Evidence map›Paper›PMID 30206071›Full record

ReviewBMJ open2018

Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour.

Jianrong Zhang, Yiyin Zhang, Shiyan Tang, Long Jiang, Qihua He, Lindsey Tristine Hamblin, Jiaxi He, Zhiheng Xu, Jieyu Wu, Yaoqi Chen and 11 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 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.

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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Upfront Modified FOLFOXIRI Plus Panitumumab forJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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  9. Article
  10. What Is Ailing Oncology Clinical Trials? Can We Fix Them?Current oncology (Toronto, Ont.) · 2024
    Review
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  14. Review
  15. Article
  16. Article
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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

21 authors.

Jianrong Zhang *Department of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.ORCID 0000-0003-4688-5222
Yiyin Zhang *Nanshan School, Guangzhou Medical University, Guangzhou, China.
Shiyan Tang *Nanshan School, Guangzhou Medical University, Guangzhou, China.
Long JiangDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Qihua HeDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Lindsey Tristine HamblinDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jiaxi HeDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Zhiheng XuGuangzhou Institute of Respiratory Disease & China State Key Laboratory of Respiratory Disease, Guangzhou, China.
Jieyu WuDepartment of Pathology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yaoqi ChenDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Hengrui LiangNanshan School, Guangzhou Medical University, Guangzhou, China.
Difei ChenNanshan School, Guangzhou Medical University, Guangzhou, China.
Yu HuangNanshan School, Guangzhou Medical University, Guangzhou, China.
Xinyu WangNanshan School, Guangzhou Medical University, Guangzhou, China.
Kexin DengNanshan School, Guangzhou Medical University, Guangzhou, China.
Shuhan JiangNanshan School, Guangzhou Medical University, Guangzhou, China.
Jiaqing ZhouNanshan School, Guangzhou Medical University, Guangzhou, China.
Jiaxuan XuNanshan School, Guangzhou Medical University, Guangzhou, China.
Xuanzuo ChenNanshan School, Guangzhou Medical University, Guangzhou, China.
Wenhua LiangDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.ORCID 0000-0002-1391-8238
Jianxing HeDepartment of Thoracic Surgery and Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveUnbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. The aim of this study is to investigate whether systematic bias existed in RCTs by comparing the treatment effects of efficacy endpoints between central and local assessments.

designLiterature review, pooling analysis and correlation analysis. DATA SOURCES: PubMed, from 1 January 2010 to 30 June 2017. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Eligible articles are phase III RCTs comparing anticancer agents for advanced solid tumours. Additionally, the articles should report objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) or time to progression (TTP); the treatment effect of these endpoints, OR or HR, should be based on central and local assessments.

resultsOf 76 included trials involving 45 688 patients, 17 (22%) trials reported their endpoints with statistically inconsistent inferences (p value lower/higher than the probability of type I error) between central and local assessments; among them, 9 (53%) trials had statistically significant inference based on central assessment. Pooling analysis presented no systematic bias when comparing treatment effects of both assessments (ORR: OR=1.02 (95% CI 0.97 to 1.07), p=0.42, I

conclusionsNo systematic bias could be found between local and central assessments in phase III RCTs on solid tumours. However, statistically inconsistent inferences could be made in many trials between both assessments.

Indexed as

BiasStatistics as TopicTreatment OutcomeClinical Trials, Phase III as TopicHumansNeoplasmsRandomized Controlled Trials as Topicblind independent central reviewlocal assessmentoncological randomized control trials

Identifiers

PMID30206071
PMCPMC6144327

What OpenQuestion holds

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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.