Sunday, May 13, 2018

Grading the Severity of AEs and its Impact on AE Reporting

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For all adverse events including serious adverse events in clinical trials, severity (or intensity) should be assessed and recorded. AE se...
2 comments:
Sunday, April 08, 2018

Clinical Trials Using Historical Control in Rare Disease Drug Development

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While the randomized, control clinical trial has become and remains to be the golden standard in drug development, we also see the increas...
Saturday, April 07, 2018

Generating graph / figure in publication quality

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As I was recently preparing a poster for ATS Internal Conference , I was told that the plots I provided were not in high quality. When placi...
1 comment:
Monday, March 05, 2018

Handling Randomization Errors in Clinical Trials with Stratified Randomization

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Stratified randomization is very common in randomized, controlled clinical trials. The usage of stratified randomization has been discuss...
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...