Thursday, May 01, 2025

JSON vs SAS XPT Data Formats in Clinical Trial Data Submissions

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Regulatory study data (e.g. SDTM/SEND tabulations and ADaM analysis datasets) are currently exchanged in SAS XPORT (XPT) format, the legacy ...
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Monday, April 28, 2025

Vanda Pharmaceuticals Sues FDA Over Tradipitant Hearing Delay – A Misplaced Battle?

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This past week, Vanda Pharmaceuticals filed a federal lawsuit accusing the FDA of unlawfully delaying a hearing on the company’s new drug a...
Saturday, April 26, 2025

Comparison of “Serious Breach” (EMA) vs “Important Protocol Deviation” (FDA)

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International Council for Harmonisation (ICH) E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1) (20...
Friday, April 25, 2025

Classifying Protocol Deviations - New FDA Guidance on Protocol Deviations

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In clinical trials, protocol deviations are generally unintentional departures from the IRB-approved protocol and are commonly not discovere...
Saturday, February 15, 2025

Sponsor’s Response to DMC Recommendation: A Case Study from a Phase 2b/3 Trial

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 The DMC or DSMB is now commonly used in the clinical trials, especially the late phase clinical trials. According to FDA guidance for indus...
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Friday, February 14, 2025

Understanding Mis-Stratification in Randomized Controlled Clinical Trials

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Stratified randomization is a common practice in randomized, controlled clinical trials. It ensures that key characteristics are evenly dis...
Monday, January 13, 2025

Prognostic enrichment versus predictive enrichment

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Prognostic enrichment and predictive enrichment are both strategies used in clinical trials to select patients for inclusion. Both strategie...
Sunday, January 12, 2025

Survivorship Bias and its Occurrences in Clinical Trials

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Survivorship bias or survival bias is the logical error of concentrating on entities that passed a selection process while overlooking thos...