Evidence map›Paper›PMID 33569250›Full record

Trial reportPeerJ2021

Clinical relevance assessment of animal preclinical research (RAA) tool: development and explanation.

Kurinchi S Gurusamy, David Moher, Marilena Loizidou, Irfan Ahmed, Marc T Avey, Carly C Barron, Brian Davidson, Miriam Dwek, Christian Gluud, Gavin Jell and 8 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PeerJ, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Article
  5. Review
  6. Review
  7. 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

18 authors.

Kurinchi S GurusamyResearch Department of Surgical Biotechnology, University College London, London, England, UK.ORCID 0000-0002-0313-9134
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada.ORCID 0000-0003-2434-4206
Marilena LoizidouResearch Department of Surgical Biotechnology, University College London, London, England, UK.ORCID 0000-0002-0900-9795
Irfan AhmedDepartment of Surgery, NHS Grampian, Aberdeen, Scotland, UK.
Marc T AveyCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada.ORCID 0000-0002-8696-3232
Carly C BarronCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada.
Brian DavidsonResearch Department of Surgical Biotechnology, University College London, London, England, UK.
Miriam DwekSchool of Life Sciences, University of Westminster, London, England, UK.ORCID 0000-0001-7184-2932
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copehagen, Denmark.ORCID 0000-0002-8861-0799
Gavin JellResearch Department of Surgical Biotechnology, University College London, London, England, UK.ORCID 0000-0001-8115-1609
Kiran KatakamCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copehagen, Denmark.
Joshua MontroyDepartment of Anesthesiology and Pain Medicine, Blueprint Translational Research Group, Clinical Epidemiology and Regenerative Medicine Programs, Ottawa Hospital Research Institute, Ottawa Hospital, Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, ON, Canada.
Timothy D McHughUCL Centre for Clinical Microbiology, Division of Infection & Immunity, University College London, London, England, UK.ORCID 0000-0003-4658-8594
Nicola J OsborneResponsible Research in Practice, London, England, UK.ORCID 0000-0001-9137-6596
Merel Ritskes-HoitingaSYRCLE, Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands.ORCID 0000-0001-5315-284X
Kees van LaarhovenDepartment of Surgery, Radboud Institute for Health Sciences, Nijmegen, Netherlands.
Jan VollertPain Research, Department of Surgery & Cancer, Imperial College, London, England, UK.
Manoj LaluDepartment of Anesthesiology and Pain Medicine, Blueprint Translational Research Group, Clinical Epidemiology and Regenerative Medicine Programs, Ottawa Hospital Research Institute, Ottawa Hospital, Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnly a small proportion of preclinical research (research performed in animal models prior to clinical trials in humans) translates into clinical benefit in humans. Possible reasons for the lack of translation of the results observed in preclinical research into human clinical benefit include the design, conduct, and reporting of preclinical studies. There is currently no formal domain-based assessment of the clinical relevance of preclinical research. To address this issue, we have developed a tool for the assessment of the clinical relevance of preclinical studies, with the intention of assessing the likelihood that therapeutic preclinical findings can be translated into improvement in the management of human diseases.

methodsWe searched the EQUATOR network for guidelines that describe the design, conduct, and reporting of preclinical research. We searched the references of these guidelines to identify further relevant publications and developed a set of domains and signalling questions. We then conducted a modified Delphi-consensus to refine and develop the tool. The Delphi panel members included specialists in evidence-based (preclinical) medicine specialists, methodologists, preclinical animal researchers, a veterinarian, and clinical researchers. A total of 20 Delphi-panel members completed the first round and 17 members from five countries completed all three rounds.

resultsThis tool has eight domains (construct validity, external validity, risk of bias, experimental design and data analysis plan, reproducibility and replicability of methods and results in the same model, research integrity, and research transparency) and a total of 28 signalling questions and provides a framework for researchers, journal editors, grant funders, and regulatory authorities to assess the potential clinical relevance of preclinical animal research.

conclusionWe have developed a tool to assess the clinical relevance of preclinical studies. This tool is currently being piloted.

Indexed as

Animal studiesClinical relevanceExperimental studiesPreclinical studies

Identifiers

PMID33569250
PMCPMC7847198

What OpenQuestion holds

Textmetadata
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.