On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Sunday, June 23, 2013
Serious Adverse Event (SAE) Data Collection / Reporting Using Electronic Data Capture (EDC) System
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Clinical trials require ongoing and continuous monitoring of the safety for study participants. According to 21 CFR 312.64 , Investigators ...
One-Sided Test in A Superiority Trial
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In this year’s ATS meeting, the results for a study “ Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor (API) Defici...
2 comments:
Sunday, June 16, 2013
Drug for Treating Rare Diseases: Orphan Drug, Orphan Disease, Orphan Subset
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Section 526(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) defines a ‘‘rare disease or condition’’ as following: any dis...
1 comment:
Monday, May 27, 2013
The Size of Safety Database In Drug Development Program
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In planning the clinical program for drug approval, in addition to the efficacy assessment, the adequate size of the safety database is usu...
4 comments:
Monday, May 20, 2013
Biomarkers versus Surrogate Endpoints
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“Biomarkers” and “Surrogate endpoints” are closely related, a lthough a biomarker can serve as a surrogate endpoint, the terms of biomarker...
Sunday, April 28, 2013
Age Calculation in Clinical Trial Data Analysis with SAS Examples
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In clinical trials, subject’s age is a critical demographic variable that needs to be collected. Age may be used in checking the inclusion...
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