1.
Sci Transl Med
; 12(554)2020 07 29.
Artigo
em Inglês
| MEDLINE
| ID: mdl-32727913
RESUMO
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.