Low Participation in Clinical Trial by African Americans

Topic: Medicine Words: 2236 Pages: 9 Updated: Aug 22, 2022

Introduction and Background
Literature Summary
Aim & Objectives
Methods
Research Outcomes
Costs
Timetable
References

Introduction and Background

The African Americans comprise 13 percent of the overall population but account for a disproportionate percentage of heart disease, breast cancer and other health-related problems. Basing drug trials on white populations has often proven ineffective for this highly vulnerable group. Therefore the low participation of African Americans in clinical trials becomes a high priority subject.
Corbie-Smith et al. (2003) stated that the many hindering factors in clinical research brought about by racial or ethnic minorities cannot be compared to the results and findings. He further explains that the inability to conduct subgroup analysis is caused by the lack of access to state-of-the-art treatment for various health conditions. It is also questionable equity in health. The Major inequalities in health outcomes occur when ethnic and racial communities have not been represented fairly or adequately in medical research. A much wider inclusion of minorities in clinical research and trials is an urgent need according to Heiat et al. (2002). This has also been the mandate of the National Institutes of Health Revitalization Act 1993. Green et al. (2001) believe that, despite the mandate, the inclusion has not been consistent enough to be reflected in guiding results of therapeutic decisions. Although the problem has been deemed with greater concern and attention, significant strides are required to advance empirical evidence that explains the current status quo in clinical research. Establishments of common misconceptions such as racial or ethnic minorities being lesser 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).

Literature Summary

The article Increase Minority Participation and Awareness of Clinical Trials by The National Medical Association gives some beginning of insight into barriers related to participation. It has been described as a step-wise process in which a new procedure, drug, vaccine, or device is examined on humans. Each trial is meant to provide an answer to the scientific questions in the pursuit of prevention, screening, diagnosing, or treatment of a disease that meets the set standards (National Medical Association, 2008). After an insight on the importance of participation in clinical trials is briefed to the reader, the common reasons as to why African Americans do not participate in clinical trials are highlighted. Some of them include; Little or lack of awareness, limited access to proper healthcare, recommendation refusals by doctors, personal fear/distrust, cultural beliefs or myths surrounding it, and discouragement due to the racial and ethnic discrimination they are subjected to to are some of the secluded reasons. National Medical Association (2008).

Mason (2004) categorically mentions in his article that African Americans, as a cultural or racial community, are susceptible to feelings of uncertainty when participating in clinical trials. This is mainly because of issues of trust with the research community dominated by the White Caucasian population. He elaborately draws attention to 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, says Mason that has made the victim community wary of any research conducted by any Great White Man.

Preealman (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. Despite the fact that researchers like Herring et al. (2004) and Ness et al. (1998), have to some extent raised evidence on this, most of them couldn’t show the number of clinical

Trials that have widely varied as per the possibilities of the subjects being used as the recipients. Women, children, the aged and ethnic/racial minorities frequently fall into blanker exclusions, a category in which subjects automatically get excluded (Britmn et al. 1999; Curry 1997). The study described in this article was designed to identify the barriers to African-American participation, as they are prominently the most significant minority in the country, in clinical trials. Thereafter the study proposed solutions to overcome these barriers will be made.

Aim & Objectives

The main aim of the dissertation is: To determine factors that may help explain the low participation rate of African Americans in clinical trials on Chicago’s Southside.

Objectives:

To explore the reasons why urban African American communities face a number of challenges in the clinical trials;
To explore how social aspects like socioeconomic factors (e.g., income, education, values), may influence urban African Americans’ participation in clinical trials;
To explore how urban African American perceive the low participation of other African Americans in clinical trials and how this may impact their future participation;
To evaluate how discrimination and racism influence participation of urban African Americans in clinical trials.

Methods

This study will utilize a qualitative research approach. Qualitative research is a more suitable methodology keeping in view that the topic for the dissertation research is Low Participation in Clinical Trial by Urban African Americans; barriers in recruitment and the methods of recruitment for improving participation. Through the qualitative paradigm, the opportunity is lesser constrained in exploring the multitude of reasons behind low participation, barriers in recruitment and the extent to which their participation can be improved through methods of recruitment.

Through focus groups of African Americans, low participation will be assessed in a detailed manner in this study. Focus group study and interviews provide the suitable advantage of exploring the pertinent issues, including the way participants perceive themes as they live. Through this procedure, one can investigate how the enrolled participant comprehends experiences, how much and what kind of knowledge he carries and even the reasons why the involved beliefs in what he does.

