On Biostatistics and Clinical Trials

Sometimes, it is necessary for us to calculate the p-values based on the summary (aggregate) data without the individual subject level data....

It is pretty common these days that clinical trials (especially the late phase, adequate, and well-controlled studies) employ interim analys...

In late-phase clinical trials, an independent Data Monitoring Committee (DMC) is usually set up. If the clinical program includes multiple l...

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

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

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

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

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

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