Clinical Trial Diversity Helps Progress Health Equity

Every year on May 20, my team and I celebrate Clinical Trials Day. It is a time when we reflect on our work as members of the clinical research community and recognize what has been accomplished because of clinical trials, the numerous professionals behind them, and, of course, the participants and volunteers who help advance breakthroughs. This year, my thoughts are centered especially around how ensuring diversity in clinical studies can level the healthcare landscape for many people.

A focus on clinical trial diversity has not been new for Pfizer or the industry, but the disproportionate impact of COVID on historically underrepresented communities in trials put a new spotlight on the need for diversity in trials, because historically, clinical trials have either disadvantaged racial and ethnic minorities, or underrepresented them. In either case, the end result is that minorities have not had much of a say in the development of new medicines and vaccines. This is counterproductive—race, ethnicity, age, and gender can all impact how different people respond?to the same medicine or vaccine, so it is essential that clinical studies reflect the diversity of the potential recipient population.

For example, the death rate for Black Americans with multiple myeloma is roughly twice as high as that of White Americans, according to the American Society of Clinical Oncology. Yet, an FDA analysis of multiple myeloma-focused clinical trials found that the median enrollment percentage of Black Americans was just 4.5%. Here’s another example. Asian Americans are twice as likely to be diagnosed and die from stomach and liver cancer than white Americans. Despite this reality, a portfolio analysis of grants funded by the National Cancer Institute’s Division of Cancer Control and Population Sciences showed a very limited number of studies focused on Asian Americans, with none at the time addressing the causes of cancer.

Asian Americans represent only 1% of clinical trial participants despite making up nearly 6% of the U.S. Census population. Similarly, Black Americans are roughly 13% of the U.S. population but represent only 5% of clinical trial participants across all trials, and Latinos represent 19% of the nation’s population but only 6% participate in clinical trials.

A lack of clinical trial diversity also means that members of underrepresented communities are not able to access the potential health benefits of a clinical trial, which can perpetuate or further widen existing health gaps. It’s clear that clinical trial diversity can be a significant influence on broader healthcare patterns, and it should be a priority for any organization looking to develop a new medicine or vaccine. It is the goalpost for my development team—and here is how we aim for the net.

Our Benchmark Analysis

In 2021, Pfizer did something bold: we published a landmark, 10-year retrospective analysis of the ethnic, racial, age, and gender diversity in our US clinical trials, encompassing data from 2011–2020—and we published it online for all the world to see.

There was considerable trepidation when we began our study. What if the results were unfavorable? Were we opening ourselves up to criticism? However, our commitment to patients, to ensuring that we did everything we could to make them feel represented, included and confident about our medicines and vaccines, fueled our desire to understand our baseline of diversity in our clinical trials and to ensure that we close any gaps in representation.

Our analysis demonstrated that overall trial participation of Black or African American individuals was at the US census level (14.3% vs 13.4%) and female participation was also at the US census level (51.1% vs 50.8%). However, participation of Hispanic or Latino individuals was below US census (15.9% vs 18.5%). We also examined the percentage of trials that achieved racial and ethnic distribution levels at or above US census levels. Participant levels above census were achieved in 56.1% of Pfizer trials for Black or African American participants, 51.4% of trials for White participants, 16.0% of trials for Asian participants, 14.2% of trials for Native Hawaiian and Pacific Islander participants, 8.5% of trials for American Indian and Alaska Native participants, and 52.3% of trials for Hispanic or Latino participants.

We were the first pharmaceutical company to go on the record with our benchmark for clinical trial diversity, but have already seen our methodology serve as a standard for other companies and that is indeed encouraging. With our benchmark in hand, we committed to achieving racially and ethnically diverse participation at or above U.S. census or disease prevalence levels (as appropriate) in all of our clinical trials.

Steps to Achieving Diversity

For us clinical trial diversity is a matter of not only good science but also equity – one of our core values here at Pfizer. So we’ve committed to designing all of our clinical trials so that enrollment reflects the racial and ethnic diversity of the countries where we conduct these trials and the epidemiology of the diseases we intend to treat or prevent. We are also working to ensure there is increased inclusion of women, the LGBTQ+ community, and persons with disabilities who are also underrepresented in research. There is much complexity to navigate, but this is the only way we can accurately understand the state of healthcare for our patients and address gaps in access.

There are numerous practical and informational barriers to clinical trial participation—particularly for members of underrepresented communities. That is why we are being very intentional about ensuring diversity in all our trials across all demographics and are taking decisive steps to achieve these goals:

• Embedding the importance of diversity in clinical trials into our company’s culture by investing in training colleagues who manage clinical trial operations, including building an epidemiology library and implementing an interactive dashboard that enables real time diversity enrollment analytics. We set metrics and hold ourselves accountable. Our teams recently published our framework for setting diversity targets for trials in Contemporary Clinical Trials. Our goal is to continue to share our knowledge in the hopes that others can adapt our learnings as well. No single company or organization will solve the challenges of ensuring diversity. It will take all of us.
• Evolving how we partner with clinical trial sites by implementing a data-driven approach to choosing clinical trial sites in communities that represent a diverse pool of potential participants and helping to expand the pool of clinical investigators so that they also reflect the diversity of our patients. For example, we have partnered with the Columbia University Irving Medical Center to establish the Columbia-Pfizer Clinical Trials Diversity Initiative to reduce health disparities by increasing the participation of underrepresented minorities in clinical trials and enhancing the diversity of clinical researchers.
• Building awareness and trust in diverse communities by providing culturally relevant co-created and linguistically appropriate materials that are easy to read and understand. For example, we’ve worked with Tigerlily Foundation to create the HEAL (Health Equity Advocacy and Leadership) workshops to better understand the breast cancer journey for women of color and foster inclusivity in clinical trials. We also launched https://www.pfizerclinicaltrials.com/ as a searchable destination for anyone interested in learning more about all ongoing Pfizer clinical trials.
• Making participation easier for trial participants by introducing flexibility in trial design and participation through the use of digital tools, remote monitoring, mobile health units, retail partnerships and other innovative ways. I’m pleased to say that more than half of all our clinical trials now offer some kind of decentralized element, reducing the burden of participation for those who may not have otherwise.

The road to health equity might be long and challenging, but my team’s commitment to clinical trial diversity is one way to ensure we keep moving the ball in the right direction.