Racial and ethnic minorities now make up over 42% of the U.S. population. However, the statistics are alarming when we look at corresponding racial and ethnic representation in clinical trials. According to Clinical Research Pathways, only 5% of clinical trial participants are Black, despite being 13.4% of the U.S population. The statistics are even worse for Hispanic/Latino people who make up 18.1% of the population but only 1% of clinical trial participants.
The lack of racial and ethnic diversity in clinical trials has risen to the forefront of many health equity discussions, sparked by the culmination of COVID and the racial justice movement. In addition, the FDA has given pharma repeated notice that the lack of diversity in clinical trials represents a significant health concern. The agency has started making examples by not granting FDA drug approval for trials without adequate racial and ethnic representation.
Almost every major pharmaceutical company, including GSK, Merck, AstraZeneca, Sanofi, Roche, AbbVie, Johnson & Johnson, Pfizer, Novartis, Bristol-Myers Squibb, has placed increased emphasis on the inclusion of racial and ethnic populations in their clinical trials. However, there has not been an organized effort by the pharmaceutical industry to standardize how we assess the actual empirical outcomes of clinical trial diversity efforts.
Benefits of a Standardized Industry Metric for Clinical Trial Diversity
A familiar adage says, “what gets measured gets done.” Establishing a standardized metric to measure racial and ethnic clinical trial diversity provides several benefits. A standardized metric is a necessary step to benchmark the current state of the industry. It helps answer the question, “how are we performing today compared to 5 years ago?” A standardized industry metric allows us to take a closer look at the major pharmaceutical companies that sponsor most drugs we consume. How well are they performing in terms of diversity and inclusion in their sponsored clinical trials? We would have a tool to systematically categorize, compare, and even rank major pharma companies according to an empirical assessment of their clinical trial diversity and inclusion.
We might find that certain pharmaceutical companies perform extremely well or extremely poorly with certain racial and ethnic populations (e.g., Blacks compared to Asians). We might see that pharmaceutical companies with drugs that target diseases with a higher prevalence in certain racial and ethnic populations (e.g., diabetes, cancer, asthma) have historically underrepresented the populations they should have oversampled.
The benefits of a standardized industry metric for clinical trial diversity extend to consumers and patients as well. Savvy consumers and patients are increasingly evaluating the safety and efficacy of the drugs they are prescribed. What if a Black woman with diabetes had a way to increase her confidence that the company making her insulin drug ranked high in ensuring their drugs worked for the same for Black populations. In a crowded insulin drug market, a high clinical trial diversity ranking that produces greater consumer confidence, particularly within communities of color, would prove a competitive advantage for a pharma company.
Computing a Standardized Industry Metric for Clinical Trial Diversity
How might such a standardized metric be developed? A straightforward approach may be easier than we think. The FDA Drug Trials Snapshots program began in 2015 as part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide concise information about the racial and ethnic mix of those who participated in the clinical trials that supported the FDA approval.
- Export the racial and ethnic clinical trial participant data from each drug’s product page
- Index the racial and ethnic clinical trial participant data against U.S. Census racial and ethnic population data
- Adjust the index for disease states with different prevalence across racial and ethnic populations. For example, certain cancers and cardiovascular diseases have a higher prevalence in Blacks, so we would expect to see a higher number of Blacks in participant data for these drug trials
- Compute a standardized metric for each drug based on the adjusted index
- Generate a Clinical Trial Diversity Score for each pharmaceutical company based on a composite of the company’s sponsored drug metrics.
- Make the Clinical Trial Diversity Score and associated data publicly available
The Time is Now
Standardized industry metrics are all around us. The airline industry measures on-time departures and arrivals. The healthcare industry measures patient satisfaction. Metrics create a way to establish benchmarks, assess performance, and make critical adjustments. They provide an opportunity to evaluate performance across companies within the same industry. They also provide stakeholders with a clear way to assess how well companies are performing on the key areas that matter the most. It is time for the pharmaceutical industry to make a significant step toward health equity by adopting a standardized industry metric to assess clinical trial diversity.
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About Acclinate™
Acclinate™ is a Birmingham-based, digital health company helping pharmaceutical companies and healthcare organizations access and engage communities of color so research is more inclusive.
