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 Caucasian populations, the outcomes often prove ineffective for the highly vulnerable African American category.
The problems of clinical trial recruitment are evident among urban African Americans, and based on the numbers they are considered a minority group in the United States. Their lack of participation and low interest in clinical trials poses a great challenge in generalizing findings, as well as assessing how ongoing research can be useful to this population. Strategies for increasing participation of the “blacks” have been impeded by the paucity of science to offer guidelines for investigators. If available, this model of research could guide the implementation and evaluation of recruitment and tactics for retaining participants. Therefore, an investigation of the low participation of African Africans in clinical trials is a priority.
Corbie-Smith et al (2003) mentions that a number of limitations of clinical trials are due to poor representation of racial/ethnic minorities, compared to the findings from predominantly white populations. These findings cannot be generalized because there is inability to conduct subgroup analyses, lack of access to high quality treatment for different medical conditions, and questionable equity in health services provision. Major disparities in healthcare service provisions occur when ethnic and racial communities are not represented fairly or adequately in medical research. A much broader inclusion of minorities in clinical research trials is needed, as per Heiat et al, (2002), and 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 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 such as 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 for 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 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 a period of 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 standard 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 the African Americans because of 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, developments of certain drugs or therapies fail to cater for special needs that African Americans may have like genetic influences. Since they are a considerable percentage of the total population, health impacts affect 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 of 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 a 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.
Studies (Chandra & Paul, 2003; Corbie-Smith, 1999; Russell 2008) have been conducted on the low participation of African American in medical trials, mostly focusing on identifying the barriers. This means that there is fairly adequate background information about the barriers to participation for some regions, and this information includes issues of recruitment and retention (Chandra & Paul, 2003). However, an exploration of the barriers to include issues of recruitment and retention has not been undertaken in many urban areas of the United States, such as the one being proposed in this study. In addition, while some studies have focused on the barriers, the root cause has not been set yet. Therefore, 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 the African American on how their participation can be increase. I hope to gather this information from the questionnaires. This means that factors hindering participation or affecting retention will be incorporated in the study questionnaires created to interview Chicago’s Southside African American fears of participation like trust and expenses as well as 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 a number of factors that could affect the participation of African Americans in the research. It is imperative to appreciate the issues of the African American so that the model of recruiting clinical trials in future can be designed to address the barriers to participations (Chandra & Paul, 2003, p. 38). Their attitudes and beliefs play a very vital role in influencing their decisions to accept participation or not. As a result, it is essential that researchers understand these factors about African American potential participants. It is possible that they will readily accept participation if they are invited convivially and actively kept engaged throughout the studies (Chandra & Paul, 2003, p. 38).
Aim & Objectives
Aim: To identify the barriers related to low participation of African Americans in clinical trials.
- To explore the reasons why urban African Americans find it difficult to participate in clinic trials including social aspects like socioeconomic factors (e.g., income, education, values);
- To assess urban African American perception of their low participation in clinical trials.
- To evaluate the role of discrimination and racism on 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.
The focus groups in this study will be recruited on a broad sample base, diverse with regard to Chicago’s Southside, gender, age, and economic conditions. Eight to ten participants will make up each of four groups, who will be recruited through clinics and shelters.
Subject recruitment will take place through face-to-face meetings at the selected clinics and shelters. Potential participants will be provided with a Participant Information Sheet that describes the study and the focus group process. In addition to the focus group, potential participants will be asked to complete a brief questionnaire about their attitudes toward the clinical trials medical establishment. This questionnaire will be given in at the beginning of the focus group. Initial skepticism and unwillingness to be a part of medical research is expected, but the student investigator will explain to potential participants the benefits of the study and assure them of their privacy, informed consent, voluntary participation, anonymity and confidentiality.
Focus group meetings will be set up to accommodate participant schedule when possible in private meeting rooms at the shelters and church conference room on Chicago’s Southside. Prior to 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 posed by the moderator/student investigator. Participants will be asked to respond to questions related to:
- Knowledge of clinical trials
- Importance of the use and role of clinical trial in diagnosing and treating diseases
- Attitudes toward participation in clinical trials
- Overall level of trust for doctors
- Experience with medical treatment given
- Recommendations for improving 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 design is used 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 pattern can be assessed based on other specific hypothetical points of view.
The questionnaire containing the10 to 12 multiple-choice questions will be reviewed to provide a detailed assessment of the interviewees’ response.
Audiotapes will be used to record the information from the focus group discussions. These tapes will also be reviewed along with the notes taken from the focus group sessions and all information will be transcribed, coded and used in the analysis.
Ethics: Approval will be sought from the New England Central IRB ethics committee because the study will involve interviews. Finally, prior to recruitment, this study will seek Institutional Ethical Committee approval from the University of Liverpool.
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:
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