Evidence map›Paper›PMID 42347610›Full record

ArticleVaccines2026

Data-Driven Vaccine Clinical Trial Design Features and Associated Progress Patterns: An Analysis of 1618 Clinical Trials from 2012 to 2022.

Siyang Chan, Dachuang Zhou, Di Zhang, Yuting Xia, Wenxi Tang

Abstract read
In one paragraph

Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Siyang ChanCenter for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing 211198, China.ORCID 0009-0002-0093-7410
Dachuang ZhouCenter for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing 211198, China.
Di ZhangCenter for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing 211198, China.
Yuting XiaCenter for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing 211198, China.
Wenxi TangCenter for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing 211198, China.ORCID 0000-0002-3564-3626

Funding

National Natural Science Foundation of China 2023YFVA1002
6 · The paper itself

Abstract

BACKGROUND/

objectivesVaccine clinical trials face high costs, long timelines, and variable progression rates, yet systematic evidence linking trial design features to progression outcomes remains limited. This study aimed to identify trial design features associated with vaccine trial progression and to explore robust design configurations using machine learning approaches.

methodsWe analyzed 1618 vaccine trials registered from 2012 to 2022. Progression was defined as phase advancement (phase I/II) or regulatory authorization (phase III). Logistic regression assessed associations with progression. Random forest classifiers with cross-validation were used to estimate predicted progression probabilities based on combinations of design features. Monte Carlo simulations compared model-identified robust configurations with randomly generated configurations.

resultsAmong 1618 trials, 579 achieved phase progressions, corresponding to an overall observed progression rate of 35.8%. Larger sample size, preventive vaccine purpose, COVID-19 indication, and enrollment across all age groups were consistently associated with higher observed odds of progression in both univariable and multivariable logistic regression analyses. In machine learning analyses, the pooled mean predicted progression probability of model-identified robust configurations was 48.93%, compared with 39.44% for historically observed design configurations, corresponding to a relative increase of 24.1%. Simulations further showed a lower projected cumulative development duration (106.87 vs. 128.25 months; -16.7%) and reduced projected cost (USD 100.67M vs. USD 108.33M; -7.1%) for robust configurations compared with historical strategies.

conclusionsThis study provides a data-driven framework for characterizing historical vaccine trial design patterns. By integrating machine learning with observational registry data, it supports hypothesis generation and descriptive benchmarking of design features that may inform the design of future prospective or causal investigations.

Indexed as

clinical developmentevidence-based designmachine learningR&D efficiencytrial success determinantsvaccine trials

Identifiers

PMID42347610
PMCPMC13307709

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.