Key Takeaways and Learnings
When representation is discussed within the context of healthcare, conversations usually go right to how it helps individuals gain access to better treatments. But what's often ignored is just how beneficial it is for research itself. The quality and applicability of medical studies hinge on inclusive clinical trials, ensuring that new treatments are both effective and safe for all appropriate populations — not just a select few.
Despite progress in recognizing the importance of representation in clinical research, gaps remain, potentially leading to less safe and effective treatments, financial losses for pharmaceutical companies, and limited access to innovative medicines, including targeted therapies. This issue is particularly clear in kidney disease research, where Black Americans — who are nearly 4x more likely to develop kidney failure than White Americans — have been historically underrepresented in studies.
Before understanding why representation matters in clinical research, it's first essential to identify the underlying factor in successful medical advancements: high-quality data. And how do studies acquire this reliable information? Through assessing a thorough, diverse sample of participants.
Ultimately, without adequate inclusion of populations from multiple backgrounds, clinical research risks producing treatments that may be less effective — or even harmful — when prescribed to the communities that need them most.
One of the clearest examples of this issue is in kidney disease research. A genetic mutation affecting the APOL1 gene — more common in Black populations with West or Central African ancestry — significantly influences kidney disease risk. Historically, race-based eGFR (estimated glomerular filtration rate) calculations contributed to disparities in diagnosing and treating Black patients with kidney disease.
Recent initiatives have pushed to remove race-based adjustments, and there's also a focus on using precise genetic and biological factors to diagnose kidney disease. However, without concerted efforts to identify the specific, representative population that would benefit most from APOL1-targeted therapies, studies for APOL1-medicated kidney disease may be underdeveloped and their studies delayed.
Additionally, without adequate representation in clinical trials, these therapies may face major setbacks. Notably, lack of inclusion in research doesn't just impact health equity — it can cause obstacles to rolling out new medicine.
For example, marketing teams are often unable to use images of patients of specific races, ethnicities, and other demographics in promotional materials if participants reflecting these populations were not included in pivotal clinical trials. This oversight could affect not only the perception of the treatment's applicability but also its marketability and accessibility.
Camille (Pope) Campbell, PharmD, RPh, Acclinate's Sr. Director, Health Equity and a seasoned pharmaceutical leader, has witnessed these challenges firsthand. During her tenure at a major clinical research company, she worked closely with marketing teams that were asked to revise entire campaigns because the necessary representation was missing from a pivotal study. "We had to change all the marketing pieces, all the branding, because we didn't have the data to support the use of the visuals of Black patients in the assets," Dr. Pope recalls. "Beyond marketing, missing representation may impact physicians' confidence in prescribing the drug, as well as the ability to secure favorable formulary placement, which directly affects a drug's accessibility and profitability."
Beyond ethical considerations, representative clinical trials improve both scientific integrity and business outcomes:
Dr. Campbell also emphasizes the business case for inclusive clinical trials. "If a pharmaceutical company's competition has stronger and more representative data, they may use that as a brand differentiator. Formulary committees and insurance providers are increasingly looking at representation when making placement decisions. If a drug isn't positioned well, prescribers may not write for it as often (or must complete additional steps — like prior authorization paperwork — to prescribe it), which may affect sales," she explains.
To prevent these consequences, the healthcare industry must take proactive steps:
Ensuring representation in clinical trials isn't just about equity — it's about advancing science in ways that benefit everyone. The case of APOL1 research highlights how inclusion benefits both patients and companies developing life-saving treatments, including precision medicines. Without a wide array of participants, we risk developing drugs that may not be safe and effective for everyone, increasing healthcare costs, and limiting access to effective treatments — setting back the healthcare ecosystem at large.
Now, more than ever, industry leaders, researchers, and policymakers must stand firm in their commitment to representation. "This isn't just about making people feel included," says Dr. Campbell. "It's about making sure science works for everyone — and that's something we can't afford to ignore."
When it comes to representation in healthcare, Acclinate is the partner of choice for providers, payers, and pharmaceutical companies. To learn more about our approach, schedule a 1:1 meeting with our team.