Evidence map›Paper›PMID 41040632›Full record

ArticleJournal of clinical and translational science2025

Operationalizing a complex acute clinical trial: Lessons from the BEACH study.

Gracey Sorensen, Will Remillard, Maia Schlechter, Michael Kampp, Cailin Whisler Brady, Kaley Kildahl, Andrew Mould, Wendy Ziai, Karen Lane, Linda J Van Eldik and 5 more

Registry-linked trialAbstract readCase Reports
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. It is linked to trial NCT05020535 (Biomarker and Edema Attenuation in IntraCerebral Hemorrhage), 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
–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.

NCT05020535 phase2active not recruitingnot on this map

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial

TypeinterventionalSponsorJohns Hopkins UniversityRan2022 to 2027Enrolled120ConditionsIntracerebral HemorrhageArmsMW189, Saline
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Gracey SorensenDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.ORCID https://orcid.org/0009-0006-6805-5536
Will RemillardDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.
Maia SchlechterDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.
Michael KamppDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.
Cailin Whisler BradyBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Kaley KildahlBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Andrew MouldBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Wendy ZiaiBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0003-4548-7353
Karen LaneBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-7529-0714
Linda J Van EldikSanders-Brown Center on Aging and Department of Neuroscience, University of Kentucky, Lexington, KY, USA.ORCID https://orcid.org/0000-0002-8139-6400
Ashley DistasioYale New Haven Hospital, New Haven, CT, USA.
Jing LuInvestigational Drug Service, Yale New Haven Hospital, New Haven, CT, USA.
Lauren H SansingDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.ORCID https://orcid.org/0000-0002-6898-1680
Daniel F HanleyBIOS Clinical Trials Coordinating Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-9536-4258
Jessica Magid-BernsteinDepartment of Neurology, Yale School of Medicine, New Haven, CT, USA.ORCID https://orcid.org/0000-0001-6506-6017

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This report outlines the workflow, challenges, and key roles involved in operationalizing a complex, disruptive, acute clinical trial protocol requiring multidisciplinary collaboration. Yale University School of Medicine and the Neuroscience Intensive Care Unit (NICU) at Yale New Haven Hospital (YNHH) leverage interdisciplinary collaboration to successfully enroll patients into complex clinical trials, including the Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) trial (ClinicalTrials.gov identifier: NCT05020535). Successful execution of the BEACH trial relies on five key domains: ensuring patient safety, optimizing screening and enrollment, acquiring pharmacokinetics, identifying signals of efficacy, and adapting to operational challenges. These domains require precise coordination, communication, and adaptability within dynamic patient care environments. By streamlining workflows, all members of the care delivery team and the research team maximize efficiency and optimize patient enrollment while upholding the highest standards of ethical research and patient care. Implementation of the BEACH trial at the Yale research center exemplifies the critical role of interdisciplinary collaboration in clinical research. By integrating research into patient care, the team improves trial efficiency and contributes to innovative treatment strategies for intracerebral hemorrhage. Lessons learned can inform best practices for future acute trials and improve patient outcomes.

Indexed as

clinical trialhemorrhagic strokeinflammationIntracerebral hemorrhagetrial operations

Identifiers

PMID41040632
PMCPMC12485565

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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.