On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Monday, April 17, 2023
Change from Baseline versus Percent Change from Baseline
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The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD)...
Tuesday, April 11, 2023
Obtaining standard deviations from standard errors and confidence intervals for group means
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Sometimes, we need to obtain a standard deviation (SD) in order to calculate the sample size for a new clinical trial where the primary effi...
1 comment:
Saturday, April 01, 2023
"Ensuring Public Trust in an Empowered FDA" - Accelerated Approval
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In the latest issue of New England Journal of Medicine , Drs Ross, Berg, and Ramachandran wrote a paper: " Ensuring Public Trust in an...
Saturday, March 11, 2023
Critical Dates after NDA/BLA submission: Filing Date (Day 1), Day 14, Day 60, Day 74, and PDUFA date
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After the NDA/BLA is submitted to FDA, the FDA review clock starts. There are several critical dates relevant to the applicant (the sponsor)...
3 comments:
Friday, March 03, 2023
Risk of Stopping Trial Early for Treatment Benefit - Story of Veru's Sabizabulin for Treatment of Covid
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Today, we learned that FDA declined to approve the emergency use authorization (EUA) for Veru's sabizabulin for the treatment of Covid. ...
2 comments:
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