Monday, April 26, 2021

Within Patient Benefit-Risk Evaluation? Using Outcomes to Analyze Patients versus Using Patients to Analyze Outcomes?

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In our daily life, benefit-risk evaluation is something we always do whether we realize it or not. Benefit-risk evaluation is especially cri...
Monday, April 19, 2021

Restricted Mean Survival Time (RMST) for Handling the Non-Proportional Hazards Time to Event Data

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Time to event analysis (or traditionally survival analysis) is one of the most common analyses in clinical trials. In general, the time to e...
Monday, April 05, 2021

Non-proportional Hazards: how to analyze the time-to-event data?

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Time to event data is one of the most common data types in clinical trials. Traditionally, the log-rank test is used to compares the surviva...
3 comments:
Monday, March 15, 2021

Drug-related AEs, AE Causality, AE relationship, and SUSAR

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In pre-marketing clinical trials or post-marketing drug uses, adverse events (AEs) can always occur. When AEs are reported, assessments need...
2 comments:
Wednesday, March 10, 2021

Intention-to-Treat Principle versus Treatment Policy Estimand: Different Names, but Same Meaning?

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ICH E9 " Statistical Principles for Clinical Trials " was finalized in February 1998. The E9 guidelines established the Intention-...
1 comment:
Monday, February 22, 2021

Randomization Using Envelopes In Randomized, Controlled, and Blinded Clinical Trials

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I read an article by Clark et al “ Envelope use and reporting in randomized controlled trials: A guide for researchers ”. The article remind...
Monday, February 01, 2021

BLQs (below limit of quantification) and LLOQ (Lower Limit of Quantification): how to handle them in analyses?

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In data analyses of the clinical trial, one type of data is the laboratory data containing the results measured by the central laboratory or...
2 comments: