Introduction and Background
African Americans comprise 13 percent of the overall population, however, they account for a disproportionate percentage of heart disease, breast cancer, and other health-related problems. Based on the drug trials that have been done on the white populations, the outcomes often prove ineffective for these highly-vulnerable African Americans.
The problems of recruitment into clinical trials are evident among the urban African Americans and based on their numbers they are considered a minority group in the United States. The low interest in and their lack of participation in clinical trials poses a great challenge to the ability to generalize findings as well as to assess how the ongoing researches are useful to the African Americans. Strategies for increasing participation of the “blacks” have been impeded by the paucity of science to offer guidelines for investigators, the model of research, guide for the process of implementation and evaluation of the process of recruitment and tactics of retaining participants. Therefore the low participation of African Africans in clinical trials becomes a high priority.
Corbie-Smith et al (2003) mention several limitations of clinical trials that are due to the poor representation of racial/ethnic minorities against the findings from dominant white populations. These findings cannot be generalized because there is the inability to conduct subgroup analysis, lack of access to high-quality treatment for different, medical conditions, and questionable equity in health services provision.
Major disparities in the healthcare services provision are witnessed occur when ethnic and racial communities are not represented fairly or adequately in medical research. Much broader inclusion of minorities in clinical research and trials is the need of the hour, as per Heiat et al, (2002), as also mandated by the National Institutes of Health Revitalization Act 1993 (NIH p. 103).
Green et al, (2001) believe that, despite the mandate, the inclusion has not been consistent enough to reflect in results that might guide therapeutic decisions. Although the problem has been deemed with greater concern and attention, significant strides are required to advance empirical evidence that can explain the current status quo in clinical research. Proving common misconceptions like racial/ethnic minorities being less inclined to participate in health research than non-Hispanic whites wrong, as done by investigators at the National Institutes of Health (NIH) is a good place to begin from (Wendler et al., 2006).
The article, “Increase Minority Participation and Awareness of Clinical Trials” by The National Medical Association gives some beginning insight into barriers related to participation. Each trial is meant to provide an answer to scientific questions in the pursuit of prevention, screening, diagnosing, or treatment of a disease that meets set standards of the National Medical Association, 2008 (Powell 2008, p. 182). The common reasons why African Americans do not participate in clinical trials are highlighted and include little or lack of awareness, limited access to proper healthcare, recommendation refusals by doctors, personal fear/distrust, cultural beliefs or myths surrounding the research, and discouragement due to the racial and ethnic discrimination (National Medical Association (2008).
Mason (2005, p. 298) categorically mentions that African Americans, as a cultural/racial community, are prone to feelings of uncertainty when participating in clinical trials mainly because of issues of trust with the research community dominated by a Caucasian population. He draws attention to the “Tuskegee Syphilis Study” which is known to be one of the most significantly disgraceful acts in America’s medical research history. Due to the consequences of this study, approximately 400 African American men remained untreated for almost 40 years. This incident has been benchmarked as an instance of abuse and misuse of the research process, making the African American community wary of any research conducted by the dominant population.
Perelman (2001) believes that although controlled clinical trials are widely regarded as the gold stan¬dard in the evaluation of the efficacy of clinical interventions, its external validity is questionable especially if the participants are not representative of the target population. Women, children, the aged and ethnic/racial minorities frequently fall into blanket exclusions (applies equally to every despite other factors), a category in which subjects automatically get excluded (Britton et al.,. 1999)
Though the National Institute of Health demands that minority groups should be adequately represented in medical trials, there has been a continued decrease in the participation of African Americans because of a lack of trust in the trials. This reduced participation greatly affects medical research because it limits the generalizability of information to this minority group and eventually contributes to the desolation of health conditions in the general population (Swanson & Ward 1995, 1747).
As a result, the development of certain drugs or therapies fails to cater to special needs that African Americans may have like genetic influences. Since they are a considerable percentage of the total population, health impact on them is felt by the whole population in terms of pressure on health facilities and spending taxes on their medication. This lack of participation is often associated with the investigators’ difficulties in recruiting and retaining the participants (Shavers-Hornaday et al., 1997).
There are many studies (Linden, et al., 2007, p. 263; Corbie-Smith, 1999) that have indicated that African Americans could be more difficult to convince and recruit into research as they have a lot of barriers to overcome for them to take part in the trial. This, therefore, means that there needs to be a culturally sensitive and appropriate efficient recruitment process (Chandra & Paul, 2003). Such strategies may need to address issues like African Americans’ distrust of the investigators among other barriers like personal physician encouragement and socioeconomic status.
It’s evident that whereas a lot of studies (Chandra & Paul, 2003; Corbie-Smith, 1999; Russell 2008) have been conducted about the low participation of African Americans in medical trials, these studies mostly focus on identifying the barriers. This, therefore, means that there is now adequate information about the barriers to participation which include issues of recruitment and retention (Chandra & Paul, 2003).
