Evidence map›Paper›PMID 33257221›Full record

ArticleUrologic oncology2021

Estimating the rate and reasons of clinical trial failure in urologic oncology.

Kristian D Stensland, Krystal DePorto, James Ryan, Samuel Kaffenberger, Lael S Reinstatler, Matthew Galsky, David Canes, Ted A Skolarus, Alireza Moinzadeh

Abstract read
In one paragraph

Article in Urologic oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Article
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  7. Observational
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  10. Microfluidic-based human prostate-cancer-on-chip.Frontiers in bioengineering and biotechnology · 2024
    Article
  11. Article
  12. Interventions to improve access to clinical trials in urologic oncology.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023
    Article
  13. Article
  14. Article
  15. 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

9 authors.

Kristian D StenslandDepartment of Urology, University of Michigan, Ann Arbor, MI; Lahey Hospital and Medical Center, Burlington, MA. Electronic address: kstens@med.umich.edu.
Krystal DePortoTufts University School of Medicine, Boston, MA.
James RyanTufts University School of Medicine, Boston, MA.
Samuel KaffenbergerDepartment of Urology, University of Michigan, Ann Arbor, MI.
Lael S ReinstatlerDartmouth-Hitchcock Medical Center, Lebanon, NH.
Matthew GalskyTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
David CanesLahey Hospital and Medical Center, Burlington, MA.
Ted A SkolarusDepartment of Urology, University of Michigan, Ann Arbor, MI.
Alireza MoinzadehLahey Hospital and Medical Center, Burlington, MA.

Funding

Advanced Training in Urologic OncologyT32CA180984 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Ganesh S Palapattu, VAHAKN B SHAHINIAN · 2014 to 2026
$3.4M
NCI NIH HHS T32 CA180984
6 · The paper itself

Abstract

objectivesClinical trials are pillars of modern clinical evidence generation. However, the clinical trial enterprise can be inefficient, and trials often fail before their planned endpoint is reached. We sought to estimate how often urologic oncology trials fail, why trials fail, and associations with trial failure.

methodsWe queried phase 2/3 urologic clinical trial data from ClinicalTrials.gov registered between 2007 and 2019, with status marked as active, completed, or terminated. We extracted relevant trial data, including anticipated and actual accrual, from trial records and ClinicalTrials.gov archives. We manually coded reasons given in the "why stopped" free text field for trial failure into categories (poor accrual, interim results, toxicity/adverse events, study agent unavailable, canceled by the sponsor, inadequate budget, logistics, trial no longer needed, principal investigator left, no reason given, or other). We considered trials terminated for safety or efficacy to be completed trials. Trials marked as terminated for other reasons were considered failed trials. We then estimated the rate of trial failure using competing risks methods. Finally, we assessed associations with trial failure using a Cox proportional hazards model.

resultsA total of 1,869 urologic oncology trials were included. Of these, 225 (12.0%) failed, and 51 (2.7%) were terminated for "good" reasons (e.g., toxicity, efficacy). Of the 225 failed trials, 122 (54%) failed due to poor accrual. Failed trials had a lower anticipated accrual than successfully completed trials (55 vs. 63 patients, P<0.001). A total of 6,832 patients were actually accrued to failed trials. The 10-year estimated risk of trial failure was 17% (95% CI 15%-22%). Single center trials, phase 3 trials, drug trials, and trials with exclusively USA sites were more likely to fail.

conclusionWe estimate that 17%, or roughly 1 in 6, of urologic oncology trials fail, most frequently for poor accrual. Further investigations are needed into systemic, trial, and site-specific factors that may impact accrual and successful trial completion.

Indexed as

Clinical Trials as TopicEarly Termination of Clinical TrialsHumansUrologic NeoplasmsClinical trialsEvidence generationTrial accrual

Identifiers

PMID33257221
PMCPMC7902467

What OpenQuestion holds

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Registered trials

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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.