Evidence map›Paper›PMID 25638754›Full record

ArticleContemporary clinical trials2015

Comparison of statistical and operational properties of subject randomization procedures for large multicenter clinical trial treating medical emergencies.

Wenle Zhao, Yunming Mu, Darren Tayama, Sharon D Yeatts

Registry-linked trialOpen access · greenAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02072226 (A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 40% of its field
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.

NCT02072226 phase3terminatednot on this map

A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS)

TypeinterventionalSponsorGenentech, Inc.Ran2014 to 2017Enrolled313ConditionsStrokeArmsAlteplase, Alteplase Placebo, Aspirin, Aspirin Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Trial
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 at 2 institutions in 1 country.

Wenle ZhaoDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: zhaow@musc.edu.
Yunming MuGenentech Inc., San Francisco, CA, USA.
Darren TayamaGenentech Inc., San Francisco, CA, USA.
Sharon D YeattsDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
GenentechMedical University of South Carolina · US

Funding

Workshop to Identify Collaborative Project(s) for the NIH StrokeNet and the Japan NEtwork for Clinical Stroke Trials (NECST)U01NS087748 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Catherine R. Dillon, Jordan J. Elm · 2014 to 2026
$14.1M
Neurological Emergencies Treatment Trials Network Statistical and Data ManagementU01NS059041 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DURKALSKI, VALERIE L, PALESCH, YUKO Y · 2006 to 2015
$9.1M
The ALIAS StudyU01NS054630 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PALESCH, YUKO Y · 2005 to 2010
$6.9M
NINDS NIH HHS U01NS0059041NINDS NIH HHS U01 NS054630NINDS NIH HHS U01NS054630NINDS NIH HHS U01 NS059041NINDS NIH HHS U01 NS087748NINDS NIH HHS U01NS087748
6 · The paper itself

Abstract

Large multicenter acute stroke trials demand a randomization procedure with a high level of treatment allocation randomness, an effective control on overall and within-site imbalances, and a minimized time delay of study treatment caused by the randomization procedure. Driven by the randomization algorithm design of A Study of the Efficacy and Safety of Activase (Alteplase) in Patients with Mild Stroke (PRISMS) (NCT02072226), this paper compares operational and statistical properties of different randomization algorithms in local, central, and step-forward randomization settings. Results show that the step-forward randomization with block urn design provides better performances over others. If the concern on the potential time delay is not serious and a central randomization system is available, the minimization method with an imbalance control threshold and a biased coin probability could be a better choice.

Indexed as

EmergenciesRandom AllocationAlgorithmsAspirinComputer SimulationDouble-Blind MethodFibrinolytic AgentsHumansMulticenter Studies as TopicPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicStrokeTime-to-TreatmentTissue Plasminogen ActivatorAspirinFibrinolytic AgentsPlatelet Aggregation InhibitorsTissue Plasminogen ActivatorAcute stroke trialAllocation randomnessBaseline balanceStep-forward randomizationTreatment time delay

Identifiers

PMID25638754
PMCPMC4380760
OpenAlexW2057433642

What OpenQuestion holds

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Registered trials

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.