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Record W4413114376 · doi:10.1002/pst.70037

Drift Parameter Based Sample Size Determination in Multi‐Stage Bayesian Randomized Clinical Trials

2025· article· en· W4413114376 on OpenAlexafffund
Yueyang Han, Haolun Shi, Jiguo Cao, Ruitao Lin

Bibliographic record

VenuePharmaceutical Statistics · 2025
Typearticle
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsSimon Fraser University
FundersNatural Sciences and Engineering Research Council of Canada
KeywordsSample size determinationBayesian probabilityStatisticsStage (stratigraphy)Randomized controlled trialClinical trialMathematicsComputer scienceEconometricsMedicineInternal medicineBiology

Abstract

fetched live from OpenAlex

Sample size determination in Bayesian randomized phase II trial design often relies on computationally intensive search methods, presenting challenges in terms of feasibility and efficiency. We propose a novel approach that greatly reduces the computing time of sample size calculations for Bayesian trial designs. Our approach innovatively connects group sequential design with Bayesian trial design and leverages the proportional relationship between sample size and the squared drift parameter. This results in a faster algorithm. By employing regression analysis, our method can accurately pinpoint the required sample size with significantly reduced computational burden. Through theoretical justification and extensive numerical evaluations, we validate our approach and illustrate its efficiency across a wide range of common trial scenarios, including binary endpoint with Beta-Binomial model, normal endpoint, binary/ordinal endpoint under Bayesian generalized linear model, and survival endpoints under Bayesian piecewise exponential models. To facilitate the use of our methods, we create an R package named "BayesSize" on GitHub.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.080
metaresearch head score (Gemma)0.206
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Simulation or modeling · Consensus signal: none
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.920
Threshold uncertainty score0.421

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0800.206
Meta-epidemiology (narrow)0.0010.002
Meta-epidemiology (broad)0.0030.002
Bibliometrics0.0030.002
Science and technology studies0.0010.003
Scholarly communication0.0020.003
Open science0.0040.004
Research integrity0.0030.005
Insufficient payload (model declined to judge)0.0070.002

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.761
GPT teacher head0.692
Teacher spread0.069 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designSimulation or modeling
DomainMethods
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2025
Admission routes2
Has abstractyes

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