Tuesday, January 23, 2018

CDISC (CDASH and STDM) and Protocol Deviations

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I have previously discussed the protocol deviation issues in clinical trials. Inclusion/exclusion violations, protocol deviations, prot...
3 comments:
Thursday, January 11, 2018

Statistician's nightmare - mistakes in statistical analyses of clinical trials

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Statistician’s job could be risky too. In recent news announcement, sponsor had to disclose the errors in statistical analyses. All the...
Tuesday, January 02, 2018

Adverse Event Collection: When to Start and When to Stop?

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In clinical trials, the most critical safety information is the adverse event (AE). There are numerous guidance and guidelines regarding th...
1 comment:
Saturday, December 23, 2017

Composite Endpoint and Competing Risk Model

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A competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. For example, when the primary outc...
1 comment:
Sunday, December 10, 2017

Recurrent Events versus Composite Events: Statistical Analysis Methods for Recurrent Events

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Recurrent events are repeated occurrences of the same type of event. Composite endpoint is a combination of various clinical events tha...
Tuesday, November 28, 2017

Bonferroni method, alpha level partition, and gatekeeper hierarchical test strategy in Bronchiectasis clinical trials

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In  a recent FDA advisory committee meeting  in November 16, 2017, we learned the first hand application of the various approaches for mult...