Science Translational Medicine
29 July 2020 Vol 12, Issue 554
Scientific considerations for global drug development
By Jennifer L. Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A. E. Green, Analia I. Porrás, Ling Zou, David Mukanga, Paul A. Akpa, Delese Mimi Darko, Rae Yuan, Sheng Ding, Wiltshire C. N. Johnson, Howard A. Lee, Emer Cooke, Carl C. Peck, Steven E. Kern, Dan Hartman, Yoshikazu Hayashi, Peter W. Marks, Russ B. Altman, Murray M. Lumpkin, Kathleen M. Giacomini, Terrence F. Blaschke
Science Translational Medicine29 Jul 2020 Restricted Access
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.