Saturday, June 22, 2019

Historical Control vs. External Control in Clinical Trials

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Last week, I had an opportunity to attend the annual ICSA Applied Statistics Symposium in Raleigh, North Carolina. The symposium had a lot ...
Monday, June 03, 2019

Six-Minute Walk Test (6MWT), 2-Minute Walk Test (2MWT), 12-Minute Walk Test (12MWT), and Timed Walk (T25FW, T10MW)

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Six-Minute Walk Test (6MWT) is to measure the distance in a fixed duration (6 minutes). It has been used as a clinical trial endpoint to me...
Monday, May 13, 2019

Pediatric Extrapolation for Pediatric Indication

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In a previous post " Pediatric Study Plan (PSP) and Paediatric Investigation Plan (PIP) ", we discussed the requirements for PSP a...
Thursday, May 02, 2019

FDA and EMA Guidance on Adjusting for Covariates in Randomized Clinical Trials

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Last week, FDA issues its draft guidance for industry titled ' Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biol...
Saturday, April 20, 2019

Hodges-Lehmann estimator of location shift: Median of Differences versus Difference in Medians or Median Difference

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Hodges-Lehmann estimator has been used to compare the treatment effect while the data is non-normal distributed. See my previous posts: Hod...
5 comments:
Monday, April 08, 2019

The Use of Restricted Mean Survival Time (RMST) Method When Proportional Hazards Assumption is in Doubt

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In a recent article from AJRCCM (American Journal of Respiratory and Critical Care Medicine), Harhay et al discussed " An Alternative A...
1 comment:
Monday, March 18, 2019

Adjudication Committee (AC), Endpoint Adjudication Committee (EAC), Clinical Endpoint Committee (CEC)

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The clinical trials are getting bigger and more complicated these days. For typical multi-national, multi-center pivotal clinical trials, th...