Scientific considerations for global drug development.

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.

SUBMITTER: Wilson JL 

PROVIDER: S-EPMC8158457 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature