Contributed Commentary by Radha Mawrie

July 30, 2021 | The recent Pfizer ad was impossible to miss: A picture of a Black woman with the words “Being represented matters in clinical research” makes the clear point that has been overlooked for decades and brought to light, especially during COVID-19.

Black or African-American non-Hispanic individuals were 2.8 times more likely to be hospitalized and 1.9 times more likely to die from COVID-19 compared to White individuals. The risk was 2.8 and 2.3 times higher, respectively, for Hispanic or Latinx individuals.

According to the CDC: “Race and ethnicity are risk markers for other underlying conditions that affect health, including socioeconomic status, access to healthcare, and exposure to the virus related to occupation, e.g., frontline, essential, and critical infrastructure workers.”

Surely there are signs that the impact of recruiting people of color in COVID trials will carry over to other disease states. The diversity conversation, however, has been just talk for a long time. It’s great that study results are being reported with demographic data about race and ethnicity, but it’s still up to the individual pharma company whether it wants to report diversity or not. This is not the path toward meaningful change.

Realizing this, Pfizer did not stop at an ad campaign. In late May, the company released a decade of clinical trial diversity data, benchmarking itself on this most important and timely issue. Progress can’t be made until pharma knows where it starts.

Because of recent developments, racial, ethnic, age, gender identity, and even socioeconomic diversity, globally are now within reach. Before touching on pathways to solutions, it’s important to know why clinical trials have failed when it comes to diversity.

The Many Reasons Diversity Issues Persist

What exactly do we mean when we say there’s a diversity problem in clinical trials? It starts with a demographic imbalance: Latinx and African-Americans make up 18% and 14% of the U.S. population, respectively. However, they represent just 1% and 5% of clinical trial participants, respectively. There are several reasons why this issue remains unsolved.

Mistrust is arguably the leading and most deeply rooted cause of the lack of clinical trial diversity, with unfortunately many examples of past medical mistreatment from the slavery era to the Tuskegee experiment to COVID. Additionally, there are prohibitive costs often associated with participating in clinical trials, both direct (imaging, supporting medications) and indirect (travel, childcare), that may go uncovered by insurance.

The advancement of real-world data (RWD) in clinical trials, bolstered by its successful use in COVID-19 vaccine development via Operation Warp Speed, has led to better and faster drug development. However, because electronic health records (EHRs) don’t consistently capture race or ethnicity information, it is not useful in creating appropriately diverse patient pools. The EHR issue is a larger one and is said to require a major overhaul that incentivizes outcomes by rewarding EHR providers for the “proactive management of health” rather than merely providing more services.

Gender diversity has its own shortcomings. Some studies have found that women experience side effects at rates almost twice as high as men in some cases. Recent increases in women participating in clinical trials likely have more to do with the drugs being specifically geared toward women than targeted diversity. Increasingly, non-binary and transgender populations are winning hard-fought battles for inclusion, and considering how they are currently excluded from most healthcare data, clinical trials remain an area for improvement. Capturing data regarding the participation of non-binary and gender-fluid populations perhaps needs to start with inclusion criteria being framed not just as male/female.

Many therapeutic areas require clinical trial protocols with exclusion/inclusion criteria that not only eliminate conditions but also eliminate entire communities. Kidney disease is a common exclusion in cancer trials that is primarily found in Black communities because they have higher rates of diabetes. HIV is another exclusion common in cancer trials that eliminates certain communities based on race/ethnicity. Because trial design is often templative from one study to another, people of color are often unable to access these cancer trials.

Keys for Meaningful Change Around Diversity

The pandemic and Operation Warp Speed have taught us that heightened awareness can drive long-needed change in pharma. The rollout of industry guidelines from the FDA and PHRMA was a start, but more of the same chatter that has led nowhere.

Pfizer’s recent data release sets a new model for self-benchmarking and demonstrates ownership of the issue. It remains to be seen who will follow Pfizer’s lead, but in the meantime, the recent release of data sends a message to others that real change starts by tracking diversity consistently. Better awareness through communication and partnerships and the improved access provided by decentralized trials—more prevalent with the rise of patient-focused approaches industry-wide—can help remove these barriers.

Digital outreach has the power to truly level the playing field when it comes to diverse populations and demographics. Social channels, for example, enable targeted messaging to different communities and allow patients the opportunity to connect with a clinical trial in ways they previously could not. Using multiple digital channels and social networks that increasingly include video are part of a growing trend, and more sophisticated efforts are on the horizon, like the SWOG Cancer Research Network’s proposed social media toolkit for clinical trial outreach.

While diversity efforts in the U.S. are rightly focused on people of color because of the combination of COVID-19 and ongoing demonstrations for racial justice in the last year, globally the issue is broader. There’s no reason socioeconomic representation, through the use of RWD, can’t be ensured, as well.

Whenever possible, all stakeholders in clinical trials should be thinking about inclusion. While it’s true most protocols specify initial inclusions as male or female, it’s possible to accommodate individuals describing their own gender and whether they identify as non-binary and gender-fluid individuals. Blind spots in EHR data along ethnic/racial lines can and should be addressed. It’s simply a matter of who will make the first move.

The time is now to get diversity right in clinical trials, with recent industry proclamations and plenty of recent research indicating the benefits of more diverse trials. Increasing awareness, digital outreach, and broadening diversity tactics to ensure racial, ethnic, gender, and socioeconomic representation globally are the most prudent ways the industry can respond to a rise in diversity and better outcomes for more people.

Radha Mawrie, VP of Trial Strategy at Trialbee, has 15 years of experience with leadership positions in digital patient enrollment, real-world data, and HCP marketing. Prior to Trialbee, she built and coached a best-in-class patient research function at Acurian (PPD) with data-driven feasibility and recruitment strategy capabilities focused globally on multiple therapeutic areas. At IMS Health (IQVIA), she was the innovation lead for global oncology data and analytics for life sciences clients, steered the global oncology thought leadership initiatives and defined the real-world data capabilities by integrating diverse assets into a cohesive solution. At Reed Elsevier, she drove the digital transformation of content for HCPs with a sharp focus on clinical information use at point-of-care. She can be reached at radha@trialbee.com.