Evidence map›Paper›PMID 33461595›Full record

ArticleTrials2021

Managing clinical trials during COVID-19: experience from a clinical research facility.

Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley, Joseph A Eustace

Abstract readLetter
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
–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

33 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Monitoring strategies for clinical intervention studies.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Lessons on Resilient Research: Adapting the Tribal Turning Point Study to COVID-19.American Indian and Alaska native mental health research (Online) · 2022
    Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Observational
  14. Resource management and capacity planning for clinical trial sites.Journal of clinical and translational research · 2024
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

9 authors.

Frances ShielyTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland. f.shiely@ucc.ie.ORCID http://orcid.org/0000-0003-0969-8321
Jean FoleyTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Amy StoneTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Emma CobbeTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Shaunagh BrowneTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Ellen MurphyTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Maeve KelseyTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Joanne Walsh-CrowleyTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
Joseph A EustaceTrials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

Indexed as

COVID-19Academies and InstitutesAdministrative PersonnelClinical Trials as TopicClinical Trials, Phase III as TopicCommunicable Disease ControlCommunicationData CollectionHospitals, UniversityHumansIrelandLeadershipPatient DropoutsPatient SelectionPersonnel Staffing and SchedulingPublic PolicyClinical trialsCOVID-19PandemicParticipant safetyTrial management

Identifiers

PMID33461595
PMCPMC7812560

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.