Clinical research often compartmentalizes equity in one bucket, efficiency in another. Representation is framed as a moral imperative. Budget and timelines live in the realm of business operations. But that dichotomy is misleading—and increasingly, a liability.
Health equity isn’t a side initiative. It’s a core driver of clinical trial success.
At Acclinate, we’ve spent years helping sponsors design and implement trials that are both more inclusive and more efficient. And we’ve seen firsthand what the data now supports: trials that are built for representation from the outset are more likely to meet their enrollment goals, retain participants, and deliver generalizable data that clears regulatory review faster.
Here, I want to move beyond the “why” of equitable trials and dig into the “how.” Because health equity doesn’t have to slow you down. In fact, it can be the very thing that keeps you on time, on budget, and ahead of your competitors.
Three Pillars of Trial Efficiency—and How Equity Strengthens Them
Clinical trials are complex undertakings, but their operational success often comes down to three components: recruitment, retention, and regulatory approval. Each one of these pillars is directly impacted—positively or negatively—by how well a trial reflects the real-world population it’s meant to serve.
1. Faster, More Reliable Recruitment
Roughly 80% of clinical trials in the U.S. fail to meet initial enrollment timelines. Why? Because many rely on narrow, status-quo pipelines—academic medical centers, urban hospitals, and populations that have long been over-represented in trials. Moreover, traditional approaches often hinge on biased eligibility criteria, leading to underrepresentation and potential regulatory challenges later down the line (more on this further down).
Expanding outreach to historically underrepresented communities is as much about fairness as it is about opening up access to a broader, untapped population base. When you build relationships through community organizations, provide culturally relevant messaging, and use data to identify overlooked eligible participants, you widen the funnel in meaningful ways.
Case in point: Acclinate’s Alzheimer’s disease initiative.
In partnership with Lightship, we supported a decentralized Alzheimer’s clinical trial by focusing on outreach to African American communities—populations often underrepresented in neurological studies despite facing disproportionate risks. Through our NOWINCLUDED platform and culturally tailored strategies, we increased the number of pre-screened participants by 3.8x in just four months.
Want to read the full story? Get your copy of the case study here.
2. Strong Retention and Protocol Adherence
Recruiting participants is only part of the equation—keeping them engaged through the duration of the study is equally critical. Dropout rates can add weeks or months to your timeline and inflate your cost per participant significantly.
Underrepresented patients are more likely to drop out if they don’t feel seen, heard, or supported. That’s why inclusive engagement strategies—such as using culturally competent communication, employing staff who reflect participant populations, and partnering with trusted community figures—aren’t "nice-to-haves.” They’re essential retention tools.
When participants feel a sense of belonging and clarity about what’s being asked of them, they’re more likely to stay enrolled, comply with protocols, and contribute clean, usable data. The return on investment in trust is tangible—and measurable.
3. Few Regulatory Setbacks and Stronger Approval Pathways
It’s no longer enough to have statistically significant data if it doesn’t apply to the people who will actually be prescribed the drug. Regulatory bodies are increasingly making this clear.
Earlier this year, the FDA’s Oncologic Drugs Advisory Committee denied a major pharma company’s application to expand a cancer drug’s use because the trial data did not adequately reflect U.S. demographics. Specifically, they raised concerns about genetic polymorphisms—common variations in genes like CYP2D6 that are more prevalent in some racial and ethnic groups and affect how medications are metabolized.
In other words: lack of inclusion is both an ethical oversight and a scientific risk.
When your trial isn't sufficiently representative, you’re more likely to face additional data requests, extended review periods, or outright rejection. On the other hand, trials that account for population-level variation in drug response—by including a full spectrum of associated participants who reflect likely users of medications—are better positioned for faster approvals and broader label claims.
The Cost of Exclusion
Let’s talk numbers. The average cost of a single day of delay in bringing a drug to market is estimated between $600,000 and $8 million, depending on the therapeutic area. Recruitment and retention issues are leading drivers of these delays, and both are directly influenced by how inclusive your trial design is.
Even beyond operational costs, there’s the matter of market readiness. A drug that lacks evidence of safety and efficacy across key demographic segments is more likely to face post-approval obstacles, including boxed warnings, restricted indications, or, in rare cases, market withdrawal.
These challenges are both regulatory and reputational. Patients, providers, and payers alike are paying closer attention to how trials are conducted. Sponsors who ignore this shift risk losing trust—and future business.
Equity Is Efficiency: A New Clinical Paradigm
Real-world case studies are growing. In the Alzheimer's trial mentioned earlier, not only did inclusive recruitment improve screening speed—it also improved participant satisfaction, increased community trust in the sponsor, and enhanced the likelihood of long-term engagement for future studies.
These successes compound over time. When you invest in inclusive infrastructure—including diverse site networks, culturally competent staff, and people-first outreach strategies—you create a replicable model that pays dividends trial after trial.
More broadly, you build a brand associated with access, trust, and responsibility—three qualities that should matter just as much to regulators and investors as they do to patients.
Equity and ROI: Aligned From the Start
We’re at the dawn of a new era of clinical development—one that rewards foresight, inclusivity, and scientific rigor. Sponsors that thrive in this new world will be those that stop viewing health equity as a “compliance issue” or an afterthought—and start seeing it for what it is: a competitive differentiator.
Health equity and trial ROI aren’t in conflict. They’re aligned.
The same practices that ensure thorough trials that reflect real-world patients—thoughtful community partnerships, tailored engagement, and inclusive site selection—are the very approaches that support faster launches, better participant retention, and more credible, approvable data.
The future of clinical research is inclusive. It’s also more efficient, more resilient, and more responsive to the needs of all stakeholders—when we design it that way from the start.
Ready for better representation in your clinical trials? Schedule a 1:1 with our team for a front-row view of our solution.
