Approach
The proposed study is to examine different ways of intervention to promote racial and ethnic diversity in clinical research studies and the labor force. In addition, it aims to show the medical and scientific rationale for ensuring that the demographics of clinical trial participants match those of patient groups. Moreover, it seeks to improve organizational cultural competency, which has been identified as a crucial element in the effective incorporation of minority groups into the clinical research workforce (Aysola et al., 2018). Through these techniques, the initiative intends to promote the creation of a more multicultural and diversified clinical research workforce coordinated by an institution-level plan for inclusion and diversity. Similarly, it seeks to promote the training of responsible academics to lead the absorption of diversity and inclusion objectives and efforts. In addition to supporting efforts to enroll, retain, and graduate students from underrepresented backgrounds, the study will encourage adherence to policies that proactively identify and retain personnel from diverse racial and ethnic groups. Finally, it seeks to outline criteria for assessing the success of proposed methods of ensuring diversity and inclusion of minority groups in the clinical research workforce.
Methods
Aim 1: Evaluate a potential intervention to improve ethnic and racial diversity in clinical research studies
A conceptual framework is developed using an analysis of the most certain gains from promoting diversity and inclusion in the clinical research workforce. Independent variables for the theoretical framework were identified by reviewing the relevant literature. The value of a diverse and inclusive clinical research workforce will be evaluated as an independent variable to determine its impact on reducing health disparities among marginalized groups. It is crucial, for instance, to think about the relationship between the majority and minority races at clinical research facilities since this directly impacts the results of clinical trials. Current guidelines and standards regarding diversity and inclusion in research will be examined since they impact researchers’ practices. Indeed, a survey of the relevant literature has shown the absence of defined policy standards governing the involvement of different workers in the clinical research sector. In other words, they will give significant insight into which policy areas need improvement to accomplish the study goals. Correspondingly, the research will examine how participants feel about the racial or ethnic makeup of the clinical research study team. This independent variable is incorporated into the aforementioned theoretical framework to understand how clinical research organizations affect the results of clinical investigations.
Aim 2: Investigate and outline the efforts made by government regulators, patient advocacy organizations, and research institutes to achieve this objective by developing methodologies to meet representation in enrollment aims and expand eligibility conditions
It is determined that the quantitative research design will be used to complete the study since it will facilitate gathering information from a primary viewpoint and concentrate on current challenges influencing diversity and inclusion in the workplace. The decision philosophy of positivism is usually used against the backdrop of a quantitative research approach since it helps to avoid including personal opinions in data collection when the whole emphasis of the research is to explore the research topic. This is crucial since the people the researcher’s conclusions will most directly impact will be the key data sources or respondents. Since the investigation will be undertaken from the viewpoint of a minority group, it can raise ethical concerns, making it essential to depend on professional ethics throughout the study period. There is strong confidence that the technique will adhere to all relevant ethical standards.
The study will gather information from 20 respondents from the biopharma business, academia, and professional groups. The study’s sample size of 20 is derived from the approximate number of major clinical research organizations in the United States. In addition, data will be gathered using a random sample technique. An online questionnaire will be created and distributed to respondents so that they may give meaningful feedback without having to make personal contact. The timely completion of the procedure and complete protection of the respondents’ data confidentiality and privacy are other key objectives of the data gathering procedure. Data from the survey questionnaire will be considered when the data analysis is done to verify the validity of the conceptual framework. Since statistical analysis is the most widely used technique for evaluating the applicability of a theoretical paradigm, it will be used to analyze the data. Consequently, suggestions based on the statistical findings will be presented for consideration. Finally, the t-test will be performed to assess the reliability of the study hypothesis.
Timeline
The research timeline is developed by studying the approach utilized in the investigation. As a result, it is crucial to do the preliminary literature study before moving on to the quantitative survey questionnaire section. The strategy also includes reaching out to several clinical research organizations to get in touch with their staff members for help with data collecting. The quantitative survey questionnaires will be distributed in a way that is entirely consistent with the goals. More efforts will be made to neutralize suitable instruments to ensure timely data collection and useful results from the write-up thesis. A thorough evaluation will be conducted after the whole plan, which will be presented per the rules. The strategy will concentrate on enhancing productivity and conserving time, which is useful for engaging the research for longer.
