On Biostatistics and Clinical Trials

The SF-36 is a multi-purpose, short-form health survey with 36 questions. SF-36 is one of the most popular instruments for generic health su...

I am very surprised to see how a simple concept of ‘incidence rate’ can be wrongly calculated in documents  submitted to regulatory agencies...

Pooling the study center for statistical analysis purpose is rather an old issue. However, we can still see the discussion o f study center ...

Nowadays, the clinical study protocols are becoming more and more complicated and require more and more blood sample draws for various purpo...

In clinical trial, one critical task is to ensure that the data collected or data entered into the system / database is valid, correct, and ...

When we move toward the clinical studies using electronic data capture, the ‘source data’ or ‘source document’ has been an issue. Unlike the...

Have you noticed the changes in the design of FDA website ( http://www.fda.gov/ ) recently? Last August, I mentioned the FDA's initiati...

In clinical trial and medical research, we often have a situation where two different measures/assessments are performed on the same sample,...

In statistics, bootstrapping is a resampling technique used to obtain estimates of summary statistics. In clinical trials, bootstrapping te...

For every clinical trial, we need to count the study day for calculating the follow-up visits and for assessing the temporal relationship...

There is a question and answer from 'AskMarilyn' at Parade.com . I copy the question and answer here since it is a probability issue...

RevMan (or Review Manager) is designed as a review tool to facilitate the literature review and the meta analyses by the Cochrane Collaborat...

In previous article, 'regulatory science' is discussed. 'Good Review Practice' can be considered one aspect of the regulator...

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and perform...

Missing data issues have been discussed and debated for many years. Handling of missing data in clinical trials has been recognized as an im...

In clinical trials, the efficacy endpoints are often measured as continuous variables. The hypothesis tests are used to determine whether or...

I came back from last week's FDA/Industry Statistics Workshop with more questions than answers. While the theme for this year's wor...

Often in clinical trial safety data analysis, people are confused with the basic concept of "number of events" vs "number of ...

Randomization is a fundamental aspect of randomized controlled trials (RCT) . When we judge a quality of a clinical trial, whether or not it...

There is a shift in drug development field from the chemical compounds to the biological products - protein products and a shift from tradit...