Evidence map›Paper›PMID 23851466›Full record

ArticleJournal of the American Medical Informatics Association : JAMIA2013

Design-phase prediction of potential cancer clinical trial accrual success using a research data mart.

Jack W London, Luanne Balestrucci, Devjani Chatterjee, Tingting Zhan

Abstract read
In one paragraph

Article in Journal of the American Medical Informatics Association : JAMIA, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. SMART-on-FHIR implemented over i2b2.Journal of the American Medical Informatics Association : JAMIA · 2017
    Article
  7. Article
  8. Electronic health records-driven phenotyping: challenges, recent advances, and perspectives.Journal of the American Medical Informatics Association : JAMIA · 2013
    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

4 authors.

Jack W LondonKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Luanne Balestrucci
Devjani Chatterjee
Tingting Zhan

Funding

X-Ray Crystallography and Macromolecular CharacterizationP30CA056036 · NCI · THOMAS JEFFERSON UNIVERSITY · PI Andrew Chapman · 1995 to 2026
$94.8M
NCI NIH HHS P30 CA056036NCI NIH HHS P30CA056036
6 · The paper itself

Abstract

backgroundMany cancer interventional clinical trials are not completed because the required number of eligible patients are not enrolled.

objectiveTo assess the value of using a research data mart (RDM) during the design of cancer clinical trials as a predictor of potential patient accrual, so that less trials fail to meet enrollment requirements. MATERIALS AND

methodsThe eligibility criteria for 90 interventional cancer trials were translated into i2b2 RDM queries and cohort sizes obtained for the 2 years prior to the trial initiation. These RDM cohort numbers were compared to the trial accrual requirements, generating predictions of accrual success. These predictions were then compared to the actual accrual performance to evaluate the ability of this methodology to predict the trials' likelihood of enrolling sufficient patients.

resultsOur methodology predicted successful accrual (specificity) with 0.969 (=31/32 trials) accuracy (95% CI 0.908 to 1) and predicted failed accrual (sensitivity) with 0.397 (=23/58 trials) accuracy (95% CI 0.271 to 0.522). The positive predictive value, or precision rate, is 0.958 (=23/24) (95% CI 0.878 to 1). DISCUSSION: A prediction of 'failed accrual' by this methodology is very reliable, whereas a prediction of accrual success is less so, as causes of accrual failure other than an insufficient eligible patient pool are not considered.

conclusionsThe application of this methodology to cancer clinical design would significantly improve cancer clinical research by reducing the costly efforts expended initiating trials that predictably will fail to meet accrual requirements.

Indexed as

Clinical Trials as TopicDatabases as TopicNeoplasmsPatient SelectionCohort StudiesHumansRegistriesRetrospective Studiesclinical trialsdata miningi2b2research data martssecondary research use of clinical data

Identifiers

PMID23851466
PMCPMC3861912

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.