Clinical trials in America have faced quite a number of challenges whereby a large population of African American citizens is not accommodated into the tests. However, the population of African American people is uneven with about 13% represented in America. During clinical trials, this population tends not to be accommodated into the cohort and thus the trials are only done on white people producing results that are not effective.
Lack of participation by the African Americans has brought difficulty in bringing out results in a broad view perspective as it is limited mainly to the white people. Approaches to enable the urban African Americans to participate have also been limited by several factors like scarcity in Science to direct the investigators on how to perform the trials, lack of direction on how to put into action the goals and objectives. The researchers also fail in understanding the methods to which they would assess the results of their study.
In 2003 Corbie-Smith and other authors published a study that was done without representation of all ethnic groups and concluded that the study was not genuine as the outcomes could not be generalized to give a positive broad view perspective of the study. Lack of participation of African Americans participation has also been brought about by unequal distribution of healthcare services, no access to superior health stations, and a broad variation in diseases and medical conditions. Investigators at the National Institute of Health did a study and proved that lack of participation by a marginal society in health research was a big misapprehension and it does not harm the outcome of the research as compared to the non-Hispanic whites (Wendler et al., 2006). However, a mandate by the National Institutes of Health Revitalization Act 1993 dictates that a wide range of marginal communities is required to produce a generalized positive outcome. On the other hand, this mandate has not been followed to the latter to produce beneficial results to aid in the healing process.
The general reason as to why African Americans do not tend to participate in clinical trials are mainly due to fears by the individuals, scarcity in proper health care services, certain cultural practices, peer discouragement from other individuals and unfairness based on nationality and ethnic groups. Doctors have also taken part in baring African Americans in participating in clinical trials by not advocating and proposing they to be included in the clinical trials. An article published by the National Medical Association highlights that all Clinical trials should give a precise and systematic answer to any query or issue on the screening, diagnosis and prevention of the disease (Powell, 2008).
Despite the fact that the National Health institute demands that there should be equal distribution of ethnic groups represented in clinical trials, there’s still a decline in the population of African Americans taking part, this is due to a lack of confidence in this community. The Tuskegee Syphilis Study that was done years ago led to a discreditable outcome on American research with a large population of African Americans not receiving treatment over a period of about forty years. African Americans lost trust in clinical trials since then and there has been a continuous decline in their participation (Mason, 2005).
Even though controlled clinical trials have been depicted to produce effective trials, the perception tends to fail if the required target group is not included in the study. This mainly involves the use of factors like age, gender and the minority group which is usually excluded (Britton et al., 1999).
The reduction in participation by African Americans has led to a high percentage of despondency to healthcare conditions whereby medical research has been limited to produce results based on a limited population. Owing to the limitation, there has been a failure in research done in the development of new remedies and drugs. Lack of participation by this group of people may bring out a miss in certain parts of the research like difference in genetics and response to drugs. Genetic combinations are different in human beings, African Americans may poses a variety of genes which if not taken into consideration may lead to unwanted expenses brought by pressure to meet the special needs of the individual (Swanson & Ward, 1995).Thus, investigators need to put out and fight the barriers to participation by the African American population by clearing the mistrust and encouraging effective communication between the patient and the physician.
Nevertheless, it has been noted that there is a number of studies done to determine the barriers to African Americans participation in clinical trials, much effort should be put to determine what would lead to an improvement to the participation (Chandra & Paul, 2003).Thus the study should incorporate the factors limiting participation of the African Americans and data collected in a form of questionnaire and centre the attention in bridging the gap.
Aim & Objectives
- To determine the barriers to participation in clinical trials by African Americans
- To determine barriers to low participation by African Americans in clinical trials.
- To determine ways of improving participation of African Americans in clinical trials.
- To determine the economic and social factors that hinder participation of African Americans in clinical trials.
- To assess how racism leads to low participation of the African American Population.
The study will use qualitative research approach as it does not put much control or limitation on finding the barriers to low participation and recruitment of the participants. The recruitment will be based on broad sampling on age, gender and economic status and grouped into four of ten factions.
A participant information sheet will be provided to the participant with a brief questionnaire to determine his/her feelings towards the study. The participant will also be informed of her participation being voluntary and sign a consent form upon agreement to take part in the study.
The participants will be questioned on:
- Reasons for lack of trust on clinical trials.
- Relationship between them and their physicians.
- Fears of clinical trials.
- Benefits of clinical trials.
- Ways to improve participation of African Americans on clinical trials.
A code will be assigned to each issue. Consistency and differences on the codes will then be used to evaluate the issues that are more prominent in the findings and identify ways to improve participation by the African Americans. This routine is effective as it creates room for personal experiences without holding it on scientific objectives. It also brings out theoretical patterns which can be linked to specific supposed theories collected in the data. Ethical research committees will then approve the study and final approval done by the institution.
The study will find out the ways to improve participation of African Americans in clinical trials and incorporate the barriers to their participation to find ways to curb them.
Costs will be on refreshments, transport and office stationary. A total of $100 will be used on each group.
|March- September||Proposal Development||This will include drawing up of the proposal on what is to be done, the objectives of the study and the routine to how the study will be conducted.|
|October||IEC submission||The data collected will be handed over to the IEC for approval.|
|November – December||Enrollment of Focus group||Conscription of the focus group will be done carefully through interviews.|
|January-February||Data analysis||Data collected will be analyzed with codes based on the participant’s response.|
|March – April||Recommendation||I will make recommendations on how to improve African American Participation in clinical trials based on the findings from my study.|
|Conclusion||1 week||Any revision required will be made prior to the submission date.|