Ethical considerations in international clinical trial site selection

Area of Science:

• Global Health
• Clinical Research
• Health Equity

Background:

• New medicines and vaccines are primarily tested in high-income countries.
• Diseases like tuberculosis, HIV, and non-communicable diseases disproportionately affect low- and middle-income countries (LMICs).
• Clinical trial data may not be generalizable across regions due to potential variations in product effectiveness.

Purpose of the Study:

• To address the ethical arguments for a more equitable distribution of clinical trial sites.
• To improve access to the benefits of clinical research for LMIC populations.
• To ensure clinical evidence bases accurately reflect diverse global populations.

Main Methods:

• The study presents an ethical argument for revising clinical trial site distribution.
• It suggests increased transparency in trial site selection.
• It proposes that later-stage trial site selection should consider the global disease burden.

Main Results:

• Current disparities in clinical trial site distribution can impede equitable access to medical advancements.
• Variations in vaccine and drug efficacy have been observed across different geographical regions.
• LMICs bear a significant burden of diseases targeted by new medical interventions.

Conclusions:

• There are strong ethical imperatives to diversify clinical trial locations beyond high-income countries.
• Making trial site locations transparent is crucial.
• Future trial site selection, particularly for later-stage trials, must be informed by the global distribution of disease prevalence, incidence, and transmission rates to ensure equitable representation and access to novel medicines and vaccines.