Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research

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Clinical research seeks to provide information that may be used to cure illnesses and improve human health. In an ideal world, the advantages of research would be spread evenly throughout all social groups, regardless of race, age, gender, or ethnicity. This provides compelling reasons for the research community (e.g., sponsors, investigators, and institutional review boards [IRBs]) to increase research participation access. It also pushes the community to understand ways to enhance diversity in clinical trials for traditionally under-represented populations including women, children, cognitively disabled persons, the elderly, and racial and ethnic minorities.

Discovering why Groups are Historically Under-represented in Research

Clinical research has historically failed to effectively involve certain categories of individuals. In certain circumstances, this is because these groups have been identified as vulnerable and in need of protection.
Women and adults of child-bearing potential, for example, have historically been excluded due to worries about the possible effects of an experimental substance on the pregnancy.

Individuals with mental illnesses and those with cognitive impairment have been excluded due to a perceived incapacity to consent for themselves. Likewise, children. The elderly have also been omitted due to concerns about probable co-morbidities and polypharmacy potentially raising study risks or confounding data interpretation.

In other circumstances, the reason for the under-representation of certain populations in research is more complicated. Racial and ethnic minorities have a long history of being used by academics, resulting in high levels of mistrust in the research sector. It should come as no surprise that lower enrollment rates among racial and ethnic minority groups reflect this fact.

Ethical Concerns with Research Under-representation

There are at least two ethical concerns with these disparities.

When specific populations are excluded from the study, it might be difficult to apply the findings to them. For example, just because a medicine is safe or effective in a tightly defined research population does not indicate it is safe or effective in a larger group of patients who may have comorbidities or be on other drugs. Exclusion of these and other groups from research prevents them from partaking in the core advantages of research - breakthroughs in illness diagnosis, treatment, and preventive studies - and fosters longer-term health disparities, with these groups being "left behind" from a public health aspect.

Second, when particular populations are excluded from research, they miss out on the possible direct advantages of research engagement. While the fundamental goal of research is to generate information, research involvement frequently results in access to potential new therapeutics. Enrolling in a research trial of an experimental new medicine may be the best option for many people with illness problems for which there is presently no cure or standard of care. Everyone should have equal and fair access to these possibilities.

Addressing Ethical Issues with Clinical Research Disparities

What can the scientific community do to address these challenges and learn how to increase clinical trial diversity through on-point clinical research monitoring? The first thing to acknowledge is that repairing trust among groups who have been harmed by research will require time, a commitment from the research community to listen to what these groups have to say, and a readiness to take their experiences to heart and allow them to change us. There are no fast cures for the public's skepticism about science.

Although we try to develop trust as a research community, there are things we can do to support the inclusion of underrepresented groups. While they are easy and straightforward tasks, they are frequently neglected and not implemented.

While many of the following items are the responsibility of sponsors and researchers, the role of the IRB should not be neglected. Moreover, empirical research has demonstrated that IRBs perceive themselves to have a role to play in fostering inclusiveness, and good work has been done to provide a roadmap for IRBs' roles in increasing the diversity of clinical research populations.

Here are some practical techniques for increasing clinical trial diversity while addressing ethical concerns:

• Establish meticulous research eligibility criteria without excluding particular populations, such as women and people of childbearing age, children, the mentally ill and cognitively handicapped, non-English speakers, the elderly, and racial and ethnic minorities.

• Use deliberate, protective steps, short of exclusion, to address concerns regarding potentially vulnerable populations participating in research. Contraception measures for women of childbearing potential, legally authorized representatives to agree on behalf of cognitively challenged persons, and intelligently developed eligibility and individual withdrawal requirements for older people with comorbidities are examples of such measures. Clinical research monitoring tools can prove invaluable when mapping out and implementing protective measures.

• Documents should be translated into languages other than English for non-English speakers. This is basic, and the translation expenses are low enough that it is a no-brainer for most sponsors. 

• Provide comprehensive compensation options for out-of-pocket expenditures associated with participation, such as travel and childcare. These costs are among the most significant impediments to research involvement among economically poor communities (which often include, unfortunately, racial and ethnic minorities). Consider paying participants appropriate recompense for their time and the hardships they bear. What constitutes "fair" remuneration will vary based on a variety of circumstances, including the nature of the research and what is expected of participants, the time commitment required, and the local cost of living.

• Members and employees at sponsors, locations, and IRBs should be diverse. This helps the research community to learn from and benefit from historically marginalized perspectives and viewpoints, which may assist under-represented groups in feeling more at ease in research settings. Diversity and inclusion are two of the foremost and most crucial future trends in clinical research.
  These are short-term objectives that can be met. They can help to steer the research community in the correct direction as we work hard to rebuild confidence in society, particularly among historically oppressed and exploited populations.

In summation

Diversity and inclusion in clinical trials are more than simply buzzwords; they are critical components of patient centricity. We can improve the quality and validity of trial data, increase patient trust and confidence in trial participation, empower patients to make informed decisions about trial participation, engage patients as co-creators of trial solutions, and advance health equity and social justice by ensuring that clinical trials reflect and respect the diversity of the real-world population. Diversity and inclusion in clinical studies are not only morally correct, but also prudent.

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Do you want to learn how Octalsoft may help you overcome existing clinical trial problems, speed the discovery of novel therapeutics, and usher in a new age of evidence-based medicine that helps patients of all races, genders, ethnicities, and geographies? Book a demo with us now! You can also have a quick chat with one of our experts by following this Link. We look forward to hearing from you.