Monday, October 22, 2018

Potential Unblinding due to Imbalance in Adverse Event Profiles

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In a previous post “ Is blinded study really blinded? - assessment of blinding/unblinding in clinical trials ”, we discussed the potential...
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Sunday, October 07, 2018

Latin Squares for Constructing "Williams Designs" - Balanced for First-order Carry-over (Residual) Effects

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Courtesy from the website  http://statpages.info/latinsq.html , the list below contains the Williams design with 2 to 26 treatment groups. I...
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Monday, September 10, 2018

Randomized Withdrawal Design - Examples for Defining the Criteria for Run-in and Randomized Withdrawal Periods

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In a previous post, we discussed the " Randomized Withdrawal Design and Randomized Discontinuation Trial ". The randomized withdra...
Thursday, September 06, 2018

FDA Guidance: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

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Two years ago, I had a post discussing " Dose Cohort Expansion Study - A Never Ending Phase I Study Design ". Last month, FDA offi...
Saturday, August 11, 2018

Splitting p-value and estimate of the treatment difference

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When we perform the statistical test to compare the difference between two treatment groups, we usually construct a test statistic, calcula...
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Sunday, July 01, 2018

Geriatric Investigational Plan - Clinical Trials for Elderly

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Every clinical trial should have a protocol and the protocol needs to include the inclusion/exclusio criteria to define the study population...