We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.
It is my hope that you will read this over and over again.
The fact that minorities (and African Americans in particular) are over-indexed in measures of poor health outcomes is nothing new. The coronavirus crisis has simply highlighted persistent disparities in both disease prevalence and the underrepresentation of minority populations in clinical trials. The fierce urgency to find real solutions to combat this deadly virus means that longstanding inequity may finally be getting the exposure it has needed. Hooray for 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.
Imagining the possibilities translates loosely into dreaming of dynamic public awareness campaigns, diversity-tailored programs, patient-centric campaigns, and more culturally sensitive protocols overall, and maybe even new interventions based on cutting-edge precision medicine initiatives that would allow medicine to take better care of its most vulnerable populations. Imagining the possibilities in the age of COVID also means being bombarded by news coverage from all corners discussing this need for diversity and the scientific community’s newfound dedication to achieving it. But if my hope and excitement are tinged with irony and incredulity, there’s a litany of historical reasons for that.
Industry stakeholders are appropriately acknowledging the need to be deliberate about recruiting participants of color. Attention here is long overdue. But sponsors are also more than familiar with the challenges they have faced with doing so. Failing to recognize pharmacogenetic and drug metabolism differences aside, being Black in America and being made to deal with systemic racism has proven to be its own risk factor. There is zero doubt that America’s unseemly past has managed to make African Americans fearful of stepping up to take advantage of participating in the very research that has the promise to save lives. Ironically, too few people know that the heinous Tuskegee Experiment had its own silver lining in being singularly responsible for the advent of informed consent.
COVID-19’s growing toll on all Americans, but the wide disparities by race reveals that the heaviest losses among Black and Indigenous Americans nationwide—more than twice as high as the rate for Whites and Asians. Attention is now on getting Black and Brown people to participate in clinical trials in numbers that reflect disproportional disease burden.
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.
While I am a staunch advocate for diversity in clinical trials and stepping up to participate (and I have, in more than a dozen studies over the years), there has been an elephant in my headspace taking up room when I sat down to coalesce my thoughts on the matter. Regardless of our tone of voice, body language, or facial expression and regardless of whether we might have been justifiably angry enough to “burn [edifices] down” there is a collective acknowledgement that we have to be able to estimate the blowback to speaking truth to power. These mental gymnastics have themselves caused trepidation and exist as a source of justifiable anger. 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 and collaboration 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 this 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 we 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. We call bullshit on any minority recruitment endeavors that coexist alongside any of the following. Wherever the shoe fits, consider the cognitive dissonance you bring about when you allow these scenarios (and in no particular order):
- Whenever you treat Black and Brown communities as monolithic groups who have the same life experiences, backgrounds, income, education, language, customs, interests, attitudes, and opinions in common. We don’t.
- Whenever you 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. Wrong.
- Each time your approach to minority inclusion is to treat unwillingness as cliche and to presume that distrust among Black people is tied only to Tuskegee, Henrietta Lacks and the infamous atrocities of the past. Today’s racism is more relevant to reluctance.
- Every time you fail to factor in relevant disease prevalence data— or to acknowledge patterns of participation disparities in those areas— when designing protocols or planning recruitment initiatives.
- Whenever privilege allows you to ignore the NIH mandate for inclusion and you complete enrollment without adequate minority representation; AND, whenever the NIH allows you to continue to receive federal funding in spite of your noncompliance.
- Every single time you do “just enough” to comply with the FDA for approval of your NDA, and when you have spent more time crafting the explanation for your shortfalls than you have investing in a real plan to prevent them.
- Each time you use mere familiarity or convenience as your site selection criteria when these sites possess no actual history with— or cultural connection to— the communities of color you seek to enroll.
- Whenever you presume a team approach or collaborative mentality and rely heavily on physician referrals to fill your study’s patient rosters.
- Whenever physicians are neither provided accessible education about clinical trials, challenged to embrace medical research as a viable treatment option, nor expected to broach the topic in consultations with their patients.
- Whenever your study goals and timeline so blind you to the humanity of your target patients that you fail to properly introduce yourself first, or invest in establishing a relationship and a foundation of trust.
