Evidence map›Paper›PMID 33547324›Full record

ArticleNature communications2021

The effects of releasing early results from ongoing clinical trials.

Steffen Ventz, Sergio Bacallado, Rifaquat Rahman, Sara Tolaney, Jonathan D Schoenfeld, Brian M Alexander, Lorenzo Trippa

Abstract read
In one paragraph

Article in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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.

Steffen VentzDana-Farber Cancer Institute, Harvard T.H. Chan School of Public Health, Boston, MA, USA. steffen@jimmy.harvard.edu.ORCID 0000-0003-2229-9560
Sergio BacalladoUniversity of Cambridge, Cambridge, UK.
Rifaquat RahmanDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Sara TolaneyDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-5940-8671
Jonathan D SchoenfeldDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Brian M AlexanderDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Lorenzo TrippaDana-Farber Cancer Institute, Harvard T.H. Chan School of Public Health, Boston, MA, USA.

Funding

Medical Research Council MR/P01710X/1
6 · The paper itself

Abstract

Most trials do not release interim summaries on efficacy and toxicity of the experimental treatments being tested, with this information only released to the public after the trial has ended. While early release of clinical trial data to physicians and patients can inform enrollment decision making, it may also affect key operating characteristics of the trial, statistical validity and trial duration. We investigate the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options. We use simulation models of phase II glioblastoma (GBM) clinical trials in which early efficacy and toxicity estimates are periodically released accordingly to a pre-specified protocol. Patients can use the reported interim efficacy and toxicity information, with the support of physicians, to decide which trial to enroll in. We describe potential effects on various operating characteristics, including the study duration, selection bias and power.

Indexed as

Patient-Specific ModelingAntineoplastic AgentsBrain NeoplasmsClinical Trials as TopicDecision MakingDrugs, InvestigationalGlioblastomaHumansInformation DisseminationPatient SafetyPatient SelectionSurvival AnalysisTime FactorsTreatment OutcomeAntineoplastic AgentsDrugs, Investigational

Identifiers

PMID33547324
PMCPMC7864990

What OpenQuestion holds

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LicenceCC BY
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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.