On Biostatistics and Clinical Trials

CQ's web blog on the issues in biostatistics and clinical trials.

Saturday, February 28, 2009

Liability and Indemnification of data monitoring committee members

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As stated in Demets ' paper "Liability issues for data monitoring committee members" (Clinical Trials 2004; 1: 525–531): In ra...
Friday, February 27, 2009

Confidence interval for correlation coefficient

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When we perform the correlation analysis, we typically calculate the correlation coefficient and then test if this correlation coefficient i...
Thursday, February 19, 2009

Most testing for US drug industry's late-stage human trials done outside the country, study indicates

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The Wall Street Journal (2/19, Wang) reports, "Most testing for the US drug industry's late-stage human trials is now done at site...
Saturday, February 14, 2009

Evidence-based medicine - the Evidence Gap

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New York Times had a series of articles to explore medical treatments used despite scant proof they work and examining steps toward medicine...

Cronbach's alpha - reliability coefficient

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Cronbach's Alpha is a tool for assessing the reliability of scales (for example a quality of life instrument). Cronbach's alpha can ...
Thursday, February 12, 2009

Blood plasma and serum

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Blood plasma, or plasma, is prepared by obtaining a sample of blood and removing the blood cells. The red blood cells and white blood cells ...
Thursday, February 05, 2009

DMC (Data Monitoring Committee) vs. DSMB (Data Safety Monitoring Board)

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DMC (Data Monitoring Committee) vs. DSMB (Data Safety Monitoring Board) are the same thing. The term DMC is used more now because it is the ...
Tuesday, February 03, 2009

Standard Error of Mean vs. Standard Error of Measurement

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Everybody with basic statistical knowledge should understand the differences between the standard deviation (SD) and the standard error of m...
2 comments:
Tuesday, January 20, 2009

Multiple Comparisons

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In statistics or biostatistics, the multiple comparisons problem occurs when one considers a set, or family, of statistical inferences simul...
1 comment:
Monday, January 19, 2009

Trial Biomarker Analysis More Than Data Dredging

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

Data dredging vs. Data mining; Post-hoc vs. Ad-hoc

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Data dredging (data fishing, data snooping) is the inappropriate (sometimes deliberately so) search for 'statistically significant'...
2 comments:
Sunday, January 11, 2009

EQ-5D

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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...

9 ways to stay alive when the worst happens

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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...
Tuesday, January 06, 2009

FDAAA and clinical trial data bases

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The recently-enacted FDA Amendments Act (“FDAAA”) has lots of requirements that may have impact on statistical analysis and programming. It...
Wednesday, December 31, 2008

Significance of the Correlation Coefficient

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

LogMAR in Ophthalmology trials

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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, ...
1 comment:

AstraZeneca considers pursuing "biosimilars."

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From " http://www.delawareonline.com/article/20081230/BUSINESS/812300331 " AstraZeneca is considering joining several of its peers...
Thursday, November 20, 2008

Biosimilar

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Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, fo...
Sunday, November 16, 2008

Herbal medicine

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I have been thought that the chinese traditional medicine from herbal is typically safe. However, recent discussions with my friends make me...
1 comment:
Wednesday, November 12, 2008

Analysis Problems with Subgroup Analyses

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Sub-grouping damages the balance obtained by randomization If the randomization is stratified for one factor (for example, disease severity)...
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Web blog from Dr. Deng
Chapel Hill, NC, United States
邓春勤 A Medical Doctor turned into Biostatistician in Clinical Trial and Drug Development Industry
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