Evidence map›Paper›PMID 41204694›Full record

ArticleMuscle & nerve2026

Amyotrophic Lateral Sclerosis Clinical Research Site Operations: Emerging Challenges and Potential Solutions From Multiple Sites in the US.

Erica Scirocco, Sarah D Luppino, Matti D Allen, Elisa Giacomelli, Dario Gelevski, Max Higgins, Jennifer L Scalia, Alexandra C McCaffrey, Danica L Sanders, Doreen T Ho and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Muscle & nerve, 2026. 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.

Erica SciroccoDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0009-0002-9427-1452
Sarah D LuppinoDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Matti D AllenOttawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID https://orcid.org/0000-0002-0755-3164
Elisa GiacomelliDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Dario GelevskiDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-8287-5331
Max HigginsDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Jennifer L ScaliaDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Alexandra C McCaffreyDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Danica L SandersDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Doreen T HoDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Brandy QuarlesDepartment of Neurology and Neurosurgery, Augusta University, Augusta, Georgia, USA.
Honora DalamagasHospital for Special Care, New Britain, Connecticut, USA.
Sarah HeintzmanDivision of Neuromuscular Disorders, Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Sabrina PaganoniDepartment of Neurology, Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-0505-1168

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As the amyotrophic lateral sclerosis (ALS) clinical trial landscape continues to grow and evolve, optimization of research site efficiency is essential. Herein, we outline results from a formal discussion among multiple ALS research sites in the US to help establish and maintain efficient research site infrastructure. Ten ALS site managers collaborated over a 6-month period to develop a framework of operational strategies to support ALS clinical research sites. To address the evolving ALS research landscape, it was agreed that the traditional site operational model requires continuous evaluation and adaptation. Challenges, particularly affecting staff recruitment and retention (such as salary, burnout, and limited opportunities for professional growth for certain positions), were discussed. The group identified challenges related to increased burden to maintain staff training, evolving outcome measures, and limitations in available space. Sites agreed on the importance of well-trained and experienced site personnel, and the emergence of site research nurses and nurse practitioners as trial leaders. Successful strategies to address staffing barriers were discussed, recognizing the need for ongoing improvements and increased funding to support the research team. A centralized organizational approach, consisting of multiple specialized study teams supported by an overarching site operations infrastructure, was identified as a key driver to optimize staff performance, accelerate trial conduct, and streamline workflow. Future initiatives should include refining strategies to continuously enhance site operations, identify key metrics to quantify efficiency and ensure financial sustainability.

Indexed as

Amyotrophic Lateral SclerosisBiomedical ResearchClinical Trials as TopicHumansResearch PersonnelUnited Statesamyotrophic lateral sclerosiscentralized modelclinical trialsresearch careresearch site operations

Identifiers

PMID41204694
PMCPMC12690000

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.