Friday, January 15, 2016

Demonstrating the disease modifying effect through delayed start study design or delayed start analyses

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Previously, I described a study designed called ‘ randomized start design (RSD) ’. One special case of the RSD, delayed start design, has be...
Friday, January 01, 2016

Customizing the Kaplan-Meier Survival Plot in SAS

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Kaplan-Meier plot is very commonly used in analyzing the clinical trial data. If the study endpoint is time to event such as progression fre...
3 comments:
Thursday, December 17, 2015

Median of Differences versus Difference in Medians

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Both mean and median are used as location parameters to measure the central tendency of the data. If there is an intervention (such as drug...
1 comment:
Thursday, December 03, 2015

Dose Response Modeling: calculating EC50, ED50 by Fitting Emax Model using SAS Proc NLIN

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Dose response data can come from the laboratory test, pre-clinical, and clinical. The responses can be the assay results, fluorescence ou...
4 comments:
Saturday, November 21, 2015

Pediatric Study Plan (PSP) and Paediatric Investigation Plan (PIP)

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Pharmaceutical companies usually put their efforts into the adult population when they develop a new compound. There is usually  low rates o...
Monday, November 09, 2015

Human Genetic Enginering, DNA Modifications, DNA Editing, Genome Editing, Trans-humanism, Transgenic, xenotransplantation, Humanized Animals, and Human Chimeras

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Last week, NPR had a report "Should Human Stem Cells Be Used To Make Partly Human Chimeras?". Apparently, there was a meeting in N...

Minimizing the missing data: data collection after subjects withdraw from the clinical trial

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Recently, I have heard quite some discussions about the data collection in clinical trials for subjects who discontinue early from a clinic...