Evidence map›Paper›PMID 23503303›Full record

ArticleStatistical methods in medical research2016

Simulating the contribution of a biospecimen and clinical data repository in a phase II clinical trial: A value of information analysis.

Benjamin M Craig, Gang Han, Murat K Munkin, David Fenstermacher

Abstract read
In one paragraph

Article in Statistical methods in medical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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.

Benjamin M CraigHealth Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA Department of Economics, University of South Florida, Tampa, FL, USA Benjamin.craig@moffitt.org.
Gang HanProgram of Applied Translational Research, Department of Internal Medicine, Yale University School of Medicine, USA.
Murat K MunkinDepartment of Economics, University of South Florida, Tampa, FL, USA.
David FenstermacherHealth Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA Department of Biomedical Informatics, Moffitt Cancer Center, Tampa, FL, USA.

Funding

Developing Information Infrastructure Focused on Cancer Comparative EffectivenessRC2CA148332 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI FENSTERMACHER, DAVID ALAN · 2009 to 2009
$2.0M
Developing Information Infrastructure Focused on Cancer Comparative EffectivenessUC2CA148332 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI FENSTERMACHER, DAVID ALAN · 2010 to 2010
$2.0M
Obesity, Aging, and Cancer Cost (OACC) StudyK25CA122176 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI CRAIG, BENJAMIN M. · 2006 to 2010
$746k
NCI NIH HHS K25 CA122176NCI NIH HHS RC2 CA148332NCI NIH HHS UC2 CA148332
6 · The paper itself

Abstract

The potential contributions of a centralized data warehouse or repository in clinical research include the expedited accrual of subjects for phase II trials. Understanding the contribution of data warehouses that integrate clinical, biospecimen, and molecular data for the conduct of clinical trials is essential to inform private and public decisions on resource allocation and investment. We conducted a value of information analysis using data from recent trials at the Moffitt Cancer Center and simulated the potential reductions in trial size due to possible alternative scenarios of expedited accrual. In this study, we compared alternative data sets using a single model to assess value of information. Our findings suggest that the reductions in trial size range from 0% to 43%, depending on the amount of censoring in overall survival. The ability to expedite the accrual of patients for clinical trial studies using large data repositories that store data on inclusion/exclusion criteria and response to standard of care therapies demonstrated significant improvement in reducing the number of subjects needed to achieve similar end-results, as evaluated using value of information analysis with a limited number of parameters and a parsimonious model of overall survival.

Indexed as

Clinical Trials, Phase II as TopicHumansNeoplasmsResearch DesignSurvival Analysisbiorepositoryclinical trialsneoplasmsphase IIvalue of information

Identifiers

PMID23503303
PMCPMC3752320

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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.