Evidence map›Paper›PMID 38821259›Full record

ArticleContemporary clinical trials2024

Selecting trial centers using a standardized, automated site assessment survey instrument (SASI).

Karen Lane, Shannon Hillery, Ryan Majkowski, Bradley J Barney, Daniel Amirault, Sarah J Nelson, Mary Bailey, Eun Hea Unsicker, Mary Stroud, Lindsay M Eyzaguirre and 10 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Insights from the trial innovation network's initial consultation process.Journal of clinical and translational science · 2025
    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

20 authors.

Karen LaneDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: klane@jhmi.edu.
Shannon HilleryDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: shiller1@jhmi.edu.
Ryan MajkowskiDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: rmajkow1@jhmi.edu.
Bradley J BarneyDepartment of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: bradley.barney@hsc.utah.edu.
Daniel AmiraultDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: amirault@vrtx.com.
Sarah J NelsonVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Electronic address: sarah.j.nelson@vumc.org.
Mary BaileyDuke Clinical Research Institute, Durham, NC, USA. Electronic address: mary.bailey@duke.edu.
Eun Hea UnsickerDepartment of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: EunHea.Unsicker@hsc.utah.edu.
Mary StroudVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Electronic address: mary.stroud@vumc.org.
Lindsay M EyzaguirreDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: LEyzaguirre@jhu.edu.
Amy GawadDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: agawad1@jhu.edu.
Angeline NanniDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: ananni2@jhu.edu.
Gwendolyn MirzoyanWake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: gmirzoya@wakehealth.edu.
Theodora CohenTufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Salina P WaddyNational Center for Advancing Translational Sciences, Bethesda, MD, USA. Electronic address: salina.waddy@nih.gov.
Ken WileyNational Center for Advancing Translational Sciences, Bethesda, MD, USA. Electronic address: ken.wiley@nih.gov.
Paul A HarrisVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: paul.a.harris@vumc.org.
Daniel E FordDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dford@jhmi.edu.
Daniel HanleyDepartment of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dhanley@jhmi.edu.
Trial Innovation Network

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2016 to 2022
$177.0M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
Expediting the Sharing of APS Consortium Specimens and Data Amidst Expanded OperationsU01HL168478 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Christopher J. Lindsell, Wesley H Self · 2023 to 2026
$23.0M
Catalyzing and Harmonizing Operational Innovation for Recruitment (CHOIR)U24TR004432 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, CONSUELO HOPKINS WILKINS · 2023 to 2026
$20.9M
Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC)U24TR004437 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Gordon Raphael Bernard, Jonathan Dale Casey · 2023 to 2026
$19.9M
Johns Hopkins University Trial Innovation CenterU24TR004440 · NCATS · JOHNS HOPKINS UNIVERSITY · PI DANIEL F HANLEY · 2023 to 2026
$19.6M
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001608NCATS NIH HHS U24 TR001609NCATS NIH HHS U24 TR004432NCATS NIH HHS U24 TR004437NCATS NIH HHS U24 TR004440NHLBI NIH HHS U01 HL168478
6 · The paper itself

Abstract

backgroundTo improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.

aimAs a first step, we wanted to confirm that an expanded survey could be feasible and generalizable-that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.

methodsA standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.

resultsRespondents thought the SASI collected useful and relevant information about their sites (100%). Sites were "comfortable" (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.

conclusionsCoordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.

Indexed as

Clinical Trials as TopicHumansMulticenter Studies as TopicSurveys and QuestionnairesClinical trialsFeasibility surveyQuality improvementSite performance metricsSite selectionTrial management

Identifiers

PMID38821259
PMCPMC11283960

What OpenQuestion holds

Textmetadata
LicenceTDM
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.