Project I.M.P.A.C.T. works to include minorities in trials
|Attendees interested in Project I.M.P.A.C.T. attended a workshop on minority trials Monday.
Minorities have been historically underrepresented in clinical trials, something that Project I.M.P.A.C.T. (Increase Minority Participation and Awareness of Clinical Trials) seeks to fix. A 1999 NMA Consensus Panel concluded that under-representation of minorities in clinical trials helps contribute to health disparities.
Monday's Project I.M.P.A.C.T. session discussed ways to increase clinical trial participation by minority patients and minority investigators.
"Clinical trials are critical to our understanding and use of drugs and devices," said Kwame Osei, M.D., professor at The Ohio State University Medical Center's Diabetes Research Center. The inclusion of minorities in these trials improves the overall clinical picture of the disease and who it affects. Clinical trials can also deal with economic issues related to illness and health care disparities.
"Diseases don't live in isolation. They live in societies."
Recruiting African-Americans and other minorities takes a special effort. After years of mistreatment by the medical establishment, many are understandably hesitant to participate in medical research. The presence of a minority investigator can help reassure patients, Dr. Osei said. Limited numbers of minority investigators and a non-diverse staff can thus hinder the recruitment of minority study participants.
Effective advertising strategies can also help with minority recruitment. Formal advertisements of trials can appear on radio and TV, as well as in newspapers and public areas. Informal advertising in barber shops, salons, and churches can also help recruit interested participants.
These advertisements are "good for producing awareness of the study, but for blacks in particular, personal contact is the most effective way of getting patients into the study," said Jackson Wright, M.D., a professor in the Division of Nephrology and Hypertension at Case Western Reserve University in Cleveland.
Chart reviews and searches of electronic medical records, and financial databases with ICD codes can also be a good way of recruiting clinical trial participants. Physicians already have relationships with their patients, and can often do baseline screening as part of normal standard of care. This existing relationship can encourage patients to enroll in clinical trials.
Dr. Wright also noted that http://researchmatch.org
, a national website of the NIH, can match interested participants with relevant clinical trials. "I have been impressed by the yield, including blacks, recruited into my studies" via Researchmatch, he said.
Although some people do participate in clinical studies for financial compensation provided to study members, it's relatively rare. "The vast majority don't have a financial motive. They do so for altruistic reasons, as well as the care and attention they receive that they get nowhere else," Dr. Wright said.
Once all patients have been recruited into a clinical trial, researchers must begin the task of keeping their study participants enrolled for the duration of the trial. He said that investigators need to address potential barriers for clinical trial retention with participants early in the trial. Often, simple efforts to make study participation easier, such as reimbursement for travel costs, and bus or taxi vouchers, can make a big difference.
Retaining good clinical staff also helps participants remain enrolled in clinical trials. Participants generally have the most contact with office staff, and these bonds can give patients added incentive to continue showing up at their appointments.
Even the best-run clinical trials don't always have the desired outcome, Dr. Osei said. If investigators knew the trial's outcomes ahead of time, there would be no reason to have a trial. This is why it's important to keep patients apprised of potential risks throughout the study.
The formal conclusion of a trial doesn't mean that the effects of the treatment have concluded. Treatment benefits may not become apparent until years after the actual trial. This legacy effect makes post-trial follow-up so important.
It may also help translate the results of the trial into effective clinical practice. Most clinical trial participants, said Dr. Osei, aren't "real-world patients." They're generally carefully selected to exclude those with complicated comorbidities. Everyday patients aren't screened and outcome data may need to be tailored to fit their particular needs.
Data from one study often raises new questions that can only be answered by another study. "Clinical trials beget clinical trials," he said, adding that including minorities in more clinical trials will have an effect that can ripple through the medical community.