(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 in the Annals of Internal Medicine.
Researchers conducted a cross-sectional analysis of pivotal trials of new cancer, cardiovascular, and neurologic drugs approved from 2012 to 2019.
Data were included from 66 new drugs and 144 clinical trials, including a random sample of cancer drug approvals (28 of 85 drugs matched to 61 of 210 trials), all cardiovascular drug approvals (12 drugs, 29 trials), and all neurologic drug approvals (26 drugs, 54 trials).
The researchers found that 56% of cancer trials recruited from a LMIC, as did 79% of cardiovascular disease trials and 56% of neurology trials.
For 71 multi-country trials (55%), country-level enrollment figures were not available. For trials reporting enrollment per country, the percentage of participants recruited from LMICs was 8% for cancer trials, 36% for cardiovascular trials, and 17% for neurology trials.
“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 wrote. “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.”