Sunday, September 15, 2013

‘As treated’ versus ‘As randomized’ analysis

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When we design a non-inferiority trial to support the product registration, the regulatory agencies may suggest the statistical analysis usi...
4 comments:
Monday, September 02, 2013

Fixed covariate, time dependent covariate, time varying covariate, and post-randomization covariate

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A covariate is a variable that is possibly predictive of the outcome under study. A covariate may be of direct interest or it may be a con...
Sunday, August 25, 2013

Concept of "Person Year" in daily life

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A while ago, I wrote a blog “ Understanding person-year or patient-year ”. While the concept of ‘person-year’ or ‘patient-year’ is mainly u...
Sunday, August 18, 2013

Laboratory Tests: U.S. Conventional units versus SI units and Their Conversion Factors

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In pretty much all clinical trials, laboratory tests are performed as a tool for diagnosing the disease, assessing the safety / tolerability...
2 comments:
Wednesday, July 17, 2013

Periodic Safety Report: DSUR, PSUR, PBRER, ASR, IB, Orphan Designation Annual Report

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During the drug development and after the drug is on the market, the sponsor or market authorization holder has obligations to submit the sa...
9 comments:
Friday, July 12, 2013

SOP, WP, MAPP, SOPP for FDA Internal Staff / Reviewers

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In an earlier discussion, I compared the differences between SOPs (Standard Operation Procedures) and WPs (Working Procedures). Pharmaceut...
Wednesday, July 03, 2013

Clinical Trial Regulations in European Union (EU) Countries

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For clinical trials in European Union countries, the regulations are mainly based on:   European Union (EU) clinical-trial legislation (...
3 comments:
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: