Most Pivotal Trials of New Drugs Recruit From Low-, Middle-Income Countries

MONDAY, Nov. 21, 2022 (HealthDay News) -- Most pivotal trials of new cancer, cardiovascular, and neurologic drugs recruit from low- and middle-income countries (LMIC), according to a study published online Nov. 22 in the Annals of Internal Medicine.

Fareed A. Awan, Ph.D., from McGill University in Montreal, and colleagues conducted a cross-sectional analysis of pivotal trials of new cancer, cardiovascular, and neurologic drugs approved from 2012 to 2019. Data were extracted on host countries and available per country enrollments to describe LMIC recruitment.

Data were included from 66 new drugs and 144 clinical trials, including all cardiovascular approvals (12 drugs, 29 trials), all neurologic approvals (26 drugs, 54 trials), and a random sample of cancer approvals (28 of 85 drugs matched to their 61 of 210 trials). The researchers found that 56, 79, and 56 percent of trials in cancer, cardiovascular disease, and neurology, respectively, recruited from an LMIC. For 71 multicountry trials (55 percent), country-level enrollment figures were not available. For those reporting enrollment per country, the percentage of participants recruited from LMICs was 8, 36, and 17 percent for cancer, cardiovascular, and neurology trials, respectively.

"Most pivotal trials for cancer, cardiovascular disease, and neurology draw participants from LMICs, and in cardiovascular indications, a substantial proportion of patients derive from LMICs," the authors write. "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."

Abstract/Full Text (subscription or payment may be required)