Challenges in confirming drug effectiveness after early approval
Science
.
2021 Dec 3;374(6572):1205-1207.
doi: 10.1126/science.abk3495.
Epub 2021 Dec 2.
Authors
Holly Fernandez Lynch
1
,
Christopher T Robertson
2
Affiliations
1
University of Pennsylvania, Philadelphia, PA, USA.
2
Boston University, Boston, MA, USA.
PMID:
34855490
DOI:
10.1126/science.abk3495
Abstract
Reform requires clarity about whether, when, and how meaningful postapproval trials are possible.