African-American enrollment disproportionately high in no-consent trials
pharmafile | October 2, 2018 | News story | Manufacturing and Production, Research and Development | FDA, clinical trials, pharma, transparency
A new study has revealed that African-American citizens make up a disproportionately high share of participants in US clinical trials conducted through the ‘Exception from Informed Consent’ (EFIC) pathway – studies which do not require consent from the patient, usually because they are unable to respond, before testing emergency medical procedures on them.
An example of such a situation may be administering an unconscious patient with an alternative drug combination to treat a health condition with obtaining their consent, so long as specified conditions are met beforehand.
The study, entitled A Systematic Review of the Food and Drug Administration’s ‘Exception from Informed Consent’ Pathway, found that African-American and black patients accounted for 29% of all such trial participants – more than double the proportion they make up of the total US population at 13%, according to the US Census Bureau.
This figure is also proportionally much higher than the 14% they occupy of all clinical trials, according to the FDA. This participation rate itself is low, with a ProPublica report arguing that the group is underrepresented in clinical trials.
The study examined all 41 FDA studies conducted through the EFIC pathway over the past 20 years, encompassing 46,964 patients, of whom 96% were enrolled without consent. The interventions used in just two trials demonstrated clinical benefit, while many administered in the rest of the studies led to increased mortality, neurological deficits and myocardial infarctions.
While the reason for this overrepresentation cannot be accurately determined, it is thought possible that these trials are conducted at large academic medical centres where a large proportion of African-American patients are located who are affected by the studied conditions.
Matt Fellows
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