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Recruitment of Pivotal Clinical Trial Participants From Low- and Middle-Income Countries

A study shows that participants in many pivotal drug trials are recruited from low- and middle-income countries (LMICs), but country-level demographics are not usually reported in FDA documents. “Although recruitment is often reported by region or continent, such groupings can obscure important differences among host countries,” conclude the authors. “The sporadic availability of per country enrollment can frustrate the valid interpretation of pivotal trial findings. It can also limit the ability to monitor and hold research sponsors accountable for fair participant selection. We urge journals, regulators, and ClinicalTrials.gov to establish policies that require public reporting of country-level information on recruitment.”

Data from ClinicalTrials.gov, FDA records, and publications were compiled for pivotal trials of new cancer, cardiovascular, and neurologic drugs approved from 2012 to 2019. Based on a primary endpoint of the proportion of clinical trials that enrolled participants from LMICs, the investigators found these results: “Data were obtained from 66 new drugs and 144 pivotal clinical trials. All cardiovascular approvals (12 drugs, 29 trials) and neurologic approvals (26 drugs, 54 trials) were analyzed, as well as a random sample of cancer approvals (28 of 85 drugs [33%]) matched to their pivotal trials (61 of 210 trials [29%]). Among the trials, 56% in cancer, 79% in cardiovascular disease, and 56% in neurology recruited from an LMIC. For multicountry trials, country-level enrollment figures were not available for 71 trials (55%). For those reporting per country enrollment, the percentage of participants recruited from LMICs was 8% for cancer trials, 36% for cardiovascular trials, and 17% for neurology trials.”

Source: Annals of Internal Medicine