On Biostatistics and Clinical Trials

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I noted that FDA recently issued its draft guidance on non-inferiority clinical trial design .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...

CDISC stands for the Clinical Data Interchange Standards Consortium. I have always been thinking that the CDISC is about the data standard ...

In China, drug and biological products are regulated by SFDA ( 国家食品药品监督管理局 ). sFDA is a counterpart of US FDA. Its Center for Drug Evaluati...

Recently, a group of statisticians in Linkedin.com (presumabally all working in drug development industry) discussed the following posted q...

Hockey stick phenomenon or hockey stick curves has been used mostly in describing the climate change. it says that the tempeature variation...

The term 'globalization' is nothing new. According to Wikipedia , "globalization describes an ongoing process by which regional...

According to dictionary.com, the term "dealer's choice" is defined as " a card game, as poker, in which the dealer decid...

"Ghost writing" practice has been criticized recently due to the reveal of details targeting several big pharmaceutical companies....

In contrary to adaptive design clinical trials, non-inferiority (NI) design has been there for many years (15-20 years) and many studies hav...

For last several years, 'adaptive design' and 'adaptive clinical trials' are hot topics in biostatistics and clinical trial ...

Group sequential design has been proposed for a while perhaps since Pocock's paper in 1977 . At least for last two decades, the group se...

Are you willing to take Statin medication if you have normal or mild elevation of LDL-Cholesterol level, but with elevated CRP? Last week,...

Putting a Price Tag on Life: Today, companies and governments often use Jeremy Bentham’s utilitarian logic under the name of “cost-benefit a...