Evidence map›Paper›PMID 30068783›Full record

ArticleThe oncologist2018

Premature Clinical Trial Discontinuation in the Era of Immune Checkpoint Inhibitors.

Monica Khunger, Sagar Rakshit, Adrian V Hernandez, Vinay Pasupuleti, Kate Glass, Matthew D Galsky, Petros Grivas

Abstract read
In one paragraph

Article in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Interventions to improve access to clinical trials in urologic oncology.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023
    Article
  9. Applying implementation frameworks to the clinical trial context.Implementation science communications · 2022
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. 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.

Monica KhungerDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio, USA.ORCID 0000-0001-8399-9945
Sagar RakshitDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
Adrian V HernandezUniversity of Connecticut/Hartford Hospital Evidence-based Practice Center, Hartford, Connecticut, USA.
Vinay PasupuletiProEd Communications Inc., Cleveland, Ohio, USA.
Kate GlassTaussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Matthew D GalskyDepartment of Hematology/Oncology, Icahn School of Medicine, Mount Sinai, New York, New York, USA.
Petros GrivasDepartment of Medicine, Division of Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington, USA pgrivas@uw.edu.ORCID 0000-0003-3965-3394

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trial completion is critical for new cancer therapies. Premature trial termination or withdrawal is common and impairs progress. We assessed factors of early terminated/withdrawn oncology trials focusing on trials with immune checkpoint inhibitors (ICI), hypothesizing that the latter may be associated with lower rates of premature discontinuation. MATERIALS AND

methodsWe reviewed all adult, intervention, oncology trials registered in ClinicalTrials.gov (November 16, 2011, to April 16, 2015) to identify all terminated/withdrawn trials and reasons for termination. Logistics regression model was used to identify factors associated with early termination/withdrawal. Discontinuation rate was compared in trials with and without ICI.

resultsWe identified 12,875 trials (35% industry funded, 12% federal funded), of which 8.5% were prematurely terminated (5%) or withdrawn (3.5%); the main reasons were poor accrual (33%) and logistical (24%). ICI trials (

conclusionPoor accrual represents the main cause of early cancer trial termination. Premature termination/withdrawal rate was not significantly lower in ICI compared with other trials. Clinical trial completion remains a high priority and can be influenced by provider and patient factors. IMPLICATIONS FOR PRACTICE: Clinical trial completion is critical for new cancer therapies. Premature trial termination or withdrawal is common and impairs progress. This study assessed factors of early terminated/withdrawn oncology trials, focusing on trials with immune checkpoint inhibitors (ICI), and found that poor accrual represents the main cause of early cancer trial termination. Premature termination/withdrawal rate was not significantly lower in immune checkpoint inhibitor trials compared to other trials. The discussion herein is focused on measures taken by the National Cancer Institute and other institutions to improve clinical trial accrual and prevent premature clinical trial discontinuation.

Indexed as

Clinical Trials as TopicHumansImmunotherapyPatient SelectionCancerClinical researchClinical trial terminationImmune checkpoint inhibitorsImmunotherapy

Identifiers

PMID30068783
PMCPMC6292544

What OpenQuestion holds

Textmetadata
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.