Scientific considerations for global drug development

Sci Transl Med. 2020 Jul 29;12(554):eaax2550. doi: 10.1126/scitranslmed.aax2550.


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Developing Countries*
  • Drug Approval
  • Drug Costs*
  • Drug Development