Thursday, March 24, 2016

Protocol Template for Clinical Trials

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For any clinical trial, the study protocol is the most critical document and is the blueprint of the entire study. There are clinical studi...
Monday, March 14, 2016

Targeted or Selective Safety Data Collection in Late Pre-authorisation and Post-authorisation Clinical Trials.

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Last month, FDA released its final guidance " Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late-St...
Tuesday, March 01, 2016

One-sided versus Two-sided test

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For vast majority of clinical trials, two-sided tests are performed and two-sided p-values are presented. Once a while, we will see some st...
2 comments:
Monday, February 15, 2016

Surrogate Biomarkers, Diagnostic Biomarkers, Prognostic Biomarkers, and Predictive Biomarkers

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A biomarker is a biologic molecule, such as a protein or gene, that is measureable in tissue, blood, or other body fluids, and is an indica...
1 comment:
Monday, February 01, 2016

Estimating the average treatment effects at two different visits and its implementation using MMRM model

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Orkambi is a combination drug including Ivacaftor and Lumacaftor and is approved by FDA for the treatment of cystic fibrosis in patients...
1 comment:
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...