Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs

Key Points Question How commonly are drugs commercially available in the countries where they were tested? Findings This cross-sectional study found that 5 years after their approval in the US, 15% of novel drugs (5 of 34 drugs) were approved in all countries where they were tested; among 70 countries contributing research participants, 7% (5 countries) received market access to the drugs they helped test within 1 year of US approval and 31% (22 countries) did so within 5 years. Approvals were faster in high-income countries, and access was lowest in African countries. Meaning These findings suggest that substantial gaps exist between where drugs are tested and where they become available to patients, raising concerns about the equitable distribution of research benefits.