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

Abstract

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.

Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials

“…1 Low- and middle-income countries have experienced significant delays in vaccine access despite initiatives aiming to ensure fair distribution, such as COVID-19 Vaccines Global Access (COVAX). 2 Because pharmaceuticals do not receive consistent and timely authorization for use in lower-income countries where they are tested, 3 we examined authorization and delivery of COVID-19 vaccines recommended by the World Health Organization (WHO) in the countries where they were tested.…”

Ethical considerations in international clinical trial site selection

“…Governments, research sponsors and investigators have obligations to—collectively—promote the health of all. Yet, compared with the patients who actually have the conditions being studied, new medicines and vaccines are often disproportionately tested on populations who are healthier, younger, more likely to identify as white,26 27 and live in urban areas28 and high-income or upper-middle-income countries 1. When the evidence base for new interventions is dominated by data from unrepresentative populations, it may not generalise to patient populations with different disease severities, comorbidities, dietary and nutritional profiles, access to supportive care, age groups and geographies.…”

“…New medicines and vaccines are predominantly tested in wealthier countries. A study of US Food and Drug Administration (FDA) approved novel therapeutics in 2012 and 2014 revealed they were tested in a median of 20 high-income and 6 upper-middle countries, but only 1 lower-middle and no low-income countries 1. Similarly, the COVID-19 vaccines recommended by WHO for emergency use authorisation, and authorised for use in several low-income and middle-income countries (LMICs), were disproportionately tested in high-income and upper-middle-income countries 2…”

“…Countries with high prevalence, incidence, severity or infection transmission rates for targeted diseases should have real opportunities for their populations to enrol in trials for novel new medicines and vaccines 14. As a first step, we suggest trial locations should be more transparent, as studies have shown only about 37% of trials supporting FDA novel drug approvals have publicly available trial site locations in the medical literature or a registry like ClinicalTrials.gov 1…”

Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials

“…1 However, low-and middle-income countries have experienced significant delays in vaccine access despite mechanisms meant to ensure fair distribution, such as COVAX. 2 Because prior research has shown that pharmaceuticals do not receive consistent and timely authorization for use in lower income countries where they are tested, 3 we examined the authorization or approval and delivery for COVID-19 vaccines recommended by the World Health Organization (WHO) in the countries where they were tested.…”