RT Journal Article
SR Electronic
T1 Scientific considerations for global drug development
JF Science Translational Medicine
FD American Association for the Advancement of Science
SP eaax2550
DO 10.1126/scitranslmed.aax2550
VO 12
IS 554
A1 Wilson, Jennifer L.
A1 Cheung, Kit Wun Kathy
A1 Lin, Lawrence
A1 Green, Elizabeth A. E.
A1 Porrás, Analia I.
A1 Zou, Ling
A1 Mukanga, David
A1 Akpa, Paul A.
A1 Darko, Delese Mimi
A1 Yuan, Rae
A1 Ding, Sheng
A1 Johnson, Wiltshire C. N.
A1 Lee, Howard A.
A1 Cooke, Emer
A1 Peck, Carl C.
A1 Kern, Steven E.
A1 Hartman, Dan
A1 Hayashi, Yoshikazu
A1 Marks, Peter W.
A1 Altman, Russ B.
A1 Lumpkin, Murray M.
A1 Giacomini, Kathleen M.
A1 Blaschke, Terrence F.
YR 2020
UL http://stm.sciencemag.org/content/12/554/eaax2550.abstract
AB 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.