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 ...
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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...
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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...
Sunday, December 06, 2020

Multiple Imputation: Imputation Model versus Analysis Model

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Multiple imputation has become more and more popular in handling the missing data in clinical trials. Multiple imputation inference involves...
Sunday, November 29, 2020

Handling of Missing Data: Comparison of MMRM (mixed model repeated measures) versus MI (multiple imputation)

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Longitudinal study has become one of the most commonly adopted designs in clinical trials. Since the outcome measures are performed at vario...
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