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Tag Archives: statistical analysis
When Should You Write your Statistical Analysis Plans?
Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading
Posted in Clinical Trials, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
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Analysis of FDA Guidance on Adaptive Designs
In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s … Continue reading
