Evidence map›Paper›PMID 32434577›Full record

ArticleBMC medical research methodology2020

Optimal, minimax and admissible two-stage design for phase II oncology clinical trials.

Fei Qin, Jingwei Wu, Feng Chen, Yongyue Wei, Yang Zhao, Zhiwei Jiang, Jianling Bai, Hao Yu

Registry-linked trialAbstract read
In one paragraph

Article in BMC medical research methodology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06923488 (Phase I/II Study of Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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.

NCT06923488 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Phase I/II Study of Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

TypeinterventionalSponsorWest Virginia UniversityRan2025 to 2028Enrolled26ConditionsMyelodysplastic SyndromesArmsLeflunomide 10mg, Leflunomide 20mg, Decitabine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  4. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Trial
  5. Trial
  6. Review
  7. Article
  8. Article
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

8 authors.

Fei QinDepartment of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Jingwei WuDepartment of Epidemiology and Biostatistics, College of Public Health, Temple University, Philadelphia, PA, USA.
Feng ChenDepartment of Biostatistics, School of Public Health, Nanjing Medical University, SPH Building Room 418, 101 Longmian Avenue, Nanjing, 211166, Jiangsu, China.
Yongyue WeiDepartment of Biostatistics, School of Public Health, Nanjing Medical University, SPH Building Room 418, 101 Longmian Avenue, Nanjing, 211166, Jiangsu, China.
Yang ZhaoDepartment of Biostatistics, School of Public Health, Nanjing Medical University, SPH Building Room 418, 101 Longmian Avenue, Nanjing, 211166, Jiangsu, China.
Zhiwei JiangBeijing KeyTech Statistical Consulting Co., Ltd, Beijing, China.
Jianling BaiDepartment of Biostatistics, School of Public Health, Nanjing Medical University, SPH Building Room 418, 101 Longmian Avenue, Nanjing, 211166, Jiangsu, China. jbai@njmu.edu.cn.ORCID 0000-0003-3678-2879
Hao YuDepartment of Biostatistics, School of Public Health, Nanjing Medical University, SPH Building Room 418, 101 Longmian Avenue, Nanjing, 211166, Jiangsu, China. haoyu@njmu.edu.cn.

Funding

National Natural Science Foundation of China 81773554the National Natural Science Foundation of China Grant for Young Scientists 81302512
6 · The paper itself

Abstract

backgroundThe article aims to compare the efficiency of minimax, optimal and admissible criteria in Simon's and Fleming's two-stage design.

methodsThree parameter settings (p

resultsIn both Simon's and Fleming's two-stage designs, the maximum sample size of admissible design is smaller than optimal design but larger than minimax design. Meanwhile, the expected samples size of admissible design is smaller than minimax design but larger than optimal design. Mostly, the maximum sample size and expected sample size in Fleming's designs are considerably smaller than that of Simon's designs.

conclusionsWhenever (p

Indexed as

NeoplasmsResearch DesignClinical Trials, Phase II as TopicHumansMedical OncologyProbabilitySample SizeAdmissible designMinimax designOptimal design

Identifiers

PMID32434577
PMCPMC7240995

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Registered trials

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.