Saturday, June 16, 2018

Sample Size Calculation Without Considering Dropout Rate

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When planning for clinical trials, sample size calculation is a two-step or three-step process. For clinical trials with continuous variable...
1 comment:
Saturday, June 09, 2018

Expectedness Assessment: Expected / Unexpected Adverse Events and SUSAR

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In clinical trials, reporting of adverse events is critical to ensure the safety of participants. When an adverse event is reported, it is ...
1 comment:
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...