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.
Very few studies have elaborated the attitudes, beliefs, and fears of African-American people about hindrances to their participation in clinical trials and scientific studies. So far, most of the research carried out entailed the utilization of relatively small sample size and as such limiting the validity of the results obtained in such studies.
Consequently, a select population usually oncology patients has been utilized in the majority of these studies further limiting the validity of the outcomes. 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.
This is crucial especially when it comes to those diseases and conditions that are widely known to affect Caucasians. In such cases, there is a tendency to extrapolate the findings to other ethnic groups when in reality the findings won’t be of any value to these minority groups. Models aimed at addressing this issue need to be designed to give guidance to 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) mention that several limitations of clinical trials are due to poor representation of racial/ethnic minorities in most clinical trials carried out in the United States of America.
The findings cannot be generalized because there is an inability to conduct subgroup analyses, which leads to a 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.
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 of these minority groups has not been consistent enough to produce results that might guide therapeutic decisions.
Although the problem has been deemed with greater concern and attention, significant strides are required to advance the current status quo in clinical research. The main goal of this study is to ascertain the reasons behind the low participation of African Americans in clinical trials.
Furthermore, the study aims at identifying the barriers that prevent the full participation of this subset in clinical trials. The study will also put forward recommendations on what needs to be done to improve the current status quo.
Literature Summary
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, recommend. Action 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 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.
Their 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 when it comes to clinical trials and other scientific studies (Britton et al., 1999).
Also, the ethical conduct of many researchers and those involved in carrying out in the study has been questioned as some of these researchers end up exploiting the minority groups in the name of research. Consequently, there is a misuse of the concept of the informed consent by some researchers especially when minority groups are involved in the studies.
This stems from the fact that one may not get adequate representative samples when dealing with these groups. 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.
As a result, developments of specific drugs or therapies fail to cater to special needs that African Americans may have like genetic predispositions to certain ailments. 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 investigator’s 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 shy away from clinical trials and other medical statistics as they have a lot of barriers to the come for them to take part in the trials.
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. 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 a need to identify any background information about the barriers to participation for some regions, before the commencement of any recruitment process (Chandra & Paul, 2003). However, an exploration of the barriers to recruitment and retention has not been undertaken in many urban areas of the United States. Also, while some studies have focused on the barriers, the root causes have 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 a change in approach when dealing with the African American population on how their participation can be increased.
I hope to gather this information from the questionnaires administered to focus groups of African Americans. This means that factors hindering participation or affecting retention will be incorporated in the study questionnaires created to obtain relevant information from Chicago’s Southside African American 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 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 participation (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 factor,s 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 studio es (Chandra & Paul, 2003, p. 38).
Aim & Objectives
To identify the barriers related to low participation in clinical trials amongst urban African Americans in the US.
- To explore the reasons why urban African Americans find it difficult to participate in clinical trials (i.e., social aspects, socioeconomic factors, etc.);
- To assess the knowledge, attitudes, and perception of clinical trials among urban African Americans.
- To evaluate the role of access to care and past experiences with the medical community and its influence on urban African American participation in clinical trials.
- To suggest ways to improve participation and retention in clinical trials by urban African Americans.
Methods
Focus group sessions will be conducted at the St. Bernard’s Hospital in Chicago’s Southside. The hospital is an urban public hospital that serves the majority of the African Americans who reside in Chicago’s. 54.2% of the population served comprises of women.
Participants and Sample Size
Participants will be recruited from the outpatient department of the St. Bernard’s Hospital. Also, other participants will be recruited from the oncology clinic of the same hospital. This will be carried out by a research assistant or student investigator at the registration desk of the two departments in collaboration with the registering clerk.
If possible, the investigator in charge of recruiting the patients will be an African American. For one to be included in the study one needed to be An African American or had at least one parent who is African American if one is of mixed ethnicity. This was facilitated through the use of a screening tool that comprised of questions on ethnicity, address, and history of having taken part in any clinical trial.
The participants will be selected in such a way as to reflect the clinic from which they are recruited. The target sample size is 100 people of African American ethnicity who reside in Chicago’s South Side. The justification of the sample size entails the funds available to carry out the study.
Also, the sample size is adequate for giving us insight into the reasons as to why African Americans are reluctant to participate in clinical trials. The study will employ a judgmental sampling technique where a framework will be developed to sample the patients visiting the St. Bernard’s Hospital in Chicago’s Southside based on the laid down inclusion and exclusion criteria.
The study will involve the inclusion of all possible variations in the sample such as maximum variation samples, possible deviant samples and critical case samples to ensure the study remains validity and to minimize bias in the sampling procedure. Furthermore, due to the possibility of some of the African Americans declining to take part in the study, the sample size of 100 would be appropriate to work with a P value of ˂ 0.05.
Study Design
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 how participation can be improved. About the unavailability of enough information and data on this subject, the study will employ the use of focus groups.
This is because there might be other reasons and beliefs that make African American people have reluctance in participating in clinical trials. Also, the focus groups will identify any sources of bias that may occur during the study as the participants may be afraid to take part even in this study.
The focus groups will consequently provide room for making generalized conclusions as to the reasons why African Americans are reluctant to participate in clinical trials. The focus groups in this study will be recruited on a broad sample base, diverse about Chicago’s Southside, gender, age, and economic conditions.
The focus groups are necessary as they will provide information on the collective fear of participation in clinical trials that African Americans have. Subject recruitment will take place through face-to-face meetings. 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. The questionnaire is required to gather as much information as possible from the participants. 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 purpose 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 schedules when possible in private meeting rooms at the shelters and church conference room on Chicago’s Southside. Before the start of each group meeting, consent will be sought from each participant. During the discussion, several key open-ended, non-leading questions will be posed by the moderator/student investigator.
At any one time during the recordings, there will be a researcher who will be noting down any verbal and non-verbal communications from the participants. At the end of the session, each participant is to receive an honorarium of $20. Participants will be asked to respond to questions related to:
- Knowledge of clinical trials
- Importance of the use and role of a clinical trial in diagnosing and treating diseases
- Attitudes toward participation in clinical trials
- The overall level of trust for doctors
- Experience with the medical treatment given
- Recommendations for improving clinical trial participation in the African American community
Data Analysis
Thematic analysis will be used to summarize the findings of the focus groups, as it allows coding of the scattered and diverse findings from the field (Chandra & Paul, 2003, p. 48). In the thematic analysis, themes are designed and developed, and their associations to each other elucidated into a defined code. Thematic analysis entails two forms of coding namely relational and open coding.
Relational coding will be employed in this study to generate codes in the different focus groups. This is followed by evaluating consistencies and differences among the codes in the focus groups’ data, and then using this information to interpret and 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 its versatility in as it provides a way of assessing the complexities of personal and social experience without divorcing itself from scientific rigorousness. The questionnaire containing the10 to 12 multiple-choice questions will be reviewed to provide a detailed assessment of the focus groups’’ response.
Audiotapes will be used to record the information from the focus group discussions. The tapes will then be transcribed into notes, and all information will be coded and used in the thematic analysis.
Ethics
Approval will be sought from the New England Central IRB ethics committee because the study will involve interviews. Finally, before recruitment, this study will seek Institutional Ethical Committee approval from the University of Liverpool.
Research Outcomes
This research aims to describe 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.
Costs
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.
Timetable
Research has to be divided into different parts, starting from:
Reference List
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 Randomized 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 natl 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