On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Sunday, July 20, 2025
ICH E21 "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials"
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US FDA has just endorsed the draft guideline of ICH E21 " Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials "...
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Friday, July 04, 2025
Rank Analysis of Covariance (RANK ANCOVA) versus Aligned Rank Stratified Wilcoxon Test
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In clinical trials where outcome measures violate the assumptions required for parametric statistical methods such as analysis of covariance...
Tuesday, July 01, 2025
ICH E20 "Adaptive Designs For Clinical Trials" and FDA Guidance "Adaptive Designs for Clinical Trials of Drugs and Biologics"
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The International Council for Harmonisation (ICH) has released its highly anticipated draft guideline that harmonizes principles for the de...
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