Monday, November 24, 2014

FDA's Position on Use of SI Units for Lab Tests

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Previously, I wrote an article to discuss the SI unit versus US conventional unit . FDA actually issued its position statement about these t...
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Sunday, November 16, 2014

VALOR Trial - A Successful and Failed Phase III Study with Adaptive Sample Size Re-stimation for Promising Zone

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Motivated by searching for the innovative clinical trial methodologies to increase the clinical trial success and minimize the clinical tri...
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Saturday, November 01, 2014

Standard of Care (SOC) as Control Group in Clinical Trials

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For randomized, controlled clinical trials, the selection of the control group is one of the key issues in the study design. This is why IC...
1 comment:
Saturday, October 18, 2014

The fixed margin method or the two confidence interval method for obtaining the non-inferiority margin

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For non-inferiority clinical trials, the key issue is to pre-specify the non-inferiority margin and the non-inferiority margin has to be ba...
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Saturday, September 13, 2014

N of 1 Clinical Trial Design and its Use in Rare Disease Studies

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In the beginning (February) of this year, I attended a workshop titled “Clinical Trial Design for Alpha-1 Deficiency: A Model for Rare Dise...
Saturday, September 06, 2014

Full Analysis Set and Intention-to-Treat Population in Non-randomized Clinical Trials?

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Intention to treatment principle has now been an routine term in the statistical analysis for randomized, controled clinical trials. If a p...
3 comments:
Friday, August 29, 2014

Subgroup Analysis in Clinical Trials - Revisited

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I had previously written an article about the sub-group analysis in clinical trials. I would like to revisit this topic. The subgroup anal...
Friday, August 15, 2014

SAE Reconciliation and Determining/recording the SAE Onset Date

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Traditionally clinical operations and drug safety / pharmacovigilence departments have elected to independently collect somewhat differen...
3 comments: