Clinical Researcher—April 2021 (Volume 35, Issue 3)
Allison Kalloo, MPH
Newsflash: Minorities—African Americans in particular—over-index in measures of poor health outcomes. By now, you already know that combating a deadly plague has only been exacerbated by persistent disparities in disease prevalence and by the stark and longstanding underrepresentation of communities of color in clinical trials. The fierce urgency to identify effective coronavirus solutions means these inequities may finally be getting the exposure long needed.
Amid our collective despair, tiny celebrations are taking place in honor of silver linings and tipping points. This surreal period in human history confirms for me that there is no better time to dream than in the darkness.
COVID-19’s toll affects us all, but the stark disparities evident through the lens of race reveal that the heaviest losses are among Black, LatinX, and Indigenous Americans—more than twice as high as the rate for Whites and Asians. Massive attention is now focused on getting Black and Brown people to participate in clinical trials in numbers that reflect disproportional disease burden. The world has also been given a primer on the effects of unresolved baggage regarding race and racism and how sociocultural variables reverberate in clinical research.
If we didn’t know any better, one could assume from the global coverage regarding COVID-related disparities that civilization has uncovered a new problem. In reality, the void in diversity, equity, and inclusion (DEI) in research is an old problem. What is unprecedented is the widespread attention.
In truth, the current focus on lack of DEI in clinical trials has brought moments of delirious intoxication. Could it be that industry has awakened to the obligation and opportunity of change for the better? Has industry now developed an appetite for implementation that will be followed by decisive action? You may say I’m a dreamer.
Eternal Vigilance is the Price of DEI
Kindly overlook the fact that I must temper my glee. If my hopefulness is tinged with incredulity, I have my reasons. For all of the potential good that is to come, I am hypervigilant about not allowing this bright spotlight to blind me to the unhealthy patterns of the past. Broken promises and disappointments have left serious adverse events in the form of little burn spots. DEI projects with promise have been whitewashed or underfunded or put off for another time. Industry commitment has in fact been lost to follow-up.
Please understand that the fierce urgency of addressing the racism of a virus also means opening up a secondary vulnerability to grandiose promises. What communities of color are really susceptible to is facing another screenfail by fully engaging our hopes and dreams again to no avail. To truly believe that this moment has gravitas and real staying power, those of us at highest risk for cynicism will need concrete evidence of industry’s commitment to resolving disparities.
I am personally expecting an evolved set of metrics. This time, I am going to need to see the receipts for all of the words. But I’m not the only one.
No doubt, the history of medical apartheid factors largely into African Americans’ hesitance to participate in the very research likely to save lives. Look no further than the data on coronavirus infections and deaths showing an ironic and tragic inverse of the numbers of vaccinations by demographic. One might conclude that marginalized populations are unaware that the Tuskegee Experiment was singularly responsible for the advent of informed consent and heightened patient protections by federal regulation. You ask why we have not come running.
The industry needs help communicating about what vested interest in research really means, and the pandemic is poised to drive the point home. There has to be a reconciliation of these facts with all stakeholders—that when studies do not reflect the diversity of the real world, not only will modern medicine continue to be complicit in perpetuating disparities, but those minorities who categorically refrain from participating in research will be complicit in less than favorable health outcomes and our own demise.
This is no time to sugarcoat the facts. I tell people as often as possible that we simply cannot afford to sit this out. Frankly, we should consider inclusion in clinical research as much a social justice issue as protesting against police brutality.
Practice What You Preach
Make no mistake. My role as disruptor includes being a staunch advocate for patient diversity in clinical trials and actually stepping up to participate. I have been in more than a dozen studies and I am currently participating in the Novavax vaccine trial. But advocating that patients of color take risks—when industry is so risk-averse and has been heretofore unreliable—creates its own anxiety.
These communication challenges inherent to issues of diversity, inclusion, equity, social determinants, historical injustices, and so forth—whether real or imagined—bring about additional obstacles downstream when trust must be negotiated. But here is where we must start: Whether it’s a matter of hiring Black staff, recruiting Black executives, asking Black community members to join your community advisory boards, contracting with Black-owned companies, or asking a member of your patient advocacy group to lend some perspective to publications calling for more diversity in clinical trials, I can guarantee that we all do some form of the following calculus in our heads.
Are you really ready for the truth? Can you handle it? And if you can, will there be tangible evidence of the changes we recommended? And what will be the price for making the establishment uncomfortable or disrupting the status quo?
We—Black and Brown people—are not inspired to believe you when you say that diversity is important to you if you don’t put skin in the game. Making public statements that include the phrase “Black Lives Matter” will fall flat without adequate follow through. What will your ethos matter if you don’t actually DO something? It is no longer acceptable to say that this is not acceptable. We have no use for your anger. We need your action.
Epic, concrete, and systemic changes are needed and will be the only context under which real clinical trial diversity will transpire. Wherever the shoe fits, consider the cognitive dissonance you bring about when you allow these scenarios (and in no particular order):
- Do not treat Black and Brown communities as monolithic groups that have the same life experiences, backgrounds, income, education, language, customs, interests, attitudes, and opinions in common. We don’t.
- Do not pile people of color into presumptive stereotypes and shallow narratives, not the least of which is that Black people can only be reached through the church. Not true.
