The emphasis on minority recruitment for clinical trials studies has been a long standing challenge for many years. According to the US National Institute of Health, the reasons for lack of minority participation can be complex and numerous including but is not limited to; many physicians don’t discuss the availability of trials with minority patients; there is a low number of minority investigators (physicians), and there is a lack of information in the community about the potential benefits of participating in clinical trials. Also, at the root of the problem, is the design of clinical trials themselves — the eligibility criteria are very rigid, very standardized, and may exclude patients with many health problems, which is many cases are minorities.
Clinical research is a critical resource for the development of new prevention, diagnosis, and treatment techniques for diseases that affect minorities. Whether one can trust and apply the results of a clinical trial, as well as transfer them into clinical practice, is related to the type and number of patients that are enrolled in the trial. If trials do not include minorities, then there’s a question of whether or not the results of the studies are applicable to everyone across the board. To specifically address this problem, Congress inserted language in the National Institutes of Health (NIH) Revitalization Act which states that NIH clinical research must include ample numbers of minorities, as well as women, in order to allow for in-depth analyses of non-majority U.S. populations.
Now that there is a concentrated effort to increase minority participation, are there adequate measures to retain minority participants during the entire length of the trial? Furthermore, is there an adequate number of trained, qualified researchers and clinical professionals that are able to assess and ask gender/racial/ethnic research related questions that may have a direct impact on the data collected and analyzed in the trial?
It is important to look at the totality of the clinical trial process; oppose to a subset that has been traditionally an obvious challenge; minority participation. For instance, after a minority is successfully and properly enrolled, the community and local health professionals should be keen to not only on human subjects’ protection and current regulations, but also cultural, gender, and social-economic concerns. This is key to; maximize retention of subjects; to delve in deeply potential hidden conditions that the subject may not typical share with healthcare provider(s); and equally important to build a trust factor between subject and investigator (physician).
Inhibiting factor to retain minorities in clinical trials can be quite simple but can be oblivious to professionals not oriented to cultural sensitivities. For example, there can be disconnects between subject and clinical providers through the use of terminology and forms of communications. It has been found that the simple use of the word “clinical program” oppose “clinical study” has proven more successful in the retention of African Americans because the word “study” infers the long-standing cloud of the Tuskegee Study.
[The Tuskegee Study of Untreated Syphilis in the African American Male is the longest non-therapeutic experiment on human beings in medical history, as noted by Arthur L. Caplan (1992). In 1932, the United States Public Health Service conducted a study that purportedly was designed to determine the natural course of untreated latent syphilis in over 400 African American men in Tuskegee, Alabama. The research subjects, all of whom had syphilis when they were enrolled in the study were matched against 200 uninfected subjects who served as a control group. The subjects were recruited with misleading promises of “special free treatment,” which were actually spinal taps done without anesthesia to study the neurological effects of syphilis, and they were enrolled without their informed consent. The subjects received heavy metals therapy and were denied antibiotic therapy when it became clear in the 1940s that penicillin was a safe and effective treatment for the disease. When penicillin became widely available by the early 1950s as the preferred treatment for syphilis, this therapy was again withheld. It wasn’t until 1972, when accounts of the study first was widespread in the news, did the Department of Health, Education and Welfare (HEW) halt the experiment. At that time, 74 of the test subjects were still alive; at least 28, but perhaps more than 100, had died directly from advanced syphilis.]
Age may have a significant impact in retention as well. The older the patient, especially African Americans, there is a highly likelihood they desire to confer with family member(s) before entering and/or staying in a study. Therefore, it is important that the clinical professionals are sensitive and patience during the consenting process and balance the family influences throughout the trial. The clinical research coordinator (CRC) is critical to the process in providing and revalidating study information to the patient throughout the lifecyle of the trial. Surveys show, minorities in general, will ponder the consenting process much longer than a Caucasian subject.
Strategies to maximize minority participant retention rates and enhance the analysis of the efficacy of investigational new drug for minority populations are:
? Working to encourage studies statistically powered to answer gender and racial/ethnic research questions.
? Uphold cultural proficiency as an important factor in clinical research.
? Create partnerships in minority rich populations and create means to conduct clinical studies in that geographic area.
? Create cultural enrichment and awareness campaigns within minority communities. Motivation in trials can’t just be financial in order to help move the negative stereotype about clinical trials out of the communities.
? Provide “VIP” treatment to minority subjects to assure the participation in the study provides a positive environment that encourages retention.
? Over pour information and create a sense of openness, to build trust and understanding for the minority participant.
? Recruit and education more minorities into the field of clinical research for they will be innately keen to cultural, environmental, social/economic backgrounds of diverse subjects.
There has been significant research and campaigns about how to uncover effective ways to recruit minority patients within clinical trials. This effort should forge ahead with great tenacity. However, much attention is needed to retain these precious subjects in the trials and commence dissipating the stigma of the negative effects clinical research has on minority participants.
