Evidence map›Paper›PMID 36617553›Full record

GuidelineBMC medicine2023

Recommendations for robust and reproducible preclinical research in personalised medicine.

Vibeke Fosse, Emanuela Oldoni, Florence Bietrix, Alfredo Budillon, Evangelos P Daskalopoulos, Maddalena Fratelli, Björn Gerlach, Peter M A Groenen, Sabine M Hölter, Julia M L Menon and 9 more

Abstract readPractice GuidelineReview
In one paragraph

Guideline in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing 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

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

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. [Biomarkers and Their Role in Understanding Osteoarthritis].Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca · 2025
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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.

Vibeke FosseDepartment of Clinical Science, Centre for Cancer Biomarkers, University of Bergen, Bergen, Norway. vibeke.fosse@uib.no.ORCID 0000-0001-9021-4843
Emanuela OldoniEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, The Netherlands.
Florence BietrixEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, The Netherlands.
Alfredo BudillonIstituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy.
Evangelos P DaskalopoulosEuropean Commission, Joint Research Centre (JRC), Ispra, Italy.
Maddalena FratelliDepartment of Biochemistry and Molecular Pharmacology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Björn GerlachPAASP GmbH, Guarantors of EQIPD e.V., Central Institute for Mental Health in Mannheim, Mannheim, Germany.
Peter M A GroenenIdorsia Pharmaceuticals Ltd., 4123, Allschwil, Switzerland.
Sabine M HölterHelmholtz Munich, Oberschleißheim, Germany.
Julia M L MenonPreclinicaltrials.eu, Netherlands Heart Institute, Utrecht, The Netherlands.
Ali MobasheriResearch Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, 90570, Oulu, Finland.
Nikki OsborneResponsible Research in Practice, Horsham, UK.
Merel Ritskes-HoitingaDepartment of Population Health Sciences, IRAS, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.
Bettina RyllMelanoma Patient Network Europe, Uppsala, Sweden.
Elmar SchmittGlobal Regulatory Oncology, Merck Healthcare KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany.
Anton UssiEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, The Netherlands.
Antonio L AndreuEATRIS ERIC, European Infrastructure for Translational Medicine, Amsterdam, The Netherlands.
Emmet McCormackDepartment of Clinical Science, Centre for Cancer Biomarkers, University of Bergen, Bergen, Norway.
PERMIT group

Funding

Horizon 2020 Framework Programme 874825
6 · The paper itself

Abstract

backgroundPersonalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine.

methodsThese recommendations have been developed following four main steps: (1) a scoping review of the literature with a gap analysis, (2) working sessions with a wide range of experts in the field, (3) a consensus workshop, and (4) preparation of the final set of recommendations.

resultsDespite the progress in developing innovative and complex preclinical model systems, to date there are fundamental deficits in translational methods that prevent the further development of personalised medicine. The literature review highlighted five main gaps, relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. We identified five points of focus for the recommendations, based on the consensus reached during the consultation meetings: (1) clinically relevant translational research, (2) robust model development, (3) transparency and education, (4) revised regulation, and (5) interaction with clinical research and patient engagement. Here, we present a set of 15 recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine.

conclusionsAppropriate preclinical models should be an integral contributor to interventional clinical trial success rates, and predictive translational models are a fundamental requirement to realise the dream of personalised medicine. The implementation of these guidelines is ambitious, and it is only through the active involvement of all relevant stakeholders in this field that we will be able to make an impact and effectuate a change which will facilitate improved translation of personalised medicine in the future.

Indexed as

Precision MedicineHumansPersonalised medicinePolicyPreclinical modelsRegulationTranslational methods

Identifiers

PMID36617553
PMCPMC9826728

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.