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:
Tuesday, July 15, 2014

Pre-screening procedures in clinical trials

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For typical clinical trials, the study design will include a screening period before the randomization / start of the study medication. The ...
5 comments:
Saturday, July 12, 2014

Clinical Trial Registries in US, EU, WHO, China, and other countries

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For the past decade, there was increasing pressure on pharmaceutical companies to be transparent on the clinical trials and the clinical tri...
1 comment:
Saturday, June 21, 2014

Is MMRM Good Enough in Handling the Missing Data in Longitudinal Clinical Trials?

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In last 7-8 years, there is a gradual shift from using the single-imputation method such as LOCF to MMRM (mixed model for repeated measurem...
Tuesday, June 10, 2014

Mixed effect Model Repeat Measurement (MMRM) and Random Coefficient Model Using SAS

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The clinical trial data presented to us are often in longitudinal format with repeated measurements. For Continuous Endpoints in Longitudin...
3 comments: