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Clinical Trials

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Running head: Increasing Recruitment and Retention of Minority People in Clinical Trials

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Introduction

Clinical trials are faced by numerous problems among them being difficulties in recruitment and retention of minority groups. The challenges that are faced in recruiting and retaining these groups have been well documented through various researches. In order to successfully recruit and retain minority people in clinical trials research in the health fields must undertaken beyond the traditional methods so that the barriers prevalent in the process of recruitment and retention can be overcome. Some of these barriers are related to mistrust and fear of science-based experiments following a history of atrocities committed in the name of science (Area, Alvidrez, Nery, Estes, & Linkins, 2003). This essay is going to highlight the strategies to increase recruitment and retention of minority people participation in clinical trials.
Discussion
Background Ethical consideration in medical research and clinical trials particularly with regard to humans came into the limelight in the first half of the 20th century following the medical experiments conducted by the Nazis on humans. These experiments saw the development of the Nuremberg code, which began a wide range of regulations that emphasized on the need for the protection of human beings who participated in trials that were prevalent in medical research. Principles that were articulated under the code converged to respect and justice for humans undertaking the clinical trials. However, the adoption of these principles did not stop dubious clinicians from conducting a research dubbed Tuskegee experiment on a large number of African-American who had hitherto been diagnosed with syphilis. These patients were left untreated for years so that the researchers could ascertain the course of the venereal disease. This long experiment on humans provided the genesis of mistrust and suspicion that could be the probable reason for lack of participation of minority populations in clinical trials (Hussain-Gambles, Atkin, & Leese, 2004). The Tuskegee experiment and other subsequent clinical researches that went awry led medical research committees to be more cautious even to the extent of avoiding minority populations in their medical research. Moreover, the professional researchers even labeled the minority populations as problematic and challenging. In the light of this, challenges emerged from the scientific community with the community seeking an explanation as to why there was a routine exclusion of minority populations from clinical researches. Subsequently, the US government formulated and implemented National Institute of Health (NIH) guidelines with the aim of including minority groups into clinical trials. However, this move led to numerous discussions on minority groups, which led to perceived difficulties for implementers that came from the crude concept of ethnicity, ambiguity of cultures and race, which make recruiting, and retaining of people from minority groups a huge problem (Hussain-Gambles, Atkin, & Leese, 2004). Methods used by researchers Researchers have used several methods with the view of understanding the phenomenon of exclusion of minorities in clinical trials. The use of literature review on conduct and subsequent reporting of trials carried out in clinics is important in assessing the type of population that is normally used to carry out clinical trials. This literature review is also important in elucidating the type of exclusion criteria that is assumed by the professions carrying out research on medical matters. Other areas that are addressed using literature review approach include the connection between minority populations and clinical trials, debates on the data that is derived from clinical trials and methods, which provides for diversity in the samples that are used in medical trials. Another method important in availing data necessary for study about disparities in clinical trials is the use of online searches for both published and unpublished work whereby numerous relevant works are present in databases such as Medline, Ethnicity database among others. Scanning of bibliographies, use of government databases, and ongoing researches that are relevant to the topic were also core to bringing out information on exclusion of minorities from clinical trials and suggestion of ways to incorporate these populations (Yancey, Ortega, & Kumanyika, 2006). Results Results from literature reviews and numerous studies on the reasons for lack of minorities in clinical trials showed that majority of the participants in clinical trials are the majority population groups who are educated and have a good socio-economic background. The reasons for the prevalence of majority groups and significant absence of minority population groups can be traced to indifference nature of healthcare providers who are not fully aware of the benefits of using a representational sampling. Other reasons are the infamous historical practices in clinical trials and bad attitude by the minority population with regard to clinical trials. Women of childbearing age are among the minorities who have been excluded from the clinical trials on the grounds of ethical considerations (Yancey, Ortega, & Kumanyika, 2006). The criterion of exclusion also bars old people from participating in these medical trials due to perceived fragility. From the reviews, the justification for excluding ethnic minority populations and people from poor social-economic backgrounds is solely to protect them from exploitation and manipulation. This exclusion depletes the research important information, which could be of enormous important to the medical fields. Moreover, results from the research show that exclusion of individuals on grounds of inability to speak fluent English led to shying away of the individuals even though the trials were conducted in their vicinity. The use of racial profiling when conducting trials is an example of the reasons for the conspicuous absence of minority groups in clinical trials. Given a history of evils conducted on the medical front, the