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...
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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...
Monday, January 07, 2019

Placebo Effect, Honest Placebo, Open-label Placebo

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In a previous post, I discussed the Placebo Effect and The Choice of Placebo . When a placebo-control trial failed, we would try to underst...
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Monday, December 10, 2018

Visit Window for Longitudinal Studies

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In the previous post, the time window was discussed. The time window is an issue in studies with relatively shorter durations (such as the ...
Monday, December 03, 2018

Time Windows for PK Blood Sampling

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In the drug development process, especially the early non-clinical or clinical studies, it is critical to understand the DMPK. DMPK, or Dru...
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Wednesday, November 07, 2018

FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making

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FDA In Brief: FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making FDA’s My...
Thursday, November 01, 2018

Fitting Compartment Models Using PROC NLMIXED

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There is a new article on SAS's website " Fitting Compartment Models Using PROC NLMIXED ". It is nice to know that SAS Proc NL...
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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