Table 1: Research timeline
Potential Challenges and Approaches to Mitigate Challenges
In clinical research, an authority in a certain subject will analyze research, choose the significant ones, and highlight their conclusions regarding the results and technique to a limited extent. Equally possible are research recommendation topics. These narrative evaluations have two main drawbacks (Zini & Banfi, 2021). Essentially, no systematic method is advised for gathering primary data or incorporating results. Instead, the author’s subjective assessment is employed. As a consequence, there are no defined guidelines for evaluating a review’s quality. Another issue is that the narrative critic does not statistically analyze data from the literature. Therefore, the likelihood that incorrect assumptions may be drawn in a traditional literature review grows as the volume of research on any subject increases. These issues will be minimized by recording and disclosing all decisions made throughout the study screening phase. This will give the openness required for objective evaluation of the possibility of bias by other experts.
Determining the smallest/most suitable sample size requires meticulous consideration of every aspect of the research project, from the methodology to the tools for collecting data to the methods for analyzing that data. The expected sample size is 20, which is relatively small and raises several challenges. Firstly, a smaller sample size raises the probability that a faulty assumption would be assumed to be true. Therefore, the suggested solution may have no advantages compared to the current intervention. Secondly, it may be inferred that time and money resources were wasted if the findings do not offer practical solutions to the research problem. Accordingly, the research will utilize special strategies such as Bayesian analysis to overcome the difficulties associated with a small sample size and analysis.
Implications and Future Directions
Fostering inclusion necessitates a multidimensional strategy centered on comprehending the multiple and complicated nature of marginalization in clinical trials, forming relationships with populations, enhancing trial access, and harnessing healthcare technologies. This initiative is unique and can contribute to its effectiveness because the suggested solutions are the product of direct input and feedback from minority workers, patients, and other essential stakeholders who undertake the study. Relevant parties should not abandon critical tasks and obligations in overcoming participation obstacles. A participatory approach, partnerships, and alliances may offer the best chance for successful and sustained achievement.
The essential strategic aim for the future is to overcome distrust among stakeholders in clinical trials through open communication. Communicating culturally appropriate to the people being interacted with promotes trust. Based on the study’s findings, researchers may explore designing a culturally inclusive research competency curriculum to teach minority groups the value of contributing to clinical research. This entails ensuring that all research-related materials (such as recruiting materials, informed consent forms, etc.) are created to foster a transparent knowledge of the research.
Additionally, future communication with clinical research personnel should foster openness and address existing communication difficulties. In addition, it is essential to emphasize the advantages of minority participation in clinical trials and research. These encompass obtaining access to skilled medical treatment, acquiring knowledge about specific illnesses, and actively participating in their well-being (Allison et al., 2022). The plan of action is built on solutions well received by all parties involved, so it has a strong probability of succeeding. In this approach, the proposed strategies may increase diversity in the clinical research workforce while improving access and reducing participant strain.
Future Directions
This study unravels the immense possibilities of community-based clinical trial locations. The prevailing environment for clinical studies relies on private pharmaceutical corporations and university researchers to prepare and equip clinical research locations for specific studies. These diverse locations have varying degrees of capacity and connectedness to the community, and the investigation’s framework typically determines their selection. On the contrary, dedicated funding for a hub of clinical research sites in marginalized areas could eventually build a strong infrastructure to increase clinical research personnel diversity. The initiative emphasizes the significance of long-term partnerships and community investment: It is essential to establish long-lasting partnerships based on a common commitment to improving health equality in the selected locations. These partnerships must be developed in advance of any prospective clinical study. Stakeholders in a community-based medical research network should contribute to the community’s improvement beyond their own goals.
Increased collaboration with stakeholders in the clinical research network is on the horizon. Contributors in these alliances will come from a wide range of sectors, including patient groups, communities, universities, NGOs, government agencies, and businesses. The end goal is to set up a system for conducting clinical trials that actively involves all people affected by a particular health issue. Ultimately, it is expected that the identified research gaps will be addressed. Nonetheless, it is uncertain if future studies will determine whether training ultimately results in changes in clinical research personnel’s attitudes about the significance of supporting and enrolling minority populations in clinical trials. Since changes in perspective are difficult to measure, even if such research were undertaken, it may not provide useful results.
References
Allison, K., Patel, D., & Kaur, R. (2022). Assessing Multiple Factors Affecting Minority Participation in Clinical Trials: Development of the Clinical Trials Participation Barriers Survey. Cureus, 14(4), e24424. Web.
Aysola, J., Harris, D., Huo, H., Wright, C. S., & Higginbotham, E. (2018). Measuring organizational cultural competence to promote diversity in academic healthcare organizations. Health Equity, 2(1), 316–320. Web.
Zini, M., & Banfi, G. (2021). A Narrative Literature Review of Bias in Collecting Patient Reported Outcomes Measures (PROMs). International journal of environmental research and public health, 18(23), 12445. Web.