issue of mandatory inclusion in clinical trials of people from all races may elicit racist thoughts (Hussain-Gambles, Atkin, & Leese, 2004). Barriers There are barriers that lead to a lack of participation of the minorities in clinical trials notwithstanding the evolvement of clinical trials. The process of planning and arranging for the minority populations to undertake research has continued to face major impediments. Among the numerous barriers is cost. This is because in order to perform analysis the inclusion of minor groups in medical research means that more medical practitioners have to be recruited to the process, which translates to additional costs. Moreover, additional costs also do arise from the need for employment with a thorough understanding of the language and culture of these minority groups. Failure to expend funds following translation and accommodation may bring more problems as communication barriers mar interactions that include minority communities (Hussain-Gambles, Atkin, & Leese, 2004). An inappropriate exclusion criterion is another barrier that is prevalent in the process of recruitment and retention. The minority populations are excluded due to inability to speak and understand English, which is the medium of conducting clinical trials. There are no existing arrangements that cater for the lack of consent between researchers and the minority populations that is brought about by language barrier. Moreover, since the clinical trials require consent forms and sheet of information which are annotated in English, the failure to understand their content evokes fearful memories given that infamous experiments were conducted due to lack of consent from the humans undertaking trials. In addition, the problem of language comes is synonymous to other related barriers such as stereotypes, myths and cultural disparities which pose an impediment to the process of communication (Hussain-Gambles, Atkin, & Leese, 2004). Another barrier in recruiting and retaining minority groups in clinical trials is the social-cultural barrier. This come from research related to health, which indicates that ethnic minorities receive unequal treatment. Disparities in the provision of healthcare arise from difficulties in accessing the target patients, the social and economic background of patients and the concept of race. Moreover, inequalities in provision of healthcare and clinical trials differences in social-economic factors, which are somehow. This major barrier explains the lack of participation of minority populations in clinical trials (Hussain-Gambles, Atkin, & Leese, 2004). There is a major barrier in distrust that comes from minority people and hinders the process of recruitment and retention in clinical trials. Among the parties that are heavily distrusted by these communities, include the scientific researchers, the government and the academic institution undertaking the researches. This mistrust comes from fear of exploitation and mistreatment, as these populations are aware of the guinea pig treatment given to other humans in the name of research. Moreover, severe mistrust comes from the concerns of these individuals that the data collected from them is solely used to further the researcher’s careers whilst portraying the participating communities in a bad light rather than addressing the predicaments that are facing them (Ejiogu, Norbeck, Mason, Cromwell, Zonderman, & Evans, 2011). A general lack of medical knowledge prevalent in these populations is another impediment to the process of recruitment and retention of minority populations in clinical trials. Most of the people in minority populations lack a medical knowhow due to higher levels of illiteracy that are prevalent in these populations. Such an impediment coupled by the fear of exploitation by medical researchers is a great barrier, which discourages researchers in their quest to inform the communities about the benefits of medical research. Individual barriers are prevalent in minority populations, which greatly hinder participation in recruitment and retention in clinical trials. These barriers are transportation barriers as most of these population reside in remote areas that are somehow inaccessible. Time and economic constraints are individual barriers that face most of the people in minority populations. Moreover, the burden of the disease may be another impediment to participation in clinical trials whereby the afflicted individuals from minority populations are unable to afford medication and hence highly vulnerable to poor management of their ailments. Other individual barriers include personal bias where the targeted individual fail to welcome medical researchers and social and behavioral factors whereby the targeted individuals maybe drug addicts which may lead to their automatic exclusion (Ejiogu, Norbeck, Mason, Cromwell, Zonderman, & Evans, 2011).
Strategies to alleviate barriers and increase recruitment and retention In order to remove the barriers that the medical practitioners face and increase recruitment and retention of minority populations in clinical trials, the minority populations and the healthcare providers have enormous tasks to partake. Barriers that are related to lack of trust on the scientific researches and healthcare providers can be eradicated through the improvement of communication between the minority communities and the medical experts conducting the clinical trials. This can be done through the research team offering guideline to the participants on medical benefits accruing from research and mentioning of the health centers that are willing to offer treatment to members from these populations. Trust is a vital element in promoting communication and the researcher can instill it to the participants by identifying themselves with badges. The improvement of communication will help dispel fears hitherto instilled due to ignorance as well as increasing the prospects of participation by the minority populations and convergence of the goals of these populations and the medical researchers. Another strategy that is core in addressing the problem of lack of participation of minority populations in clinical trials is provision of medical knowledge using influential groups in the particular communities such as neighborhood activists, church