I’ve been thinking about the racial demographics of the phase 1 moderna #COVID19 mRNA vaccine study participants since yesterday. https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

A thread on #racism #healthequity #diversity in #clinicaltrials #blamenarratives and other stuff. 1/n
I’m an oncologist - so I think about clinical trials a lot. I’ve also been manipulating large health registry databases for my postdoc research.

Recently an interview panel member asked me about the racial/ethnic breakdown of one of the registries I use in my data analysis 2/n
A major issue (among many) with retrospective analyses of large registry studies is that these databases are not diverse.
The Nurse’s Health Study cohorts: As you might imagine, structural racism that kept Black people out of nursing also kept them out of inclusion in NHS 1&2. NHS3 is still enrolling & tapping the minority nurses association and using inclusion of students to boost diversity. 4/n
The Framingham cardiovascular study started enrolling participants in 1948. Surprise, also not diverse. Recognizing this, the research crew in 1994 established an “Omni cohort” specifically recruiting Black, Brown and Native people. 5/n
Medicare cohorts are about 75% White, 10% Black - but obv vary significantly based on registry location. It’s also common practice to exclude folks with HMO coverage or interrupted Medicare coverage from analyses which can further perturb racial breakdowns. 6/n
Then there are the foreign cohorts like the Swedish cohort and the UK biobank which are ... well ...from Sweden and the UK. Also not diverse. Let alone the wealth of other issues with applying observed health outcomes to populations in the US. 7/n
So these registries recruit mostly White participants but researchers use the long term health outcomes data to make generalizations with major health impacts for diverse populations. 8/n
This paper, which has been used in #cardiology to decide how to treat Black folk with heart failure is missing a very critical element required to make this claim: a White folk control. It’s a study of oranges that compares oranges to apples in its discussion. 10/n
Because I’m an oncologist and can’t help myself let’s chat quickly about #CARTcells. CAR-T cells are essentially scientists retrofitting your T cells to fight your cancer and represent one of the biggest breakthroughs in cancer care.
Chatting with folks who run clinical trials & registry studies will turn up various reasons for the lack of minority participation or recruitment. 15/n
The most commonly parroted is the “lack of trust” argument which leads invariably to citation of the Tuskegee Syphilis study 16/n
Of course, as @RheaBoydMD @mclemoremr, @EdwinLindo and I wrote in our recent health affairs piece, “Any mistrust Black patients may harbor toward the US health care system is a result of their never ending mistreatment, not the cause of it.” https://www.healthaffairs.org/do/10.1377/hblog20200630.939347/full/?utm_medium=social&utm_source=twitter&utm_campaign=blog&utm_content=Boyd 17/n
The other folly of blame narratives is that they ignore the enormous burden placed on patients by the practicalities of clinical trial participation. Visits are more frequent, there are often extra blood draws and biopsies which have to be done at the sponsoring center. 18/n
For a phase 1 study, where safety and pharmacokinetic information is desired, you’re often in the infusion center hours after your dose completes awaiting subsequent lab draws so the team can collect PK samples/data. 19/n
There is no compensation aside from altruism and a possibility (with uncertain odds) of efficacy. Without the benefit of medical leave from work, child care support at home, independent financial means, ability to travel to extra visits... 20/n
... it is difficult to agree to participate in these trials. Asking a primary breadwinner to risk his job by clinical trial participation is different from asking someone who is buttressed by family financial support. Altruism cannot be traded for goods and services. 21/n
This quote echoes this sentiment:
Article here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5599206/#__ffn_sectitle
So that was a long windy road, but wanted to give you the ground from which I’ve been wrestling with the idea of Black folk participation in #COVID19 clinical trials offered by Moderna and others. 25/n
so it’s clear: I believe in clinical trials. I believe Black people (and other underrepresented populations) should enroll in clinical trials. I believe trial investigators have an obligation to recruit participants that reflect their target population 26/n
It is, however, not at all surprising to me that Black folks were not enrolled in the Moderna study at a number that reflects a representative proportion of the population or the relative need for a #Covid19 vaccine.

Part of the issue is how information about trials for coronavirus have been reported. For example, the AstraZeneca study that began in London didn’t pick up in popular press until the South African & Brazilian arms opened. 28/n
What doesn’t help matters is how money is changing hands regarding the most promising vaccines. The US brought up doses of a vaccine that is still unproven...30/n
Then there’s the problematic philanthropy of Bill and Melinda gates. That’s all I’ll say about that - could do a stand alone thread on these two. 32/n
So you have a clinical trial - which *is* an experimental medical intervention. Scientists have equipoise from preclinical data but at the end of the day, trials are an experiment. Efficacy may not pan out in phase 3. Safety issues could come to light when it’s scaled up. 33/n
People of any race deciding that they “don’t want to be experimented on” absolutely have that right. 34/n
It is ethically problematic to coerce clinical trial participation - whether through offering financial incentive by guilting a demographic into participating or by under emphasizing the experimental nature of these studies. 35/n
Then you have sensationalized reporting and capitalist corruption on a backdrop of anti-Black racism and medical apartheid. Why exactly would Black people without any reassurances of efficacy, guaranteed protection against exploitation, or social security flock to any study? 36/n
As we contemplate anti-racism and health equity in American medicine & research, I hope we can have the real come to Jesus moment that is required to *really* change the status quo in clinical research: 37/n
1- we need uniformity in reporting on racial demographics in clinical trials and registry studies. Trials that do not represent the population demographically should say it up front.

2- all patients should be informed of clinical trials available - providers should never just assume they won’t want to or too are because of perceived race

3- ideally, medical and research communities would divest from politics and capitalism. This means single payer health care. This means need-based supply of scarce resources and experimental novel therapies. This means media reports the facts not catchy headlines 40/n
4- while coercion is wrong, we need to acknowledge that burden of trial participation is not equal (and that this is by design in a society built on structural racism/inequities)
You don’t want to pay people to enroll in studies, but what assurances can you provide to participants for child care, lobbying employers to provide adequate leave, flexible scheduling, medical insurance and to not fire them? What transportation is available? 42/n
5- we must reckon with our past & present sins beyond citingTuskegee to blame Black people for not caring for themselves properly. Part of informed consent is knowing where your experimental therapy lies relative to standard of care. 43/n
But also because of past and present racism, lack of exploitation in clinical research is *NOT* a given. So, when we recruit into trials we should be transparent about safety nets that are in place to prevent exploitation. 44/n
If we cannot or will not do these things the calls for #diversityandinclusion in clinical trials are just as hollow as the calls for D&I in academic medicine have been for decades. 45/n
I absolutely want Black people to get COVID19 vaccines. But I don't want exploitation or lack of empathy for Black folk who are already managing so much of #America2020. I 100% get the choice to feel this one out before jumping right in as a clinical trial participant. 46/n
We have work to do - and it starts with changing how we structure clinical research and clinical trial enrollment practices 47/fin
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