Thursday, February 22, 2018

New FDA Guidance Documents for Drug Development in Neurological Conditions Aiming to Ease the Drug Approval Paths

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This month, we saw FDA issued five guidance documents for drug development in five different neurological conditions/diseases (Alzheimer’s...
Monday, February 12, 2018

Weighted Bonferroni Method (or partition of alpha) in Clinical Trials with Multiple Endpoints

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In a previous post , the terms of ‘multiple endpoints’ and ‘co-primary endpoints’ were discussed. If a study contains two co-primary effic...
Thursday, February 01, 2018

Handling site level protocol deviations

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In previous post , the CDISC data structure for protocol deviations was discussed. The protocol deviation data set (DV domain) is an event d...
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...