Considering whether countries participating in clinical trials can afford the intervention.

Abstract

... Clinical trials often recruit from a diverse array of countries to help researchers understand the generalizability of their intervention. The economic circumstances in participating countries may vary substantially. This raises the issue of whether the intervention, even if proven to be effective and cost-effective in wealthy countries, would be cost-effective among resource-limited participant countries. It is only fair that states who help establish an intervention benefit from that intervention immediately after the trial concludes and over an extended period. However, this may be difficult to achieve, particularly for interventions that are inexpensive and exhibit small absolute health gains (cost-effectiveness ratios are generally easier to improve upon for expensive and/or highly effective interventions). Here, we provide an example. It is well established that HIV infection, even when well treated, increases the risk of atherosclerotic cardiovascular disease (ASCVD; Shah et al., 2018). In 2015, a large clinical trial, the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), was launched to test the effectiveness of statins for primary prevention of ASCVD in people living with HIV (PLHIV) at low to moderate risk of cardiovascular disease based on an assessment of traditional risk factors (ClinicalTrials.gov, 2020). Generic statins cost <$1 per day in most parts of the world and typically reduce ASCVD incidence by between 10% and 30% (Cholesterol Treatment Trialists’ Collaborators, 2012). Estimates of primary ASCVD incidence in the current HIV population range from 3 to 6 per 1000 person-years (Friis-Moller et al., 2016; Boettiger et al., 2020). REPRIEVE has now recruited 7770 participants from 11 countries, 9 of which are classified as low- or middle-income (The World Bank, 2020). The results are expected in 2023.