leaders and influential residents among others. These individuals should enlighten the masses on the existence of health disparities and benefits accruing from research. This strategy is important in enabling the minority populations to gain trust on medical researches since prominent individuals are often revered in these societies. Moreover, the use of these individuals help in limiting barriers that are community based. The concept of community involvement is a strategy that is core in facilitating participation from members of minority population. Apart from trust, this strategy alleviates barriers that result from negative attitudes about clinical trials. Community is involved using workers from the minority population that is being targeted. The use of churches is a good avenue for targeting minority population with the view of informing them about the beauty of medical research. However, the church has been known to provide negative views especially with regard to infamous historical medical experiments that targeted minorities (Hussain-Gambles, Atkin, & Leese, 2004). Through intense follow-up of the participants and close contact with them, there will be an improvement in participation of the minority population and subsequent retention. This follow-up is enhanced through the use of the same staff who have the task of providing support and availing themselves in due time through establishment of accessible locations. Moreover, the medical staff responsible for carrying out research should have a prior knowledge of the dynamics of the families in minority populations (Hussain-Gambles, Atkin, & Leese, 2004). Provision of incentives to the participants from minority population is another strategy that can ensure an awesome engagement in participation in clinical trials. These incentives are usually given to the participants so that they can provide relevant data and thoroughly cooperate with the medical researchers. A particular survey on participants from a minority population afflicted with breast cancer showed that incentives could play a role in trying to decipher information from minority populations. However, such incentives need to be timely enough for maximum cooperation (Leathem, et al., 2009). In overcoming individual barriers, several strategies need to be adopted. The researchers can avail themselves to the potential participants hence alleviating the barriers resulting from transportation. This can lead to enrollment by participants who had hitherto lacked a means of transport to the research facilities. Time and economic constraints can be addressed through monetary remuneration, which is a definite motivator for participation. Moreover, the trials should be scheduled to suit the demands of the participants notwithstanding the remuneration. The disease burden is another barrier, which can be addressed through provision of opportunities for medical examinations and testing which are unaffordable to the participants from minority populations (Levkoff & Sanchez, 2003). Regulations concerning minority groups Regulations concerning minority groups came following the protection that was offered to these groups after fatal medical experiments came to the limelight. Through various reports which emphasized on the need for respect and justice, medical researchers began labeling minority groups as challenging to deal with which led to imposition of regulations with the aim of excluding these groups. Moreover the groups had apart to play as mistrust cropped in which prevented them from engaging in genuine clinical trials. However, these regulations have been eradicated through the stipulation of guidelines by the US government, which require the minority groups to undertake clinical trials. The eradication of the regulations concerning minority groups is important in the sense that clinical trials are more genuine and have evolved greatly through collaborations of professionals in the medical field, healthcare’s support staff and coordinators responsible for clinical trials. Furthermore, the issues regarding medical ethics have been thoroughly addressed alongside the barriers that impede the minority groups from participating in clinical trials. In the light of this, minority groups need to be comfortable whilst participating in clinical trials (Hussain-Gambles, Atkin, & Leese, 2004). Conclusion In summary, the problem of lack of participation by minority groups in recruitment and retention has proliferated in clinical trials following fatal accidents that came because of medical research. This paper has highlighted the genesis of the problems that led to lack of participation of most minority populations. Moreover, there have been efforts that have been put in place with the view of ensuring that minority populations are able to participate in clinical trials. These efforts include the addressing of issues that concern medical ethics and removal of barriers that have impeded the participation of minority groups. The aforementioned efforts have ensured that the minority groups are comfortable with clinical trials.
References

Area, P. A., Alvidrez, J., Nery, R., Estes, C., & Linkins, K. (2003). Recruitment and Retention of Older Minorities in Mental Health Services Research. The Gerontologist , 36–44.
Ejiogu, N., Norbeck, J. H., Mason, M. A., Cromwell, B. C., Zonderman, A. B., & Evans, M. K. (2011). Recruitment and Retention Strategies for Minority or Poor Clinical Research Participants: Lessons From the Healthy Aging in Neighborhoods of Diversity Across the Life Span Study. The Gerontologist , S33–S45.
Hussain-Gambles, M., Atkin, K., & Leese, B. (2004). Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health and Social Care in the Community , 382–388.
Leathem, C. S., Cupples, M. E., Byrne, M. C., O'Malley, M., Houlihan, A., Murphy, A. W., et al. (2009). Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Medical Research Methodology , 1-11.
Levkoff, S., & Sanchez, H. (2003). Lessons Learned About Minority Recruitment and Retention From the Centers on Minority Aging and Health Promotion. The Gerontologist , 18–26.
Yancey, A. K., Ortega, A. N., & Kumanyika, S. K. (2006). Effective Recruitment and Retention of Minority Research Participants. Annual Review of Public Health , 1–28.

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