Evidence map›Paper›PMID 37456265›Full record

ArticleJournal of clinical and translational science2023

A framework for assessing clinical trial site readiness.

John B Buse, Christopher P Austin, S Claiborne Johnston, Freda Lewis-Hall, Andrew N March, Carolyn K Shore, Pamela Tenaerts, Joni L Rutter

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.1field-weighted citation impact, top 6% 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.

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

10 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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  7. Scientia pro bono humani generis: Science for the benefit of humanity.Journal of clinical and translational science · 2024
    Article
  8. Site readiness practices for clinical trials - considerations for CTSA hubs.Journal of clinical and translational science · 2023
    Article
  9. Article
  10. 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

8 authors at 7 institutions in 2 countries.

John B BuseDepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-9723-3876
Christopher P AustinFlagship Pioneering, Cambridge, Massachusetts, USA.
S Claiborne JohnstonHarbor Health, Austin, TX, USA.
Freda Lewis-HallRetired from Pfizer Inc., USA.
Andrew N MarchNational Academies of Sciences, Engineering, and Medicine, Washington, District of Columbia, USA.ORCID https://orcid.org/0000-0002-8575-7314
Carolyn K ShoreNational Academies of Sciences, Engineering, and Medicine, Washington, District of Columbia, USA.
Pamela TenaertsMedable, Inc, USA.
Joni L RutterNational Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USA.
National Academies of Sciences, Engineering, and Medicine · USAlbemarle (United States) · USData Harbor (United States) · USFlagship Pioneering (United States) · USNational Institutes of Health · USPfizer (United States) · USUniversity of North Carolina at Chapel Hill · US

Funding

North Carolina Translational and Clinical Sciences Institute (NC TraCS)UM1TR004406 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI NICHOLAS J SHAHEEN · 2023 to 2026
$37.5M
Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI P Darrell Neufer · 2020 to 2026
$11.0M
NCATS NIH HHS UM1 TR004406NIDDK NIH HHS P30 DK124723
6 · The paper itself

Abstract

Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.

Indexed as

adoption and implementationClinical trial sitesevaluationquality improvementsite readiness practices

Identifiers

PMID37456265
PMCPMC10346039
OpenAlexW4382323036

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.