Evidence map›Paper›PMID 36977709›Full record

ArticleScientific reports2023

A novel model of the continual reassessment method in Phase I trial.

Weijia Zhang, Wanni Lei, Xiaojun Zhu

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Article in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

3 authors.

Weijia ZhangCenter of Statistical Research and School of Statistics, Southwestern University of Finance and Economics, Chengdu, 611130, Sichuan, China.
Wanni LeiDepartment of Applied Mathematics, Xi'an Jiaotong-Liverpool University, Suzhou, 215123, Jiangsu, China. wannilei@163.com.
Xiaojun ZhuDepartment of Financial and Actuarial Mathematics, Xi'an Jiaotong-Liverpool University, suzhou, 215123, Jiangsu, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

For the model-based designs, the continual reassessment method (CRM) is widely used to identify the maximum tolerated dose (MTD) in phase I clinical trials. To improve the performance of classic CRM models, we propose a new CRM and its dose-toxicity probability function based on the Cox model whatever the treatment response is immediately observed or delayed. In the process of dose-finding trial, we can use our model in situations when either the response is delayed or not and can derive the likelihood function and posterior mean toxicity probabilities to find the MTD. Simulation is carried out to evaluate the performance of the proposed model with the classic CRM models. We also evaluate the operating characteristics of the proposed model by the Efficiency, Accuracy, Reliability, and Safety (EARS) criteria.

Indexed as

Clinical Trials, Phase I as TopicResearch DesignBayes TheoremComputer SimulationDose-Response Relationship, DrugLikelihood FunctionsReproducibility of Results

Identifiers

PMID36977709
PMCPMC10050314

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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.