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...
1 comment:
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...
Saturday, June 16, 2018

Sample Size Calculation Without Considering Dropout Rate

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When planning for clinical trials, sample size calculation is a two-step or three-step process. For clinical trials with continuous variable...
1 comment:
Saturday, June 09, 2018

Expectedness Assessment: Expected / Unexpected Adverse Events and SUSAR

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In clinical trials, reporting of adverse events is critical to ensure the safety of participants. When an adverse event is reported, it is ...
1 comment:
Sunday, May 13, 2018

Grading the Severity of AEs and its Impact on AE Reporting

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For all adverse events including serious adverse events in clinical trials, severity (or intensity) should be assessed and recorded. AE se...
2 comments:
Sunday, April 08, 2018

Clinical Trials Using Historical Control in Rare Disease Drug Development

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While the randomized, control clinical trial has become and remains to be the golden standard in drug development, we also see the increas...