For the sake of gathering information from which conclusions are accurate and generalized focus groups will be used. I will be responsible for conducting the focus group to visit a nursing home, two clinics and one shelter. The focus groups in this study will be based 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 group, who will be recruited through nursing homes, universities and shelters. This will result in a diversity of class, gender and age that will provide for a wider sampling and better analysis. There is an ever-present possibility that subjects who participate in a focus group might also be, otherwise, disposed to involve themselves in such settings, making their participation or headcount as deviant from the average in clinical trials. To purposefully access the average minority, tactful methods must be used as a short sample questionnaire to be filled by a potential participant beforehand, so as to get some measure or an idea about their attitudes towards the medical establishment. Initial skepticism and unwillingness to be a part of medical research is expected out of, at least, half of each focus group’s participants. Further, selecting subjects through public ad postings will only defeat the purpose, thus, it must follow a much safer and more personal protocol of Black men and women who visit schools, clinics and shelters to survey and recruit potential participants (Adams et al., 2004)

Prior to recruiting for this study, IEC approval will be sought from the University of Liverpool. For transparency in the process, participants will be provided with a covering letter, along with the questionnaire, which clearly states the motive behind the research through which he or she could consent to and participate with enthusiasm.

Focus group meetings will be set up to accommodate participant schedules when possible. Prior to the start of each group meeting, consent will be provided and obtained from each participant. During the discussion, several key questions will be posted by the moderator. Participants will sit through questions on their encounters with medical research and treatment in the past, the extent to which they are aware of the tensions between the medical establishment and the African American community. The sources through which they know and how it influences or shapes the way their particular social group is perceived, that is, do they know about the Tuskegee syphilis experiment and how does it affect their self-understanding as a black person in relation to medicine? Do they distrust doctors, and if so, to what extent is this feeling inherited from their social network? The kind of attitudes they have towards the diagnosis and treatment of disease; and the reasons that prevent them from participating in a clinical trial, along with the things that they would have to change in order for them to do so.

Strauss’s Grounded Theory would help to systematize the findings of these focus groups, as it allows the scattered and diverse findings from the field to be coded and compared (Ratcliff). Through the system of coding, Strauss’s method will narrow down and identify the problems and issues of the subjects of focus groups encounter during clinical trials that is, preconceptions of the medical establishment and past experiences with doctors. 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 all of the focus groups’ field notes, and then using this information to identify which issues are the most prominent and specific to communities most affected by them and overall, in what ways they contribute to African Americans’ clinical trial experiences. The methodology in Grounded Theory 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 individual concerns of African American patients and a general picture of the African American social experience with clinical trials get accounted for adequately as much as accurately in this method.

Research Outcomes

The dissertation will help in reaching a conclusion that emphasizes how the participation of African Americans in clinical trials is low.
It will also be found out that it is much lower than their representation in the general population and in proportional comparison to the representation of other communities.
It will be further understood that both the participants under study and the researchers may be causing barriers to the participation of African Americans, with their respective attitudes and perceptions towards each other.
It is therefore imperative for the researcher to take appropriate steps to reduce if not eliminate as many barriers as possible.
This will be done by identifying the potential barriers that hinder African American participation in clinical trials.
For increased African American individuals’ participation in clinical trials, a strategy will be devised on plans, procedures and targeted goals.

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.

Timetable

The Research is to be divided into different parts, starting from June 2010 to July 2011

Time Frame	Activity	Description
June to November	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 in order 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.
January	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 authorised.
February to May	Recruitment of Focus group	The members of the focus groups are to be carefully selected preferably through interviews so as to ensure the data is well collected.
May to June	Data analysis	Analyse the data using thematic analysis. I will develop a codebook based on participants’ responses and use it as a guide to organizing all the transcribed data.
July	Recommendations	Based on 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. Prior to this, I will make any and all revisions needed

References

Adams-Campbell LL, Ahaghotu C, Gaskins M, et al. Enrolment of African Americans onto clinical treatment trials: study design barriers. J Clin Oncol 2004; 22(4):730–4.

Corbie-Smith G, Ammerman AS, Katz ML, et al. Trust, benefit, satisfaction, and burden: a randomized controlled trial to reduce cancer risk through African-American churches. J Gen Intern Med 2003; 18(7):531–41.

Green BL, Partridge EE, Fouad MN, et al. African Americans attitudes regarding cancer clinical trials and research studies—results from focus group methodology. Ethn Dis 2000; 10(1):76–86.

Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med 2002; 162:1682–8.

Herring P, Montgomery S, Yancey AK, Williams D, Fraser G. Understanding the challenges in recruiting African Americans to a longitudinal cohort study: the Adventist health study. Ethn Dis 2004; 14(3):423–30.

Ness RB, Nelson DB, Kumanyika SK, Griss JA. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol1997; 7(7):472–8.

Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Med 2006; 3(6):e19.