- Do not presume that distrust among Black people is tied only to Tuskegee, Henrietta Lacks, eugenics, and other infamous atrocities of the past. Today’s racism is more relevant to reluctance.
- Factor in relevant disease prevalence data—or acknowledge patterns of participation disparities in those areas—when designing protocols or planning recruitment initiatives.
- Beware feelings of privilege that allow the National Institutes of Health (NIH) mandate for inclusion to be ignored and enrollment to be closed without adequate minority representation; AND, check yourself when NIH allows continued federal funding despite noncompliance.
- Do more than “just enough” to comply with the U.S. Food and Drug Administration’s expectations of your New Drug Approval application, and spend more time investing in a real plan to prevent shortfalls than in crafting the explanation for them.
- Refuse to allow mere familiarity or convenience to be your site selection criteria, especially when those sites have no demonstrable reach in that community beyond their location.
- Never presume a team approach or a collaborative mentality and rely less on physician referrals to fill your study’s patient rosters.
- Provide physicians with easily accessible education about clinical trials allowing them to embrace medical research as a viable treatment option.
- Do not allow study goals and timeline to blind you to real people being the end-user; humanizing your workflow leaves room for humanizing the patient experience and establishing a foundation for trust.
- Put your studies through mock trials for a reality check through the lens of the patients you wish to enroll; when seeking to broaden DEI, check the protocol for inclusion/exclusion criteria that double as barriers to diversity, equity, and inclusion at your study’s gate.
- Put gatekeepers through sensitivity training developed by people of color.
- Bolster and guard your patient recruitment budget and make sure it is not allowed to become an afterthought.
- Make space, set aside resources, and allow time for an external task force to review and assess cultural sensitivity and patient centricity of study protocols so as to identify biases and barriers.
- Stop defaulting to doing business with majority-owned (read: White) marketing firms to resolve minority representation simply because they seem “safe” and familiar.
- Stop allowing fear of change to force a default to using status quo recruitment and retention activities simply because they seem “safe” and familiar.
- Establish quantifiable recruitment expectations for recruitment brokers based on demographics that reflect known data about the therapeutic area.
- Refuse to second-guess the pricing, professionalism, scalability, and ability to deliver the goods and services because it is a small, minority-owned business, especially when you would be less likely to treat a larger business of privilege with comparable scrutiny.
- Never solicit feedback from consultants (whether professionals, study participants, patients, or members of the community) and then fail to implement their recommendations; likewise, ensure credit and compensation where due.
- Stop cloaking your perception of expertise in whiteness first.
- Stop expecting study participants to take risks while you remain risk-averse in every possible way.
- Do not double down on disparities by setting conference fees that make attendance prohibitive for vendors of color (often classified as historically underutilized businesses [HUB] and/or certified minority- and women-owned businesses).
- Compensate keynote speakers to address diversity, equity, and inclusion, and make a sincere effort to book Black or Brown experts; also, don’t expect these experts to provide that expertise pro bono in this environment.
- Make certain your website’s homepage contains a “DIVERSITY, EQUITY, AND INCLUSION” section to demonstrate that you’re practicing what you preach about the DEI priorities of your organization.
- Allow transparent updates and real metrics around your dedication to diversity, equity, and inclusion, and be willing to be held publicly accountable.
Broken, But Not Beyond Repair
While the system has long been broken—and addressing it will require more than statements—I recognize the value in framing these issues in such a way that you will know that solutions are within reach and that there is a tantalizing variety (read: diverse array) of people, organizations, policies, and clinical interventions poised to change the landscape for the better.
In the meantime, know that It will take much more than throwing a fistful of money at a rescue attempt rather than planning better from the beginning.
Take a hard look at the participant invitation list created by your protocol design. The code for diversity, equity, and inclusion is written there in your inclusion/exclusion criteria.
If you are sincere about filling the studies of tomorrow with a broader spectrum of individuals, implementing the tools of transformation will require the guts to be honest with yourself about your commitment to see it through.
Don’t expect that attitudes about participating in research are distinct from how a person feels the system treats them or looks out for them. African American professionals and high-income earners—even those who work within industry—often express concerns about participating in research. Others of us who actively promote DEI in clinical trials deal with misgivings that linger.
Reconciling these issues is fundamentally a matter of perception. Getting to a better place in DEI efforts will demand significant outreach going forward—both broad and deep. Lamenting lack of diversity in studies while not going out of your way to do the work of making it better is business as usual. Engaging with underrepresented communities of color may require a departure from the status quo, but it’s not rocket science when you’re intentional.
Dedication to diversity, equity, and inclusion? It’s cliche without decisive action. To validate, consider this top 10 list:
- Humanize the process.
- Invest in relationships that serve all parties.
- Connect when a study is not hanging in the balance.
- Build infrastructure that will pay dividends.
- Invest in community-based relationships.
- Partner with skilled interpreters.
- Listen to patients.
- Keep your promises.
Reaching communities of color pivots on those in charge of clinical trials being more trustworthy. In other words, you first. Show us what you’re working with.
As for me, nobody is more interested to see how this goes.
Allison Kalloo, MPH, is founder and CEO of Clinical Ambassador Inc., founder of iParticipate Inc., Community Engagement Director and Innovation Strategist with EthosExcel, and a member of the Medable Patient Advisory Council.