Mo., USA.
As part of her work with the African American Outreach Satellite program of the Washington University Alzheimer’s Disease Research Center, Edwards has spent more than 15 years educating community leaders in churches, retirement centers, health fairs and even beauty salons. She advocates presenting trial information to the community in a way that is both understandable and meaningful for the prospective study subjects. “You need to explain how the specific condition being studied is more prevalent in their community and among their ethnicity, and assure them that you are trying to help,” she says. The most important thing is to assure the community that the researchers are in it for the long haul. “We have to demonstrate a commitment to addressing the underlying health condition in the targeted population,” she says.
Clinical trial sponsors must take this specific type of recruiting into account when planning a clinical trial, Edwards says. Strategies such as distributing newsletters about a trial to participants, publishing trial results in plain language in community newspapers, and hiring the research team from the community of interest all help to build trust and will increase the chances for recruiting success, she says. “Little things like subject compensation and transportation also go a long way,” she says. “It’s big commitment on the patient’s part to enroll in a clinical trial; we need to make it easier for them.”
Conducting a study with minority participants requires more effort to overcome the barriers to recruitment, says Dr. Philip Gorelick, director of the center for stroke research and head of the department of neurology and rehabilitation at the University of Illinois College of Medicine, in Chicago, Ill., USA. Gorelick was the principal investigator of the African American Antiplatelet Stroke Prevention Study (AAASPS), the first large-scale recurrent stroke study of African Americans. Recruitment barriers in the African American community include a general distrust of the medical system, social isolation and a lack of communication to the minority community about clinical research, he says.
In acknowledgment of these factors, Gorelick and his colleagues prepared a recruiting strategy before they launched the AAASPS. “We developed in-depth training programs for local site staff,” Gorelick says. The AAASPS researchers also provided cultural sensitivity training for study workers, produced training tapes and conducted community research to learn about traditional health care in the African American community, he says. “Community buy-in before the study was launched was a key factor,” Gorelick says.
The Recruitment Triangle
The AAASPS researchers identified what they call a “recruitment triangle,” which consists of the patient, the patient’s family and the patient’s doctor. All three groups must be knowledgeable about the study and support the potential patient throughout the life of the trial, Gorelick says. If one or more of these groups is not fully supportive, the patient is not likely to enroll or remain in the study, he says.
In order to develop the patient’s and family’s trust, trial sponsors must take time to research the community of interest. “To be successful, one must have an in-depth understanding of the customs and culture of the ethnically diverse community, be willing to spend a bit more time in the recruitment and retention process, and maintain strict confidentiality and honesty about the study,” Gorelick says.
Achieving recruiting success in one trial also can lead to success in future studies. “Every time a patient has a positive experience in a clinical trial,” Edwards says, “there’s a greater chance that the patient will enroll in another one, and then spread the word to their friends and family.”
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