However, there is little literature concerning the measures or strategies that can be undertaken to ensure that the participation of African Americans in clinical trials is improved (Swanson & Ward 1995, 1749). There needs to be more information including direct interviews with African Americans on how their participation can be increase. This means that issues that hinder participation or cause opting out hence affecting retention will be incorporated in the study with a questionnaire created to interview African Americans’ fears of participation like trust and expenses as well as the uncertainty of the processes. This study shall focus on bridging this gap.
This study is novel in the aspect of clinical trial participation and it will assess several factors that could affect the participation of African Americans in the research.
It’s imperative to appreciate the feeling of the African American minorities so that the model of recruiting clinical trials in the future would be designed to address the barriers to participation (Chandra & Paul, 2003, p. 38). Their attitudes and beliefs play are a very vital role in influencing their decisions about whether to accept participation or not. It’s as a result essential that researchers understand these factors about African American potential participants. They may readily accept participation if they are invited convivially and actively kept engaged throughout the studies (Chandra & Paul, 2003, p. 38).
Aim & Objectives
The main aim of this dissertation is: To ascertain and assert the specific factors that may help explain the low participation rate of African Americans in clinical trials on Chicago’s Southside.
- To explore the fears or reasons why urban African Americans find it difficult to participate in clinical trials including social aspects like socioeconomic factors (e.g., income, education, values);
- To explore urban African American perception of their low participation in clinical trials and thoughts on future participation;
- To evaluate how discrimination and racism issues influence the participation of urban African Americans in clinical trials.
- To explore ways to improve participation and retention in clinical trials by urban African Americans.
This study will utilize a qualitative research approach. Through the qualitative paradigm, the opportunity is less constrained in exploring the multitude of reasons behind low participation, barriers in recruitment and the extent to which participation can be improved.
Before the research begins, the investigator will seek approval from the Multiple Research Ethics Committee because the study will involve interviews. Besides this, the study will seek approval of all the local research ethics committees that will be involved.
Finally, the investigator before recruitment for this study will seek Institutional Ethical Committee approval from the University of Liverpool.
The focus groups in this study will be recruited on a broad sample base, diverse concerning Chicago’s Southside, gender, age, and economic conditions. Eight to ten participants will make up each of four groups, who will be recruited through nursing homes, clinics and shelters. This will result in a diversity of gender and age and be reflective of the African American general population.
Subject recruitment will take place through face to face meetings at the selected nursing homes, clinics, and shelters that the researcher will book appointments and visit. The participants in the focused groups will be interviewed and selected. Potential participants will be provided with a cover letter that describes the study and the focus group process. Also, potential participants will be asked to complete a brief questionnaire about their attitudes toward the clinical trials medical establishment. Initial skepticism and unwillingness to be a part of medical research are expected but the investigator will explain to potential participants the benefits of the study and assure them of their privacy, informed consent, voluntary participation and, anonymity, voluntary participation and confidentiality.
Focus group meetings will be set up to accommodate participant schedules when possible in private meeting rooms in Chicago’s Southside. Before the start of each group meeting, consent will be provided and obtained from each participant. During the discussion, several key open-ended, non-leading questions will be posted by the moderator (C. Sims, MSc Student). Participants will be asked to respond to questions related to:
- Encounters with medical research and treatment
- The tension between the medical establishment and the African American community
- Trust or distrust of doctors
- Importance of clinical trial to disease diagnosis and subsequent treatment
- Participation or refusal to participate in a clinical trial
- Ways to improve clinical trial participation in the African American community
Strauss’s Grounded Theory will be used to summarize the findings of the focus groups, as it allows the scattered and diverse findings from the field to be coded and compared (Strauss & Corbin, 1994, p. 275). In Grounded Theory, a code is assigned to each issue mentioned during interviews with subjects. This is followed by evaluating consistencies and differences among the codes in the focus groups’ field notes, and then using this information to identify which issues are the most prominent and in what ways they contribute to African Americans’ clinical trial experiences.
The qualitative is meant for such subjects because of the room it makes for the complexities of personal and social experience without divorcing itself from scientific objectivity. The grounded theory, however, helps to pattern the relationship among the abstract categories allocated to the data collected by the investigator in formal statements and theories. In other instances, relationships and patterns can be assessed based on other specific hypothetical points of view.
This research aims to understand the current thoughts and perceptions of urban African Americans related to clinical trial participation. This is critical in being able to suggest ways to reduce barriers that urban African Americans encounter and to facilitate prospective research in the urban African American community.
The cost of conducting each focus group will be an estimate of gas $20, refreshments $50 and office supplies $30 totaling to $100 per group session.
