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...
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...
Sunday, December 29, 2024

Bioethics with Biotechnology, Bioengineering, and Genetic Engineering

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Biotechnology and bioengineering are advancing at an unprecedented pace. Through genetic engineering, possibilities once considered unthinka...
Saturday, December 28, 2024

Known knowns and Unknown Unknowns

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On several occasions during scientific presentations, I have come across citations of Donald Rumsfeld's statement. Donald Rumsfeld was o...
Friday, November 29, 2024

Real world data (RWD) and Real world evidence (RWE) in Drug Development

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The 21st Century Cures Act (Cures Act) , signed into law on December 13, 2016, is designed to accelerate medical product development and bri...