Reports that Publicly Financed COVID-19 Trials Continue to Lack Sufficient Diversity

Reports that Publicly Financed COVID-19 Trials Continue to Lack Sufficient Diversity

It’s not a secret that it’s difficult to enroll people of color and other “underrepresented” populations in clinical trials. TrialSite has published on this subject numerous times and even commissioned a survey of African Americans and clinical trials in southeastern Texas. With the onset of COVID-19, communities of color have been hit especially hard (along with elderly and other vulnerable groups). In some cases, Black populations have experienced far higher death rates. TrialSite has observed discussions of diversity and calls for diversity from sites across the U.S. ACTIV, the National Institutes of Health (NIH) led group that screens and evaluates all studies deemed acceptable for COVID-19 financing, has been a big promoter of diversity in COVID-19 trials, yet having beyond minuscule diversity among its own leadership ranks. Now, STAT writers Adam Feuerstein, Damian Garde, and Rebecca Robbins suggest collectively COVID-19 vaccine clinical trials in the United States are failing to enroll diverse populations. That is, those signing up don’t accurately reflect the demographics of the society at large.

The STAT, probably the most influential pharma and research news outlet in the country, calls out the problems based on inputs from a University of California, San Francisco oncologist named Hala Borno who has been studying this topic and shared findings on a recent STAT podcast called “The Readout LOUD.”

According to Borno, of all the studies they reviewed (50% randomized trials and 50% observational or so-called “real world”), about 33% of the studies reported no data concerning race or ethnicity. They report one study didn’t even bother to include race as a demographic category. They observed that in all studies, if one factors in “burden of disease,” then Black communities are underrepresented in the studies. Borno went on to tell the STAT team that it was outrageous that investigators are not uniformly collecting or reporting on this critical data in some cases, despite the known risks. Based on the STAT story, it was hard to know the current participation rates as little data was made available.

Structural & Agency Problems

Efforts to diversity clinical trial participation will, for the most part, continue to fail. Although there are admirable efforts and some of the NIAID studies recruited more African Americans than were represented as a percentage in the population as a whole, a number of structural and systematic challenges get in the way of a different reality.

As the STAT writers reported, in 1993, the 1993 NIH Revitalization Act (Act) attempted to mandate the inclusion of women and minorities in federally funded clinical trials. There is no real way to materialize this transformation. It’s more of a “feel good” rule. Of course, mindfulness in study design and data collection necessitates the collection of ethnic and racial data. This is just a start to get a better handle on the overall problem. But let’s think about it, its almost been 30 years since the 1993 Act. This is pathetic.

TrialSite had to be, unfortunately, hard on the ACTIV leadership because, to a great extent, this is where the problem lies. If the entire top-down, decision-making hierarchy, and connected professional social networks as well as associated divisions, departments, institutional power, and collaborative ecosystems are built upon legacy demographic dynamics, that system recreates itself over and over again over time. This is why nearly 30 years after the 1993 Act, the discussion is like the proverbial broken record; it just keeps on going.

Moreover, in the private sector industry, sponsors seek diverse trial participation, especially if it benefits their ultimately commercializing aims. However, in the private sector, there is rarely the luxury or incentive to go out, take more time, spend more money, and evangelize the benefits of studies to minority groups on a consistent basis. Why? Because time is money. As it is, they (industry sponsors) find many sites frequently late with recruitment objectives; hence if anything, there is pressure to go where patients can be found the most expeditiously. Moreover, clinical operations biopharma executives often have their bonuses pegged to fast site activation, study startup, and key conduct milestones. Hence protocols often are designed with an almost subconscious and implied bias aimed to, on the one hand, expedite patient recruitment yet, on the other hand, cover the proverbial rear-end (hence onerous exclusion criteria).

TrialSite leaves the reader with the following quote attributed to Einstein (but probably not from him): “The definition of insanity is doing the same thing over and over again expecting a different result.”

Call to Action: Read the TrialSite survey and think about ways to transform health care institutions so that they are not only more inclusive for Blacks, Latinos, and Native Americans, for example, but also for Anglo/White groups that may be underrepresented, from rural populations to those that don’t have high incomes or health care access in the form of health insurance. Follow the link to STAT. Also, check out their Readout LOUD.