Evidence map›Paper›PMID 39105082›Full record

ArticleContemporary clinical trials communications2024

Redefining feasibility in clinical trials: Collaborative approaches for improved site selection.

Beau Bruneau, Kristin Surdam, Amy Bland, Amy Krueger, Andrew Wise, Ani Cotarlan, Asher Leviton, Elena Jouravleva, Grace Fitzgerald, Heather N Frost and 9 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Re-envisioning clinical trial design in systemic sclerosis.Expert review of clinical immunology · 2025
    Review
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

19 authors.

Beau BruneauFlorence Healthcare, USA.
Kristin SurdamKOL & Strategy, Florence Healthcare, USA.
Amy BlandClinical Research, Baptist Health Little Rock, USA.
Amy KruegerBon Secours Mercy Health, USA.
Andrew WiseElevation GCP Consulting, LLC, USA.
Ani CotarlanIcahn School of Medicine at Mount Sinai, USA.
Asher LevitonIcahn School of Medicine at Mount Sinai, USA.
Elena JouravlevaCorporate Quality and Education, Sarah Cannon Research Institute, USA.
Grace FitzgeraldSite Enablement League, USA.
Heather N FrostGlobal Clinical Information Solutions, Information Management, Pfizer Research & Development, Pfizer, USA.
Honora F CutlerClinical Research Operations, Drexel University, USA.
Joshua BuddleClinical Operations, Flatiron Health, USA.
Luis G DiazRegulatory, University of South Florida and Tampa General Hospital, USA.
Michele CohenIcahn School of Medicine at Mount Sinai, USA.
Nancy A SaccoClinical and Site Development Ops, SiteBridge Research, Inc, USA.
Ryan WashingtonCancer Clinical Trials Office, SUNY Stony Brook Cancer Center, USA.
Susan MauermannMedical College of Wisconsin, USA.
Victor ChenClinical Trials Program, The Permanente Medical Group, USA.
Andrea BastekInnovations, Florence Healthcare, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites. Methods: The task force was composed of representatives from sponsors, CROs and sites (43 % Sites, 20 % Site Networks, 10 % Small/mid-size sponsors, 10 % Small/mid-size CROs, 10 % Large sponsors, 7 % Large CROs). The group collaborated to define the scope of the problem, identify challenges in the current process, and provide suggestions for improving the process. Results: The group found there is a need for better differentiation between the three main stages of feasibility, and the four sub-phases of Site Feasibility. The discussion brought to light emerging trends like early initiation of Site Feasibility and premature engagement of sites by CROs. To fully explain these challenges, the group analyzed the current practices and documented their downstream impact on clinical trial execution for all stakeholders. A list of best practices emerged naturally from this analysis. These findings are aggregated into short and actionable best practice guides. Conclusion: The task force suggests practical changes for the feasibility process and raises awareness of emerging trends and their associated risks. This awareness can begin to drive change in the site feasibility process, although industry-wide transformation will require new levels of collaboration, data standardization and automation tools. The potential benefits of evolving this process are significant and meaningful for more efficient and successful clinical trials.

Indexed as

Clinical trial feasibilityClinical trial operationsSite feasibility

Identifiers

PMID39105082
PMCPMC11298845

What OpenQuestion holds

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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.