When countries hosts clinical trials for new medicines and vaccines, most of us assume patients there will eventually benefit from the products they helped test. According to the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) guidelines, populations who bear the burdens of research should share in its benefits.
Our new study suggests this assumption is often wrong.
Looking at all 172 novel medicines approved by the FDA from 2015–2018, we asked a basic operational question with big ethical implications: Are these medicines physically accessible, i.e., granted marketing authorization, in the countries where they were tested, and has access improved over time?
The answer: For most trial-hosting countries, especially low- and middle-income countries (LMICs), the medicines never arrive or arrive years late.
Read the study in JAMA IM here. See our founder’s commentary on the study, here.