In a recent analysis of the global participation in clinical trials, the FDA highlighted the vast difference between the enrolled participants and the global population. Of 292,537 participants in clinical trials globally, 76% were white, 11% were Asian and only 7% were Black.
Clinical trials often face challenges in recruiting and retaining diverse participants who reflect the real-world population that will benefit from the therapies. This lack of diversity can limit the generalizability and applicability of the trial results, and potentially exacerbate health disparities and inequities among different groups of people.
But what do diversity and inclusion mean in clinical trials? And how does it relate to patient centricity, which is another buzzword that has been widely used in the clinical research industry for the past decade?
What is diversity and inclusion in clinical trials?
Historically, clinical trials have often been conducted with a limited pool of participants that is not representative of the overall population. Underrepresented communities, such as racial and ethnic minorities, the elderly, women, and individuals from low-income backgrounds, have been systematically excluded or underrepresented in clinical research. This lack of diversity undermines the generalizability and applicability of research findings, as different population groups may respond differently to treatments due to genetic, physiological, and sociocultural factors.
Recognizing these shortcomings, regulatory authorities and research organizations have begun to advocate for greater diversity in clinical trials. The U.S. Food and Drug Administration (FDA) has taken steps to encourage inclusion and diversity in clinical research, urging sponsors to enroll participants from underrepresented populations. Additionally, the National Institutes of Health (NIH) has implemented policies to promote diversity in biomedical research, aiming to ensure that research participants reflect the diversity of the U.S. population.
What is patient-centricity in clinical trials?
Patient centricity is "putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family." In clinical trials, patient-centricity means involving patients as partners in all aspects of the trial lifecycle, from planning and design to recruitment and retention to dissemination and implementation. Patient centricity also means ensuring that the trial outcomes are meaningful and relevant to patients and that they are communicated in a clear and transparent way.
How are diversity and inclusion related to patient centricity?
Diversity and inclusion are closely related to patient centricity, as they both aim to ensure that clinical trials are aligned with patients’ genuine needs and expectations. Diversity and inclusion can enhance patient centricity by:
- Improving the quality and validity of trial data by increasing the heterogeneity of treatment effects among different subgroups of patients.
- Increasing the trust and confidence of patients in trial participation by addressing their concerns about safety, efficacy, access, affordability, convenience, privacy, and cultural appropriateness.
- Empowering patients to make informed decisions about trial participation by providing them with adequate information, education, support, and feedback.
- Engaging patients as co-creators of trial solutions by soliciting their input, feedback, insights, and perspectives throughout the trial process.
- Advancing health equity and social justice by reducing disparities in health outcomes among different groups of patients.
How can we improve diversity and inclusion in clinical trials?
Improving diversity and inclusion in clinical trials requires a multifaceted approach that involves multiple stakeholders at different levels. Some of the strategies that can be employed include:
- Making trial participation less burdensome for participants by adopting decentralized clinical trial (DCT) capabilities that allow patients to participate remotely or at local sites.
- Improving patient awareness and recruitment by using culturally competent communication channels, materials, messages, and messengers that reach out to diverse communities.
- Expanding access to trial opportunities by leveraging existing networks, partnerships, platforms, registries, databases, advocacy groups, community organizations, and health-care providers that serve diverse populations.
- Rethinking inclusion/exclusion criteria and study designs by minimizing unnecessary restrictions or barriers that may exclude certain groups of patients from trial eligibility or enrollment.
- Evaluating site selection by using benchmarking data to inform site selection, but not define it, and by supporting sites that have the capacity and commitment to recruit and retain diverse participants.
- Continuing to collect and report diversity data by ensuring that sites and trials collect and report demographic and diversity data to help inform future research and regulatory decisions.
Why is clinical trial diversity so crucial?
Firstly, it is a matter of equity and fairness. Every individual, regardless of their race, ethnicity, gender, or socioeconomic status, should have an equal opportunity to participate in and benefit from clinical research. By including diverse populations, clinical trials can address health disparities and ensure that new treatments are effective and safe for everyone.
Secondly, diverse clinical trial populations enhance the robustness and generalizability of research findings. Genetic variations among different ethnic groups can impact the efficacy and safety of medications. Without including diverse populations, researchers risk overlooking potential differences in treatment outcomes.
Furthermore, diverse clinical trial populations contribute to the development of more inclusive healthcare practices. Clinical trials serve as the foundation for evidence-based medicine, guiding treatment decisions for healthcare providers. If the data primarily come from a homogenous group, there is a risk of biased conclusions and recommendations that do not apply to the broader population.
Conclusion
In conclusion, clinical trial diversity is emerging as a critical component of patient centricity. While patient involvement in trial design and decision-making remains crucial, it is equally important to ensure that clinical trials are representative of the diverse patient populations they seek to serve. By promoting diversity in clinical research, we can improve equity in healthcare, enhance the validity of research findings, and develop more inclusive and effective treatments for all individuals.
Diversity and inclusion in clinical trials are not just buzzwords, but essential components of patient centricity. By ensuring that clinical trials reflect and respect the diversity of the real-world population, we can improve the quality and validity of trial data, increase the trust and confidence of patients 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. Diversity and inclusion in clinical trials are not only the right thing to do but also the smart thing to do.
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