- Whenever you implement the strictest (and least realistic) inclusion/exclusion criteria for participating in your clinical trials, creating de facto barriers to diverse, equitable and inclusive participation at the study gate.
- Each time you slash a patient recruitment budget, minimize its importance, fail to make patient recruitment a priority, or allow it to be an afterthought.
- Whenever you complain that diversity is “too expensive” or decide in advance that minority recruitment is too complicated.
- Whenever the IRB or any regulatory body alters the language that consultants have suggested related to anything patient-facing, including marketing, education or outreach— as if authority alone is synonymous with transparency or drives engagement.
- Whenever you don’t make space, set aside resources or allow time for an external task force to review and assess cultural sensitivity and patient-centricity of study protocols and to identify biases and barriers.
- Every time you default to doing business with majority-owned (read: White) marketing firms to resolve minority representation simply because they seem “safe” and familiar.
- Whenever fear of change forces you to default to using status quo recruitment and retention activities simply because they seem “safe” and familiar.
- Whenever you fail to establish quantifiable recruitment expectations for recruitment brokers based on demographics that reflect known data about the therapeutic area.
- Every time you second-guess the pricing, professionalism, scalability and ability to deliver the goods and services from a small minority-owned business when you would be less likely to treat a larger business of privilege with comparable scrutiny.
- Whenever you solicit feedback from consultants (whether professionals, study participants, patients, or members of the community) and fail to implement their recommendations— or fail to give them credit and compensation for their time.
- Whenever your perception of expertise is cloaked in whiteness first.
- Whenever you rely on study participants to take risks while you remain risk-averse in every possible way.
- Whenever you set high conference fees that are functionally exorbitant to attendees of color [often classified as historically underutilized businesses (HUB) and/or certified minority- and women-owned businesses], thereby making their attendance cost-prohibitive and effectively shutting out competent and competitive collaborators and doubling down on disparities.
- At the points where you compensate keynote speakers to address diversity, equity and inclusion, and that person is not Black or Brown; conversely, whenever you expect minority experts to provide that expertise pro bono.
- Whenever your website’s homepage lacks a “DIVERSITY, EQUITY & INCLUSION” section— or it is difficult to find readily— it belies corporate DEI policies and the stated priorities of your organization.
- When your public overtures regarding dedication to diversity, equity and inclusion (DEI) — whether at the corporate, HR or patient recruitment level — are not matched with adequate resources or a timeline of changes for which you’re also willing to be publicly accountable.
While the system has long been broken— and addressing it will require more than publicity statements and grandiose gestures— I recognize the value in framing these issues in such a way that you will know that solutions are within reach.
Let’s discuss this in an open manner that benefits the greater good. Let’s take a deeper dive and embrace the powerfully positive approaches we can cue up that will make the most difference.
In the blog series that will stem from this, I plan to explore dynamic recommendations from multiple sources (yes, more than just my own), and to showcase a tantalizing variety (read: diverse array) of people, organizations, policies and clinical interventions poised to change the landscape for the better over time. I hope you will stick with me for the ride.
But in the meantime, know that It will take much more than throwing a fistful of money at a rescue rather than planning better from the beginning.
Start by taking a hard look at the invitation list you inadvertently created with your protocol design. Who are you inviting to your party?
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.
One can’t expect to tease apart attitudes about participating in a clinical trial from how a person feels the system treats them. And this absolutely cuts across socioeconomic class. Even African American professionals and other high income earners openly express concerns about participating, and others of us harbor misgivings that still linger in the back of our minds.
Reconciling these issues is fundamentally a matter of perception. Getting to a better place in DEI work will demand significant outreach going forward— both broad and deep. Lamenting lack of diversity in studies while not doing the work to get out of your own way is disingenuous at best.
As an industry that uniformly proclaims how dedicated it is to diversity, you will want to pay attention to this pivot point in time. This is your opportunity to actually rise to this occasion to DO something. Make it profound.
Now is not the time to hold back.
Industry will need to address head-on the hesitancy of many who came by theirs honestly. But building trust is not rocket science. It's about building relationships and employing trusted messengers outside your direct influence.
Reaching out and across effectively is hinged 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