Research has to be divided into different parts, starting from:
|March to September||Proposal Development||Included is a complete overview which will give the reader(s) a clear perception of my dissertation. During the methodology selection of my dissertation topic, I will include my expertise and knowledge to ensure that the dissertation is original. During the literature review stage of my dissertation, I would complete a comprehensive literature review of the topic.|
|October||IEC submission and approval||The proposal will be handed over to the IEC so that it can be read through and the research data collection authorized.|
|November to December||Recruitment of Focus group||The members of the focus groups are to be carefully selected preferably through an interview to ensure the data is well collected.|
|January to February||Data analysis||Analyze the data using thematic analysis. I will develop a codebook based on the participant’s responses and use it as a guide to organizing all the transcribed data.|
|March to April||Recommendations||Based on the study findings, I will propose several recommendations intended to improve African American participation in clinical trials on Chicago’s Southside. Thereafter, I will compile complete my dissertation.|
|Conclusion||1 week||My dissertation will be completed before the submission due date. Before this, I will make any revisions needed.|
Adams-Campbell, LL., Ahaghotu, C., Gaskins, M., et al., 2004, ‘Enrollment of African Americans onto clinical treatment trials: study design barriers,’ J Clin Oncol, 22 (4): 730–4.
Britton, A., McKee, M., Black, N., McPherson, K., Sanderson, C., & Bain, C. 1999. Threats To Applicability Of Randomized Trials: Exclusions And Selective Participation. Journal Of Health Services, Research, And Policy, 4(2), 112-21.
Chandra, A & Paul, DP 2003, ‘African American Participation In Clinical Trials: Recruitment Difficulties And Potential Remedies’, Hosp Top 3; 81: 33-8.
Corbie-Smith, G., 1999, ‘Attitude And Beliefs Of African Americans Towards Participation In Medical Research,’ Journal Of General Internal Medicine, 14, (1999): 537–546.
Corbie-Smith, G., et al., 2003, ‘Trust, Benefit, Satisfaction, And Burden: A Randomized Controlled Trial To Reduce Cancer Risk Through African-American Churches,’ J Gen Intern Med, 18 (7):531–41.
Green, BL., et al., 2000, ‘African Americans Attitudes Regarding Cancer Clinical Trials And Research Studies—Results From Focus Group Methodology,’ Ethn Dis 10(1):76–86.
Heiat, A., Gross, CP., & Krumholz, HM., 2002, ‘Representation Of The Elderly, Women, And Minorities In Heart Failure Clinical Trials,’ Arch Intern Med 162:1682–8.
Herring, P., Montgomery, S., Yancey, AK., Williams, D., Fraser, G., 2004, ‘Understanding The Challenges In Recruiting African Americans To A Longitudinal Cohort Study: The Adventist Health Study,’ Ethn Dis 2004;14(3):423–30.
Linden, H et al., 2007, ‘Attitudes Towards Participation In Breast Cancer Randomised Clinical Trials In The African American Community: A Focus Group Study,’ J Cancer Nursing, 30, 261-269.
Linden, H., et al., 2007, “Attitudes Towards Participation In Breast Cancer Randomized Clinical trials In The African American Community: A Focus Group Study,” Cancer Nursing, 30, 261-269.
Mason, SE., 2005, Offering Africans Americans Opportunities To Participate In Clinical Trials Research: How Social Workers Can Help, Health Soc Work, 30:296-304.
National Institutes of Health (NIH) Revitalization Act of 1993, Public Law 103-143.
Ness, RB., Nelson, DB., Kumanyika, SK., Griss, JA., 1997, ‘Evaluating Minority Recruitment Into Clinical Studies: How Good Are The Data?’ Ann Epidemiol 7(7):472–8.
Perelman, AM., 2001, ‘The Impact Of The New Sexual Pharmaceuticals On Sex Therapy, Current Psychiatry Reports, Vol. 3, No. 3, Pp. 195 – 201.
Powell, J., 2008, ‘Project IMPACT – Increase Minority Participation And Awareness Of Clinical Trials, The National Medical Association Project,’ J Natl Med Assoc, 100(2):178-87.
Russell, K., et al., 2008, ‘Barriers To Recruiting Urban African American Women Into Research Studies In Community Settings,’ Applied Nursing Research, Vol. 21, Issue 2, pp. 90-97.
Shavers-Hornaday, VL., Lynch, CF., Burmeister, LF., & Torner, JC 1997, ‘Why African Americans Are Underrepresented in Medical Research Studies? Impediments To Participation’, Ethn Health; 2: 31-45.
Strauss, A., & Corbin, J., 1994, Grounded Theory Methodology: An Overview. In: Denzin, N., And Lincoln, Y., Eds. Handbook Of Qualitative Research. Thousand Oaks, CA: Sage Publications. Pp. 273-285.
Swanson, GM, & Ward, AJ., 1995, ‘Recruiting Minorities Into Clinical Trials: Toward A Participant-Friendly System’, J Matl Cancer Inst, 87: 1747–59.
Wendler, D., Kington, R., Madans J, et al., 2006, ‘Are Racial And Ethnic Minorities Less Willing To Participate In Health Research?’ PLoS Med 3(6): E19.