Monday, December 27, 2021

Futility Analysis and Conditional Power

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Adaptive design has been used to drug development programs more efficient. According to FDA's guidance  Adaptive Designs for Clinical Tr...
Saturday, December 11, 2021

Interventional Study (Clinical Trial), Non-interventional Study (Observational Study), and Registry Study

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 FDA recently issued two separate guidance documents for industry:  Considerations for the use of real-world data and real-world evidence to...
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Wednesday, December 01, 2021

Clinical Trial Design: Double-Blind Fixed Duration Trial with Long-term Double-Blind Various Treatment Duration

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The randomized, double-blind, parallel-group design is the most common type of design for clinical trials (especially the confirmatory clini...
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Friday, November 26, 2021

Venn Diagram to Display the Distribution of the Adverse Events

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Visualizing the clinical trial data is becoming more common and various plots can be drawn to visualize the data. In previous posts, we disc...
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Wednesday, November 24, 2021

Are data listings for clinical study reports still needed in the era of CDISC standard data sets (SDTM)?

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Traditionally, all data fields that are collected in clinical trials, will be listed in so-called 'data listings'. The data listings...
Sunday, October 17, 2021

Protocol Deviations - How is the Protocol Deviation Data Analyzed and Used?

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For any clinical trial, the study protocol is the blueprint of how the clinical trial should be conducted. C linical study protocols must be...
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Sunday, October 10, 2021

Recommendations for DMC: How Many Statisticians Need to be Involved in Successful DMC Process?

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Independent data monitoring committee (iDMC) is more commonly used in clinical trials than before for various reasons. For innovative and co...
Friday, October 08, 2021

Serial Blood Sample Timepoints for Comparing Pharmacokinetics Profiles Between Two Different Dose Frequencies

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It is very common in the drug development process that the dosing frequency needs to be studied. The dosing frequency is usually based on th...
Monday, September 27, 2021

Advancing the Development of Pediatric Therapeutics (ADEPT) - FDA Workshops on Pediatric Drug Developments

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Each year, the FDA's Division of Pediatrics and Maternal Health in collaboration with the University of Maryland CERSI organized an an...
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