Introduction
To obtain scientifically sound conclusions based on the conducted research, it is necessary to take into account the uncertainty of many characteristics of the sample, as well as the limited number of observations. Clinical trials can be conducted for various purposes: the purpose of the study may be a statistical justification of the difference, or, on the contrary, the similarity of groups. The criteria may be the magnitude of some risk (for example, the risk of recurrence of the disease) or the effectiveness of the prescribed therapy method. Moreover, the purpose of the study may be to estimate some numerical indicator (for example, the prevalence of the disease in the population of interest) with a given degree of accuracy. Regardless of the purpose, it is necessary that the study be conducted on a sufficiently wide sample, including also minorities.
Broadening clinical trial outreach to underrepresented populations and advocates and increasing inclusiveness will guarantee the correctness of interpretation of numerical results of statistical methods, and confidence that the purpose of the study will be achieved objectively. The clinical research industry has learned in the past 2 years that a combination of digitalization methods and meeting the social needs of minorities can broaden the clinical trial outreach to underrepresented populations and advocates.
Broadening Clinical Trial Outreach
Over the past 2 years, the clinical research industry has learned some ways that will help broaden clinical trial outreach to underrepresented populations and advocates. Despite the success of involving broad segments of the population in clinical activities with the help of information technology, it is not without drawbacks, the main of which is the digital divide. The use of new technologies when trying to create an inclusive sample for a clinical trial is shown in Figure 1 (Guerra et al., 2022, p. 131).
This concept should be understood as a quantitative gap in access to information technologies, as well as a qualitative one resulting from social inequality (Guerra et al., 2022). Therefore, it is necessary to concentrate efforts on the introduction of information technologies in hospitals serving minorities who are currently beyond the potential opportunity to participate in clinical trials of the digital economy due to poverty, limited opportunities or other factors.
The three categories of mechanisms that make it difficult to participate in a clinical trial may be caused by some factors, such as social identity – race, ethnic group, religion, gender or age. Access to participation in clinical trials can also be negatively affected by social location – a remote or stigmatized place of residence, as well as social status – migrant status, profession, level of education (Guerra et al., 2022). This is because the existence of a digital divide between developed and developing countries, rich and poor citizens, men and women, educated and uneducated, urban and rural residents, as well as between healthy and people with disabilities. To raise the percentage of underrepresented populations and advocates in the clinical sample, it is necessary to eliminate the cause of the problem – the digital divide.
However, in the past 2 years, it was revealed that the involvement of the population in participating in clinical trials with the help of information technology can lead to even greater marginalization of people who find themselves in a difficult life situation due to financial situation, age, health, etc. Based on this, the use of the results of an electronic survey, generalization of the positions of clinical trial forum users should be accompanied by appropriate guarantees of representativeness (Guerra et al., 2022). For example, in addition to an electronic survey, researchers can post questionnaires on paper in local hospitals. Together with the discussion on official websites, information about the conduct of a new test can be organized in public places. Thus, underrepresented populations and advocates will have the opportunity to participate in them, as they will be aware.
Influencing Change in Inclusiveness and Trust for Clinical Research for Hypertension
Men aged 35 to 50 years are most predisposed to the development of hypertension. In women, the risk of hypertension increases significantly after menopause (Deere & Ferdinand, 2020). At this age, older people do not actively use digital technologies, so it is quite difficult to notify them about clinical trials. Moreover, hypertension is often caused by increased psycho-emotional stress and stress, so migrants fall into the risk group and should be included in the sample. Since they are in a state of chronic stress, the increased load leads to wear of the arteries and increases the risk of complications from the heart and blood vessels (Deere & Ferdinand, 2020). Migrants and elderly women are also more likely to be overweight due to the inability to afford high-quality food and due to insufficient physical activity (Guerra et al., 2022). Therefore, researchers should be interested in including these underrepresented populations and advocates in clinical research for hypertension study in order to raise inclusiveness and trust.
However, in addition to the general problem of insufficient digitalization, when attracting this sample, researchers face a specific problem for this sample. This is due to the social role of migrant women in the designated age range: they often prefer to stay at home with their children. Despite the fact that there are many single mothers among them who need funds, they do not agree to clinical research with increased risks in order to be able to continue taking care of children (Guerra et al., 2022). Therefore, in order to attract this population group to clinical trials for hypertension study, not only a special payment regime is needed, but also some other conditions that encourage their participation.
For example, it may be special conditions for the treatment of a child and a mother in a clinic where tests are carried out. The clinic can compensate mothers from migrant families for the cost of medicines or provide them with a discount. It is also possible to organize children’s rooms in the clinic, where children will be supervised while their mothers participate in the trials. An English study group for migrants can be organized at the clinic, which will be free for children whose mothers participate in clinical trials for hypertension (Guerra et al., 2022). Thus, in order to influence Change in Inclusiveness and Trust for Clinical Research, it is necessary to increase the social responsibility of underrepresented populations and advocates to encourage their participation.
Conclusion
Despite significant advances in the involvement of underrepresented populations and advocates in clinical trials, this issue still exists in the medical practice. The solution of this problem can be facilitated by the implementation of measures aimed at involving minorities in participating in research by organizing public platforms for notification not only in electronic format. It is also necessary to appeal not only with material payments, but with various aspects of social assistance that are needed by underrepresented populations and advocates. This can be assistance with children of various types, such as English courses or supervision during clinical trials, or discounts on medicines and free treatment at the clinic conducting the tests. This approach will increase the share of underrepresented populations and advocates in the study sample. Undertaking such steps will lead to influencing change in inclusiveness and trust for clinical research. Therefore, the past two years of the clinical investigate industry have shown that the best method to broaden the outreach of underrepresented populations and advocates is the combination of digitalization methods and meeting the social needs of minorities.
References
Deere, B. P., & Ferdinand, K. C. (2020). Hypertension and race/ethnicity. Current Opinion in Cardiology, 35(4), 342–350.
Guerra, C. E., Fleury, M. E., Byatt, L. P., Lian, T., & Pierce, L. (2022). Strategies to advance equity in cancer clinical trials. Asco Educational Journal, 25(4), 127–137.