Evidence map›Paper›PMID 41206920›Full record

SynthesisThe oncologist2025

Concordance in assessments between investigators and blinded independent central review (BICR) in hematology oncology clinical trials: a meta-analysis.

Xiaoyu Tang, Yang Dang, Siying Han, Bohan Cui, Yi Kang, Xiaoyu Luo, Hui Zhang

Abstract readMeta-Analysis
In one paragraph

Synthesis in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Xiaoyu TangAcademy of Pharmacy, Xi'an Jiaotong-Liverpool University, Suzhou, Jiangsu, China.ORCID 0000-0002-7236-3201
Yang DangOncology Clinical Development, Pfizer Inc, Beijing, China.
Siying HanDepartment of Biostatistics, Boston University, Boston, Massachusetts, United States.
Bohan CuiAcademy of Pharmacy, Xi'an Jiaotong-Liverpool University, Suzhou, Jiangsu, China.
Yi KangOncology Clinical Development, Pfizer Inc, Shanghai, China.
Xiaoyu LuoAcademy of Pharmacy, Xi'an Jiaotong-Liverpool University, Suzhou, Jiangsu, China.
Hui ZhangChina Statistics, Pfizer Inc, Shanghai, China.

Funding

Research Development Fund RDF2401022Xi'an Jiaotong-Liverpool University
6 · The paper itself

Abstract

backgroundBlinded independent central review (BICR) mitigates assessment bias in oncology trials but imposes significant operational burdens. Its value in hematologic malignancies-where multimodal response criteria reduce reliance on subjective imaging assessments compared to solid tumors-remains unestablished. This meta-analysis evaluates BICR-investigator concordance specifically in hematology trials.

methodsWe systematically identified Phase II/III hematology trials (2014-2024) reporting progression-free survival (PFS) and/or objective response rate (ORR) assessments by both investigators and BICR from PubMed. Agreement was quantified using Pearson/Spearman correlation, pooled hazard ratio ratio (HRR, HRINV/HRBICR) for PFS, and odds ratio ratio for ORR (OddsRR, ORINV/ORBICR). We also analyzed the odds ratio for ORR for single arms (OddsINV/OddsBICR). Subgroup analyses assessed the impact of masking, cancer type based on imaging dependence, and sample size.

resultsData from 70 studies (37 PFS comparisons; 23 ORR comparisons; 29 single-arm ORR) were analyzed. For PFS, the pooled HRR was 0.96 (95% CI: 0.89, 1.03), with perfect agreement in statistical significance (Cohen's kappa = 1). For ORR, the pooled OddsRR was 0.99 (95% CI: 0.85, 1.14). Single-arm trials showed minimal odds difference between assessors (OR = 1.02, 95% CI: 0.90, 1.17). Subgroup analyses (masking, cancer type, sample size) consistently showed high agreement.

conclusionsInvestigator and BICR assessments demonstrated substantial concordance in hematology trials. The common applications of BICR in registration trials provide minimal added value for primary endpoint validation in this setting. We recommend prioritizing investigator training and standardized criteria to optimize resource allocation.

Indexed as

Hematologic NeoplasmsMedical OncologyClinical Trials as TopicHumansblinded independent central reviewclinical trialshematologyobjective response ratesprogression free survivaltumor assessments

Identifiers

PMID41206920
PMCPMC12622372

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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.