Evidence map›Paper›PMID 41395175›Full record

ArticleJournal of clinical and translational science2025

Accelerating start-up cycles in investigator-initiated multicenter clinical trials.

Shannon Hillery, Ryan Majkowski, Ying Wang, Bradley Barney, Lindsay Eyzaguirre, Andrew Mould, Nichol McBee, Esther Woo, Elizabeth Holthouse, Kenneth Wiley and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

14 authors.

Shannon HilleryDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0009-0009-1544-752X
Ryan MajkowskiDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Ying WangYale Center for Clinical Investigation, Yale University School of Medicine, New Haven, CT, USA.
Bradley BarneySchool of Medicine and Utah Data Coordinating Center, University of Utah, Salt Lake City, UT, USA.
Lindsay EyzaguirreDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Andrew MouldDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Nichol McBeeDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Esther WooDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Elizabeth HolthouseDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Kenneth WileyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Salina P WaddyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Daniel FordInstitute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-2549-2289
Daniel F HanleyDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-9536-4258
Karen LaneDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-7529-0714

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Operational roadblocks and organizational delays in multicenter clinical trials have been evident for decades, with the start-up cycle being especially notorious for setbacks. To address these challenges and improve multicenter clinical trial execution, we developed an accelerated start-up (ASU) management strategy - a structured site onboarding approach based on lean management principles. Methods: Three elements were integrated into the strategy: a standardized workflow, a dedicated site navigator (SN), and an electronic tracking system. We examined the range, central tendencies, and distribution of site activation times among differing combinations of these three elements. To determine how these combinations affected individual start-up milestones, we fit mixed models to compare percent achievement of predetermined milestone benchmarks and time to completion. Results: Thirteen consecutive trials ( Conclusion: This sample trial start-up data supports that sites can meet ambitious timelines, underscoring the strategy's potential to streamline workflows and improve site team performance.

Indexed as

clinical trial start-uplean workflow pathwaysMulticenter clinical trialsteam sciencetrial innovation network

Identifiers

PMID41395175
PMCPMC12695510

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.