Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials

2019 ◽  
Vol 94 (1) ◽  
pp. 74-83 ◽  
Author(s):  
Daniel Shepshelovich ◽  
Ariadna Tibau ◽  
Hadar Goldvaser ◽  
Alberto Ocana ◽  
Bostjan Seruga ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Us

scholarly journals US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty?

2020 ◽  
Author(s):  
Roy Guharoy ◽  
Edward P Krenzelok
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Administration ◽  
Controlled Trial ◽  
Food And Drug Administration ◽  
Healthcare Providers ◽  
Efficacy And Safety ◽  
Open Label ◽  
Anecdotal Report ◽  
Randomized Controlled ◽  
The Us

Abstract Recently, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the treatment of hospitalized patients with coronavirus disease 2019 based on a non–peer-reviewed, open-label, observational study. Issuance of an EUA without a proven randomized, controlled trial (RCT) sets a dangerous precedent since the premature action drives healthcare providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recent debacle related to the rescinded EUA of hydroxychloroquine and chloroquine, which were approved initially based on an anecdotal report. The FDA process for determining efficacy and safety must be based solely on data from RCTs in order to sustain public and professional trust for future treatment and vaccine efforts to be successful.

Introduction: Randomization in the Tropics Revisited, a Theme and Eleven Variations

2020 ◽  
pp. 29-46
Author(s):  
Angus Deaton
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Years Of Experience ◽  
Welfare Policies ◽  
Randomized Controlled ◽  
The Us ◽  
The Tropics

Development economists have been using randomized controlled trials (RCTs) for the best part of two decades,1 and economists working on welfare policies in the US have been doing so for much longer. The years of experience have made the discussions richer and more nuanced, and both proponents and critics have learned from one another, at least to an extent. As is often the case, researchers seem reluctant to learn from earlier mistakes by others, and the lessons from the first wave of experiments, many of which were laid out by Jim Heckman and his collaborators...

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