What it means to be excluded from COVID-19 RCTs

We are all trying to offer our patients something to stave off the most terrifying outcomes of COVID-19 and to ease suffering. A lot of the clinical care everywhere right now is occurring in a data void. New IDSA guidelines on COVID-19, essentially a glorified literature review, give no treatment options or guidance to those of us without Randomized Control Trial (RCT) access in the United States. More RCTs are certainly needed to even remotely understand the risk-benefit balance of hydroxychloroquine/ azithromycin/ remdesivir/ tocilizumab/ sarilumab/ convalescent serum/ ivermectin/ etc etc etc. To this end, Gilead has decided that it will no longer provide compassionate use of remdesivir — with the exception of pregnant women and children who have severe COVID-19, a small fraction of the patients we serve. BMC has no open protocols. We are operating in a time where RCTs are critical to generating new understandings of this disease; RCTs are also one of the only channels into most treatment options at this time.

From both a scientific and an equity standpoint, Gilead and similar powerful pharma companies have a responsibility to open RCTs at hospitals that represent the communities hit hardest by this pandemic. Generalizability depends on reaching out to hospitals like BMC, which serves a population that is diverse in race, ethnicity, country of origin, and pre-existing medical conditions, like the co-morbidities we know are associated with worse outcomes.

From a health equity perspective, it would be shameful if pharma companies and the larger medical research community were responsible for further compounding the disparities that have already emerged in COVID-19. Communities like Chelsea, a majority Latino city north of Boston — where 80% of the population are service workers and are not given the privilege of social distancing — are suffering disproportionately from the spread of COVID-19. In Chicago, Boston, and other cities in the United States we have seen that people of color have had far higher mortality rates with the disease. And these communities are the same communities that make up much smaller proportions of the hospitals where RCTs are highly concentrated, at least in the Boston area.

The needs for expanded RCT access extend beyond the borders of the United States as elaborated in this Lancet article on a new global coalition to accelerate research in resource-limited settings. The Boston hospitals serve as a microcosm of much more extreme disparities in RCT access between high and low resource settings around the world. My hope is that efforts like the SOLIDARITY trial being set up by the WHO will serve as an example to other research efforts on how to bring together clinicians and researchers in a pragmatic way to lead to results that actually mean something to the communities that stand to suffer most from this disease. We are in a time where efficiency of results cannot come at the cost of exclusion.

Posted in BMC

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