On Biostatistics and Clinical Trials

In statistics or biostatistics, the multiple comparisons problem occurs when one considers a set, or family, of statistical inferences simul...

members of the FDA's oncology Drugs Advisory Committee cautioned sponsors against treating retrospective clinical trial biomarker analys...

Data dredging (data fishing, data snooping) is the inappropriate (sometimes deliberately so) search for 'statistically significant'...

EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, i...

The followings are copied from PARADE (Jan 11, 2009). I am not sure if these arguments (or suggestions) have any scientific merit, but I cop...

The recently-enacted FDA Amendments Act (“FDAAA”) has lots of requirements that may have impact on statistical analysis and programming. It...

People can be confused about the interpretation of the correlation coefficient, especially when we observe a small, but statistically signif...

Vision is typically reported as xxx/yyy where the xxx value is usually 20 for US assessments. As vision gets worse, for the same numerator, ...

From " http://www.delawareonline.com/article/20081230/BUSINESS/812300331 " AstraZeneca is considering joining several of its peers...

Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, fo...

I have been thought that the chinese traditional medicine from herbal is typically safe. However, recent discussions with my friends make me...

Sub-grouping damages the balance obtained by randomization If the randomization is stratified for one factor (for example, disease severity)...

The following annoucement really makes sense. Previously, FDA could issue an "approvable" letter that could be very confusing. A p...

In an article by Willke et al (Controlled Clinical Trials, 25, 2004), the study endpoints were classified as three major categories. Endpoin...

The newly released Declaration of Helsinki was issued by the 59th World Medical Association General Assembly in October 2008. This document ...

Words that end up in court Altered records, defect, falsification, hazardous, illegal, incompetence, inferior, negligent, reckless, wrongdoi...

One of my friends asked me what would be the source data and how to verify if the data was directly entered into EDC. A recent article in cl...

The recent effort to standardize the clinical data acquisition results in a lot of new acronyms . Some of them are listed below. A lot of th...

Training & Resources: Acrobat for life sciences blog - http://blogs.adobe.com/acrobatforlifesciences/ Acrobat legal links online - https...

The book by Drs Tozer and Rowland is pretty good. About dose "To paraphrase Paracelsus, who lived some 500 years ago, "all drugs a...