ArticleEuropean journal of clinical pharmacology2020
A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials.
Article in European journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Patient, Physician, and Assessor Blinding in Phase III Randomized Trials in Oncology: A Meta-Epidemiological Analysis.Cancer medicine · 2025Pooled it
- Pembrolizumab plus chemotherapy for first-line treatment of advanced triple-negative breast cancer.Future oncology (London, England) · 2024Pooled it
- Detection bias in open-label trials of anticancer drugs: a meta-epidemiological study.BMJ evidence-based medicine · 2023Pooled it
- Main factors associated with variability in the assessment of the objective response rate. A re-analysis of the PHEREXA phase 3 clinical trial.British journal of clinical pharmacology · 2026Trial
- Setting the standard: empirical benchmarks for case-level site-central discordance in radiographic endpoints in oncology clinical trials.Contemporary clinical trials communications · 2026Article
- Survival Assessment by Central Review vs. Local Investigator in Metastatic Melanoma: A Systematic Review and Meta-Analysis.Cancers · 2026Review
- Article
- Concordance of Clinician-Documented and Imaging Response in Patients With Stage IV Non-Small Cell Lung Cancer Treated With First-Line Therapy.JAMA network open · 2022Article
- Local Investigators Significantly Overestimate Overall Response Rates Compared to Blinded Independent Central Reviews in Uncontrolled Oncology Trials: A Comprehensive Review of the Literature.Frontiers in pharmacology · 2022Review
- Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn this study, we compared the assessments of progression-free survival (PFS) carried out by the local investigator or by a blinded independent central review in the framework of phase III registration randomized controlled trials (RCT) in oncology.
methodsWe carried out a search in the clinicatrials.gov database, looking at the RCTs reporting the results of both independently assessed and investigator-assessed PFS. The hazard ratios (HRs) of investigator-assessed PFS and independently assessed PFS were recorded, and a discrepancy index was obtained by calculating the ratio of their respective HRs. Moreover, we investigated possible factors of discrepancy by analyzing the trials in different groups (by year, by tumor type, by drug type, by study design).
resultsWe analyzed 28 RCTs meeting the search criteria. The estimated mean discrepancy index was 0.98 (confidence interval 0.927-1.032 (n = 32)). Subgroup analysis showed that the confidence intervals in all cases included the value 1, except in the subgroup of studies started in the period 2003-2006.
conclusionIn phase III oncology trials, we found no significant differences between the hazard ratios estimated by local investigators and those estimated by blinded independent central reviews. A relatively higher variability, in terms of large CI, was found in trials with biological agents.
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