Saturday, October 03, 2015

How Low in Sample Size Can We Go? FDA approves ultra-orphan drug on a 4-patient trial

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The development of the orphan drugs has been red hot in recent years due to the favorable regulatory environment and the government incentiv...
Tuesday, September 15, 2015

Time to Event End Points

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Time to Event analysis has expanded beyond the traditional term of survival analysis even though the term of survival analysis may still be...
Saturday, September 05, 2015

Understanding the endpoints in oncology: overall survival, progression free survival, hazard ratio, censored value

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For clinical trials in oncology area, various terms related to the study endpoints are confusing to non-statisticians. The commonly used te...
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Saturday, August 15, 2015

Tipping point analysis - multiple imputation for stress test under missing not at random (MNAR)

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In a previous post , different imputation methods were summarized by the different missingness assumptions. One method, the tipping point a...
7 comments:
Friday, August 07, 2015

A SKEPTIC'S GUIDE TO HEALTH NEWS AND DIET FADS; A BOGUS STUDY TREATED AS REAL

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In this weekend's NPR on the media, "a skeptic's guide to health news and diet fads" was discussed. It mentioned a story ...
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Tuesday, July 28, 2015

Clinical Research Toolkit by NIH and NCI

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NIH (National Institute of Health) has been the force in conducting the landmark clinical trials and conducting the clinical trials in the...
Saturday, July 18, 2015

Dose Linearity versus Dose Proportionality

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In early phase studies of the drug development, dose linearity and dose proportionality are usually tested. It is essential to determine wh...
2 comments: