The American Medical Association (AMA) recently put out a statement regarding the limited use of Body Mass Index (BMI) in assessing overall health risk in patients.  This was related to the AMA’s Council on Science and Public Health report, which evaluated the limitations of using BMI especially in patients of different races and ethnicities. The AMA is calling for the need to educate healthcare providers (HCPs) on these differences.  For example, in the Black population, BMI has been used historically as a racist tool of exclusion. Recent research has uncovered that there are many social determinants of BMI such as poverty, racially segregated neighborhoods and generational trauma.  This raises the question for the pharmaceutical industry as to what changes need to take place to improve diversity in clinical trials.  

Without a doubt, clinical trials play a pivotal role in advancing medical knowledge and developing new treatments for various health conditions. However, for far too long, the lack of diversity in clinical trial participants has been a significant concern. Historically, clinical trials have predominantly included participants from specific demographic groups, leading to limited generalizability of research findings and potential disparities in healthcare outcomes. Recognizing the importance of diversity in clinical trial design is crucial to ensuring equitable and effective healthcare for all populations. In this blog post, we will explore the significance of diversity in clinical trials and discuss the benefits of inclusive trial design.

Understanding Real-World Impact:

Diversity in clinical trial design allows researchers to examine the impact of medical interventions across diverse populations. People from different ethnicities, races, ages, genders, and socioeconomic backgrounds can exhibit distinct responses to treatments due to genetic variations, environmental factors, and cultural differences. By including a diverse range of participants, researchers can gain a deeper understanding of the real-world efficacy and safety profiles of medications, thereby enabling more informed decision-making in healthcare.

Addressing Health Disparities:

Health disparities, often linked to socioeconomic status, race, or ethnicity, have persisted in medical research and clinical practice. Inclusive clinical trial design offers an opportunity to address these disparities. By actively recruiting individuals from underrepresented populations, researchers can gather valuable data to inform personalized treatment approaches, reduce health disparities, and improve healthcare outcomes for marginalized communities. Additionally, inclusivity in clinical trials fosters trust and enhances patient engagement, leading to better adherence and long-term health management.

Ensuring Safety and Efficacy for All:

Medications and treatments can affect individuals differently based on various factors, including genetic variations. By diversifying clinical trial populations, researchers can identify potential differences in treatment responses among different groups. For instance, certain medications may have varying effectiveness or side effects based on a person's genetic background. By including diverse participants, researchers can identify these variations, leading to the development of personalized medicine and safer, more effective treatments for everyone.

Improving Generalizability of Research Findings:

Clinical trials serve as the foundation for evidence-based medicine and healthcare guidelines. However, if trial participants are not representative of the broader population, the generalizability of research findings becomes limited. Exclusion of certain groups may result in the underrepresentation of specific health conditions or age groups, leading to biased recommendations. Inclusive clinical trial design ensures that findings are applicable to a broader range of patients, enabling healthcare professionals to make informed decisions that cater to the needs of diverse patient populations.

Ethical Imperative:

Ensuring diversity in clinical trial design is not only a scientific and medical necessity but also an ethical imperative. All individuals, regardless of their background, should have equal access to the benefits and opportunities arising from medical research. By actively including diverse populations, we promote justice, fairness, and respect for human rights in the realm of healthcare. Inclusivity in clinical trials is an essential step towards dismantling systemic barriers and achieving health equity.

The Role of Medical Affairs and Medical Science Liaisons

Medical Science liaisons (MSLs) and medical affairs professionals as a whole play a key role in ensuring that clinical trials are representative of the overall population.  For example, medical affairs leaders are often involved in choosing clinical trial sites (either within the organization or working with a clinical research organization (CRO).  Additionally, medical science liaisons are increasingly focused on group accounts versus individual key opinion leaders (KOLs) and have an influence on which clinical trial sites are chosen to be part of research.  Ensuring that MSLs and medical affairs professionals have a clear and standardized approach to clinical trial design and protocol is of paramount importance to ensure health equity for all.  One of the ways to accomplish this is to establish standardized competencies through board certification of medical affairs professionals.  This is one of the reasons we are seeing an increasing number of medical affairs organizations board certifying their medical affairs/MSL teams as Board Certified Medical Affairs Specialists (BCMAS).  Ensuring that global practices are harmonized also minimizes risk and improves compliance for these organizations.  

Conclusion:

The importance of diversity in clinical trial design cannot be overstated. Inclusive research practices are fundamental to advancing medical knowledge, improving healthcare outcomes, and addressing health disparities. By embracing diversity, researchers can generate robust evidence, develop personalized treatments, and ensure equitable healthcare for all individuals. Moving forward, it is crucial for the scientific community, healthcare providers, and policymakers to actively promote and prioritize diversity in clinical trials to pave the way for a more inclusive and effective healthcare system.  Medical affairs and MSL professionals must continue to engage this wide array of stakeholders to ensure that everyone’s voice is heard.