PerspectiveBIOMEDICAL POLICY

Scientific considerations for global drug development

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Science Translational Medicine  29 Jul 2020:
Vol. 12, Issue 554, eaax2550
DOI: 10.1126/scitranslmed.aax2550

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Abstract

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

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