On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
RWE/RWD
.
Show all posts
Showing posts with label
RWE/RWD
.
Show all posts
Friday, November 29, 2024
Real world data (RWD) and Real world evidence (RWE) in Drug Development
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The 21st Century Cures Act (Cures Act) , signed into law on December 13, 2016, is designed to accelerate medical product development and bri...
Sunday, May 22, 2022
The Use of External Controls in FDA Regulatory Decision Making and Bayesian Borrowing
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An good article by Jahanshahi et al "The Use of External Controls in FDA Regulatory Decision Making". The authors reviewed and su...
Monday, January 04, 2021
Synthetic Control Arm (SCA), External Control, Historical Control
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Lately, the term 'synthetic control' or 'synthetic control arm' or SCA, in short, is becoming popular - it is mainly driven ...
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Monday, October 26, 2020
Real World Evidence in Regulatory Submissions - Story of IBRANCE for male breast cancer
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In April 2019, FDA approved Pfizer's IBRANCE for male breast cancer . The approval is for the label extension for an already produce bas...
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