On Biostatistics and Clinical Trials

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...

I recently noticed that for the approval of the new drugs (NDA) and biological products (BLA), the information about the approval process wa...

In clinical trials, subjects are usually followed up for a period of time with multiple measurements / assessments at various time points. I...

Sometimes, simple linear regression may not be very simple. One of the issues is to decide whether or not to fit the regression with the int...

In regulatory setting, can we show the treatment difference by comparing the slopes between two treatment groups? In a COPD study (e.g., a...

The health reform legislation that was recently signed into law contains a provision that creates a pathway to enable the US Food and Drug ...

I noted that FDA recently issued its draft guidance on non-inferiority clinical trial design . Two weeks ago, I attended the DIA webinar ...

According to Wikipedia, "the Hodges–Lehmann estimator is a method of robust estimation . The principal form of this estimator is used ...

In April, 2010, " the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (104715) (PSCPAC) " discussed the issues...