Evidence map›Paper›PMID 36806713›Full record

ArticleJNCI cancer spectrum2023

Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria.

Andrea N Riner, Devon C Freudenberger, Kelly M Herremans, Vignesh Vudatha, Daniel W Neal, Thomas J George, Jose G Trevino

Abstract read
In one paragraph

Article in JNCI cancer spectrum, 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
–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

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Health Inequities in Pancreatic Disorders in the Black/African American Community.Journal of racial and ethnic health disparities · 2026
    Review
  4. Article
  5. Challenges to and considerations of designing cancer prevention trials.Journal of the National Cancer Institute. Monographs · 2025
    Article
  6. Review
  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

7 authors.

Andrea N RinerDepartment of Surgery, University of Florida College of Medicine, Gainesville, FL, USA.ORCID 0000-0003-2088-5400
Devon C FreudenbergerDepartment of Surgery, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.ORCID 0000-0002-9117-0130
Kelly M HerremansDepartment of Surgery, University of Florida College of Medicine, Gainesville, FL, USA.ORCID 0000-0002-0454-0931
Vignesh VudathaDepartment of Surgery, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.ORCID 0000-0002-3624-3771
Daniel W NealDepartment of Surgery, University of Florida College of Medicine, Gainesville, FL, USA.
Thomas J GeorgeDepartment of Medicine, Division of Hematology and Oncology, University of Florida College of Medicine, Gainesville, FL, USA.ORCID 0000-0002-6249-9180
Jose G TrevinoDepartment of Surgery, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.ORCID 0000-0003-3149-7761

Funding

Tissue Modeling & Drug Development Shared Resources CoreU54CA233444 · NCI · UNIVERSITY OF FLORIDA · PI JI-HYUN LEE · 2018 to 2026
$12.1M
Training Program for Applied Research and Development in Genomic MedicineT32HG008958 · NHGRI · UNIVERSITY OF FLORIDA · PI Larisa Humma Cavallari, Stephen E. Kimmel · 2018 to 2026
$3.8M
Training Program in Cancer Prevention and Control and Cancer Health Equity (CPC-CHE)T32CA093423 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI Bernard F Fuemmeler, Oxana G Palesh · 2018 to 2026
$3.0M
Use of BCL-xL Proteolysis targeting chimeras to treat pancreatic cancerR01CA242003 · NCI · UNIVERSITY OF FLORIDA · PI TREVINO, JOSE G., ZHENG, GUANGRONG · 2019 to 2023
$2.6M
NCI NIH HHS R01 CA242003NCI NIH HHS T32 CA093423NCI NIH HHS U54 CA233444NHGRI NIH HHS T32 HG008958
6 · The paper itself

Abstract

Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014, were identified via clinicaltrials.gov with December 31, 2017, as the transition for pre- and postguidance eras. Trials were assessed for guideline compliance and compared using Fisher exact test. In total, 198 trials were identified: 86 (43.4%) were pre- and 112 (56.6%) postguidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs 43.8%; P < .0001), prior cancer (57.0% vs 72.3%; P = .034), or concurrent and/or stable cancer (2.1% vs 31.1%; P < .0001) to participate. Most (>95%) trials were compliant with laboratory reference ranges, QT interval corrected for heart rate (QTc) cutoffs, and rationalizing excluding prior therapies both pre- and postguidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.

Indexed as

Pancreatic NeoplasmsResearch DesignEligibility DeterminationHumansPatient SelectionUnited States

Identifiers

PMID36806713
PMCPMC9978314

What Socratic 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 Socratic graph.