ArticleThe journal of pathology. Clinical research2019
Quality assurance guidance for scoring and reporting for pathologists and laboratories undertaking clinical trial work.
Article in The journal of pathology. Clinical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 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
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Amputation for Complex Regional Pain Syndrome: Meta-Analysis and Validation of a Histopathology Scoring System.Pain medicine (Malden, Mass.) · 2023Pooled it
- Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta-aggregation.The journal of pathology. Clinical research · 2021Pooled it
- Why early pathology input matters in biologically rich cancer trials.British journal of cancer · 2026Review
- The role of the pathologist in the design and conducting of biomarker-driven clinical trials in cancer: position paper of the European Society of Pathology.Virchows Archiv : an international journal of pathology · 2025Review
- Intra-prostatic tumour evolution, steps in metastatic spread and histogenomic associations revealed by integration of multi-region whole-genome sequencing with histopathological features.Genome medicine · 2024Article
- Assessment of clinical trial protocols for pathology content using the SPIRIT-Path guidelines highlights areas for improvement.The journal of pathology. Clinical research · 2022Article
- HPV sensitizes OPSCC cells to cisplatin-induced apoptosis by inhibiting autophagy through E7-mediated degradation of AMBRA1.Autophagy · 2021Article
- Digital pathology and artificial intelligence will be key to supporting clinical and academic cellular pathology through COVID-19 and future crises: the PathLAKE consortium perspective.Journal of clinical pathology · 2021Review
- PD-L1 as a biomarker of response to immune-checkpoint inhibitors.Nature reviews. Clinical oncology · 2021Review
- The Potential of Artificial Intelligence to Detect Lymphovascular Invasion in Testicular Cancer.Cancers · 2021Article
- Quality Assessment Across Disciplines in Head and Neck Cancer Treatment Diagnostic Pathology in HNSCC.Frontiers in oncology · 2020Review
- Training and accreditation standards for pathologists undertaking clinical trial work.The journal of pathology. Clinical research · 2019Article
- The use of digital pathology and image analysis in clinical trials.The journal of pathology. Clinical research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 13 institutions in 1 country.
Funding
Abstract
While pathologists have always played a pivotal role in clinical trials ensuring accurate diagnosis and staging, pathology data from prognostic and predictive tests are increasingly being used to enrol, stratify and randomise patients to experimental treatments. The use of pathological parameters as primary and secondary outcome measures, either as standalone classifiers or in combination with clinical data, is also becoming more common. Moreover, reporting of estimates of residual disease, termed 'pathological complete response', have been incorporated into neoadjuvant clinical trials. Pathologists have the expertise to deliver this essential information and they also understand the requirements and limitations of laboratory testing. Quality assurance of pathology-derived data builds confidence around trial-specific findings and is necessarily focused on the reproducibility of pathological data, including 'estimates of uncertainty of measurement', emphasising the importance of pathologist education, training, calibration and demonstration of satisfactory inter-observer agreement. There are also opportunities to validate objective image analysis tools alongside conventional histological assessments. The ever-expanding portfolio of clinical trials will demand more pathologist engagement to deliver the reliable evidence-base required for new treatments. We provide guidance for quality assurance of pathology scoring and reporting in clinical trials.
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What OpenQuestion holds
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.