December 20, 2021

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies

The COVID-19 pandemic exposed that some hospitals lack clinical trial opportunities for patients during public health emergencies. In a new paper in  Hastings Center Report, Holly Fernandez Lynch and co-authors explore how hospitals can ethically and equitably allocate these opportunities to patients beyond singular use of the most common methods: patient choice, physician referral, and randomization/lottery.

From Hastings Center Report:

An overarching equity issue when considering enrollment opportunities for Covid-19 trials is related to the effects of profound health disparities on U.S. communities of color. Disparities in Covid-19 infection rates and outcomes by race and ethnicity are promulgated by individual, institutional, and structural racism, which influences exposure to the virus, susceptibility to contracting the virus, ability to quarantine from and within households, access to treatment, and underlying comorbidities.12 The impact of these inequities is stark. Numerous reports have demonstrated that Native Americans, Latinos, and Black and African American patients are being hospitalized and dying at higher rates than White patients are in several states. These rates are not a reflection of biological differences between people of different races and ethnicities but, rather, reflect the differential risk for “racism-related exposures.”

Despite being overrepresented among patients hospitalized with Covid-19, Black, Latino, and Native American populations have been disproportionately underrepresented in Covid-19 trials. When designing equitable allocation structures for trial enrollment opportunities, hospital and public health leadership at the state and federal levels needs to acknowledge the history of racism that first established these social indicators of health and ensure that all populations have equitable access to the potential benefits of research. In addition, racism can cause race-based differences in the treatment of participants in outpatient and pragmatic trials. Because hospital and public health leadership must anticipate that racism will continue to exist when any successful trial products are implemented, not only equitable access to benefits but also the generalizability of trial results require diverse trial enrollment. For opportunity to translate into participation, the provision of equitable opportunities for trial participation will likely need to be combined with efforts to promote trust in the research enterprise at the community level.

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