Evidence map›Paper›PMID 37400830›Full record

ArticleBMC medicine2023

Eligibility criteria in clinical trials in breast cancer: a cohort study.

Katarzyna Szlezinger, Katarzyna Pogoda, Agnieszka Jagiełło-Gruszfeld, Danuta Kłosowska, Andrzej Górski, Jan Borysowski

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
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

8 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
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

6 authors at 3 institutions in 1 country.

Katarzyna SzlezingerPharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222, Warsaw, Poland.
Katarzyna PogodaDepartment of Breast Cancer and Reconstruction Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Roentgena 5, 02-781, Warsaw, Poland.
Agnieszka Jagiełło-GruszfeldDepartment of Breast Cancer and Reconstruction Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Roentgena 5, 02-781, Warsaw, Poland.
Danuta KłosowskaDepartment of Clinical Immunology, Medical University of Warsaw, Nowogrodzka 59, 02-006, Warsaw, Poland.
Andrzej GórskiBacteriophage Laboratory, Department of Phage Therapy, Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Rudolfe Weigla 12, 53-114, Wrocław, Poland.
Jan BorysowskiDepartment of Clinical Immunology, Medical University of Warsaw, Nowogrodzka 59, 02-006, Warsaw, Poland. jan.borysowski@wum.edu.pl.
Medical University of Warsaw · PLThe Maria Sklodowska-Curie National Research Institute of Oncology · PLLudwik Hirszfeld Institute of Immunology and Experimental Therapy · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBreast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status.

methodsData on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression.

resultsOur analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older.

conclusionsMany recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice.

Indexed as

Breast NeoplasmsAgedCohort StudiesComorbidityFemaleHumansBreast cancerClinical trialComorbidityElderlyEligibility criteriaEnrollment criteriaExclusion criteriaOlder adultPerformance status

Identifiers

PMID37400830
PMCPMC10318672
OpenAlexW4382987494

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.