Cited by 63Statistical Methods and Bayesian InferenceStatistical Methods in Clinical TrialsPharmaceutical studies and practices

MMRM versus MI in Dealing with Missing Data—A Comparison Based on 25 NDA Data Sets

Siddiqui, Ohidul·2011·Journal of Biopharmaceutical Statistics

Abstract

Both multiple imputation (MI) and mixed-effects model repeated measures (MMRM) approaches appear to be better choices than the traditional last-observation-carried-forward (LOCF) approach in analyzing incomplete clinical trial data sets in drug development research. However, relative performances of these two approaches are unknown in controlling type I error rate and statistical power in the hypothesis testing of determining the efficacy of an investigational drug. Little research has been done in comparing robustness of the two approaches in analyzing ignorable missing data of clinical trials. In this research, a comparison between the MI and MMRM approaches is made in analyzing the simulated incomplete data sets and 25 New Drug Application (NDA) data sets of neuropsychiatric drug products. The MMRM approach appears to be a better choice in maintaining statistical properties of a test as compared to the MI approach in dealing with ignorable missing data of clinical trials.

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Crossref · 10.1080/10543401003777995

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Authors
Siddiqui, O.
Affiliations
United States Food and Drug Administration (US)
Corresponding author
Siddiqui, Ohidul
Venue
Journal of Biopharmaceutical Statistics
Published
2011-03-24
Volume
21
Issue
3
Pages
423-436
ISSN
  • 1054-3406 (ISSN-L)
  • 1520-5711
OpenAlex
W2050266605
Cited by
63
References
37
Citations by year
2026: 6 · 2025: 8 · 2024: 7 · 2023: 5 · 2022: 4 · 2021: 2 · 2020: 4 · 2019: 5 · 2018: 4 · 2017: 5 · 2016: 2 · 2015: 3 · 2014: 5 · 2013: 2 · 2012: 1
FWCI
2.24
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Biopharmaceutical Statistics (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
multiple imputation, missing data, last observation carried forward, type I error rate, statistical power, neuropsychiatric drugs, drug efficacy testing
MeSH terms
Clinical Trials as Topic, Computer Simulation, Humans, Patient Dropouts, Regression Analysis, Research Design, Models, Statistical, Drugs, Investigational, Randomized Controlled Trials as Topic

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