Clinical trials are the foundation of medical innovation, shaping the future of healthcare by determining how safe and effective new treatments are. However, the lack of diversity in clinical research remains a persistent issue. Historically, women, seniors, racial and ethnic minorities, and individuals from low-income backgrounds have been sidelined in trials, raising concerns about whether medical advancements truly serve everyone. Without diverse participation, trial results risk being skewed, making treatments less effective for underrepresented groups.
Before fixing the problem, we need to acknowledge an uncomfortable truth: the existing regulatory framework has not done enough. The pandemic offered a glimpse of what’s possible when urgency demands inclusivity. Now, the challenge is to make these improvements permanent.
The Current Landscape of Clinical Trial Diversity
Diversity in clinical trials is not a new problem—it’s an old flaw that remains unresolved. A 2020 FDA study revealed that 60% of clinical trial participants in the U.S. were white, while Black and Hispanic participants accounted for only 8% and 11%, respectively, despite their significant representation in the general population.
Why does this happen?
For many minority communities, participating in clinical trials isn’t just a choice—it’s often an uphill battle. Research centers are usually located in well-funded urban areas, making it difficult for people in rural or low-income neighborhoods to access them. Even when trials are available, historical mistreatment, such as the infamous Tuskegee syphilis study, has left a deep sense of mistrust in the medical system. Many people hesitate to sign up, fearing they’ll be treated unfairly or exploited. On top of that, the financial strain can be overwhelming. Taking time off work, traveling long distances, or covering medical costs related to the trial is simply not feasible for many. While existing regulations emphasize the need for diversity, they fall short of making it a non-negotiable standard. The big question now is: how can policies evolve to turn diversity from an afterthought into a priority?
Policy and Regulatory Changes to Improve Diversity
1. Mandating Diversity Reporting
Transparency drives accountability. Regulatory agencies such as the FDA and EMA should require trial sponsors to disclose participant demographics, making diversity a fundamental aspect of drug approval. The NIH’s Inclusion Across the Lifespan Policy already mandates age-related diversity reporting—this model should be expanded to racial, ethnic, and socioeconomic factors (NIH).
2. Incentivizing Inclusive Practices
Governments can introduce tax benefits or grant funding to pharmaceutical companies that meet diversity benchmarks. A similar approach was used to fast-track COVID-19 vaccine development, where diverse participation was a critical factor for approval. Expanding such incentives across all trials could encourage industry-wide compliance.
3. Decentralizing Clinical Trials
Decentralized Clinical Trials (DCTs) leverage telemedicine, home visits, and local healthcare facilities to make participation more accessible. During the COVID-19 crisis, Moderna used remote monitoring and community-based recruitment to improve diversity in its vaccine trials (Moderna). Encouraging similar models for future research would remove logistical barriers that exclude underserved populations.
4. Building Trust Through Community Partnerships
Regulations should require pharmaceutical companies to work with local organizations, faith-based groups, and minority healthcare providers to increase awareness and engagement. South Asian Heart Center in California is an example of a community-based approach to tackling health disparities through research participation (Stanford). Funding initiatives to train minority physicians as trial investigators would further close the trust gap.
5. Addressing Economic Barriers
Policies should mandate compensation for travel, childcare, and lost wages to remove financial obstacles to participation. The UK’s National Institute for Health Research (NIHR) offers patient reimbursement schemes—an approach that could be adapted for the U.S. healthcare system.
6. Integrating Technology for Broader Reach
AI and machine learning can identify recruitment gaps and predict underrepresented populations, making trial outreach more targeted. However, regulations must ensure these tools do not reinforce biases. The FDA’s Real-World Evidence Program is already exploring AI’s role in improving clinical research diversity.
Learning from Global Efforts
Diversity in clinical trials isn’t just a U.S. issue—it’s a global challenge. The World Health Organization (WHO) emphasizes the importance of representation from low- and middle-income countries to reflect genetic and environmental differences in treatment response.
While the UK’s Accelerated Access Collaborative integrates public input into trial designs, a more decentralized U.S. healthcare system may require different solutions. Countries like Singapore and Canada have successfully implemented policies that encourage inclusivity through public-private partnerships, regulatory mandates, and financial incentives.
Making Diversity in Trials a Permanent Priority
Diversity in clinical trials isn’t just a moral obligation—it’s a scientific necessity. Without adequate representation, treatments may be ineffective or even harmful for large portions of the population. The COVID-19 pandemic showed that inclusive research is possible under pressure, but maintaining this momentum requires permanent regulatory and policy changes.By enforcing mandatory diversity reporting, incentivizing inclusive trial practices, decentralizing trials, and addressing economic and systemic barriers, governments can ensure that medical breakthroughs benefit everyone—not just a privileged few. The future of medicine must be inclusive, equitable, and representative of the diverse world we live in.