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Validity and power of minimization algorithm in longitudinal analysis of clinical trials
Weng H, Bateman R, Morris JC, Xiong C.. Biostatistics & epidemiology, 2017-06-13
Topic: Risk, prevention and care in population studies
We studied the validity of longitudinal statistical inferences of clinical trials using minimization, a dynamic randomization algorithm designed to minimize treatment imbalance for prognostic factors. Repeated measures analysis of covariance and the random intercept and slope models, were used to simulate longitudinal clinical trials randomized by minimization or simple randomization. The simulations represented a wide range of analyses in real-world trials, including missing data caused by dropouts, unequal allocation of treatment arms, and efficacy analyses on either the original outcome or its change from baseline. We also analyzed the database from the Dominantly Inherited Alzheimer Network (DIAN), and used the estimated parameters to simulate the ongoing DIAN trial. Our analyses demonstrated minimization had conservative type I errors when the prognostic factor used in the minimization algorithm had a relatively strong correlation with the outcome and was not adjusted for in analyses. In contrast, adjusted tests for the prognostic factor as a covariate resulted in type I errors close to the nominal significance level. In many simulation scenarios, the adjusted tests using minimization had slightly greater statistical power than those using simple randomization, whereas in the other scenarios, the power of adjusted tests using these two randomization methods are almost indistinguishable.
Key findings
- Our analyses demonstrated minimization had conservative type I errors when the prognostic factor used in the minimization algorithm had a relatively strong correlation with the outcome and was not adjusted for in analyses.
Why it matters
This is a statistical methods study about a randomization technique called minimization, not a test of any Alzheimer's treatment. It found that when a prognostic factor strongly related to the outcome was not adjusted for, the analysis gave conservative error rates, and that adjusting for it brought error rates close to the intended level.
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Study details
- Study designlongitudinal study
- Evidence strengthHigh
How this study scored 42/100
Published in a peer-reviewed journal, and it is a longitudinal study following the same people over time. Scored zero for sample size, effect reported, studied in people and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Biostatistics & epidemiology) |
| Journal's citation record | 0 / 4 | Biostatistics & Epidemiology: journal h-index 13 (OpenAlex, 2026-10-29) |
| Study design | 7 / 12 | A longitudinal study following the same people over time |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2017 — within 10 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 2 / 7 | Cited 6 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.5 citations a year over 11 year(s) since 2017 |
| Impact for its field and year | 1 / 6 | Cited 0.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 3 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Chengjie Xiong: h-index 60 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Washington University in St. Louis: institution h-index 1,962 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 29250611) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 42 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1080/24709360.2017.1331822
- PubMed: 29250611
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Weng, H., Bateman, R., Morris, J. C., & Xiong, C. (2017). Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostatistics & epidemiology. https://doi.org/10.1080/24709360.2017.1331822
Vancouver
Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostatistics & epidemiology. 2017. doi:10.1080/24709360.2017.1331822. PMID: 29250611.
BibTeX
@article{weng2017-29250611,
author = {Weng, H. and Bateman, R. and Morris, J. C. and Xiong, C.},
title = {{Validity and power of minimization algorithm in longitudinal analysis of clinical trials}},
journal = {Biostatistics \& epidemiology},
year = {2017},
doi = {10.1080/24709360.2017.1331822},
pmid = {29250611},
url = {https://doi.org/10.1080/24709360.2017.1331822}
}
Studies this one cites
Referenced by this study and also in the alzhub library, so you can read them here.