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:
Sunday, January 17, 2021

Arithmetic mean, geometric mean, harmonic mean, least square mean, and trimmed mean

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In statistics, a central tendency is a central or typical value for data distribution. Mean (or average) is commonly used to measure the cen...
Monday, January 11, 2021

Single Imputation Methods for Missing Data: LOCF, BOCF, LRCF (Last Rank Carried Forward), and NOCB (Next Observation Carried Backward)

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The missing data is always an issue when analyzing the data from clinical trials. The missing data handling has been moved toward the model-...
Monday, January 04, 2021

Synthetic Control Arm (SCA), External Control, Historical Control

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Lately, the term 'synthetic control' or 'synthetic control arm' or SCA, in short, is becoming popular - it is mainly driven ...
1 comment:
Monday, December 28, 2020

120-Day Safety Update or 4-Month Safety Update - The Requirement for NDA/BLA

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After the new drug application (NDA) or biological license application (BLA) is submitted by the sponsor and is accepted by FDA, FDA reviewe...
2 comments:
Tuesday, December 08, 2020

COA (Clinical Outcome Assessment): PRO, ClinRO, PerfRO, ObsRO, eCOA, and TECOA

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Clinical Outcome Assessment (COA) has triggered multiple acronyms: PRO, ClinRO, PerfRO, and ObsRO According to FDA's website , these acr...