In clinical research, diversity, equity, and inclusion (DEI) is becoming increasingly recognized as essential for ensuring medical interventions are effective and safe for all populations. Historically, clinical trials have lacked representation from marginalized communities, leading to gaps in understanding how treatments work across different demographic groups.
Why DEI Matters in Clinical Trials
DEI in clinical research is crucial because it ensures clinical trial outcomes apply to a wider population. According to the chief medical lead at a company focused on increasing diversity in clinical research, the absence of diverse participants in drug development can results in less effective treatments or even unsafe for underrepresented groups. Differences in genetics, biology, and metabolism can affect how drugs work for different populations. If clinical trials don’t include these groups, the resulting data may not account for side effects or variations in effectiveness across diverse populations.
For instance, while Black, Native American, Hispanic, and Pacific Islander communities make up roughly 40% of the U.S. population, they represent less than 5% of participants in clinical trials. Without adequate representation, the healthcare system risks developing treatments that may not be optimal for these communities.
Shifting the Landscape: From Exclusion to Inclusion
Fortunately, the clinical research community is beginning to address these disparities. As noted by the medical lead, there is a growing realization among research sponsors, regulatory bodies, and healthcare providers that a lack of diversity in clinical trials is unacceptable. Regulatory authorities like the Food and Drug Administration (FDA) have introduced measures requiring diversity plans for phase III clinical trials, pushing for greater accountability and inclusion in research.
Historically, mistrust in medical research, especially among communities of color, stems from unethical practices like the Tuskegee Study. In response, many institutions adopted protective measures that, while well-meaning, often resulted in further exclusion of these populations from research. Today, the focus is shifting towards creating more inclusive processes protecting participants while still allowing their participation.
Building Trust: Cognitive and Affective Approaches
Rebuilding trust with underrepresented communities is crucial to improving DEI in clinical research. The medical lead highlights two types of trust—cognitive and affective—essential to this process. Cognitive trust is built on knowledge, expertise, and credentials, while affective trust stems from emotional connection and care. Historically, the research community has relied too heavily on cognitive trust, assuming expertise alone would convince people to participate.
However, affective trust is equally important. This type of trust is built by showing genuine care and interest in communities long before asking them to participate in research. Engaging with communities through educational outreach, partnerships with local leaders, and addressing historical wrongs fosters a deeper level of trust. By combining cognitive and affective trust, researchers can build lasting relationships, making communities more open to joining clinical trials.
Recruitment and Site Selection: Expanding Access to Clinical Trials
Improving DEI in clinical research requires rethinking how and where clinical trials are conducted. Historically, research sponsors have focused on large, well-established research centers that may not be accessible to diverse populations. According to the medical lead, this approach can limit participation from individuals who receive care at smaller community clinics.
To address this, research sponsors need to engage underrepresented communities early in the planning process. This involves identifying these communities before trials begin and building relationships through educational programs, partnerships with local healthcare providers, and more inclusive site selection. Sponsors may also need to invest in the infrastructure of smaller clinics to ensure they can participate in research effectively.
Leveraging Technology for Broader Reach
Technology also offers powerful tools to advance DEI in clinical research. Digital platforms, like those developed by the company mentioned earlier, combine online engagement with traditional community outreach to connect with individuals who may not be aware of research opportunities. These platforms provide education on health issues, research participation, and tailored information for underrepresented populations. Using artificial intelligence (AI) and machine learning (ML), researchers can analyze demographic data to refine outreach and better engage diverse communities.
Achieving DEI in clinical research is not just an ethical responsibility, but a practical necessity to ensure medical advancements benefit everyone. Research sponsors, regulators, healthcare providers, and communities must work together to build trust, improve recruitment strategies, and ensure clinical trials are accessible and representative. By integrating DEI into all phases of clinical research, we can take meaningful steps toward health equity for all.
