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Record W3167275474 · doi:10.1038/s41390-021-01587-3

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

2021· article· en· W3167275474 on OpenAlexaff
Athimalaipet V Ramanan, Neena Modi, Saskia N. de Wildt, Beate Aurich, Sophia Bakhtadze, Francisco Bautista, Fernando Cabañas, Lisa Campbell, Philippa A. Charlton, Wallace Crandall, Irmgard Eichler, Laura Fregonese, Daniel B. Hawcutt, Pablo Iveli, Thomas Jaki, Bosanka Jocić-Jakubi, Mats Johnson, Bülent Karadağ, Lauren E. Kelly, Ming Yann Lim, Carmen Moreno, Eva Neumann, Cécile Ollivier, Mehdi Oualha, Genny Raffaeli, Maria Alexandra Ribeiro, Emmanuel Roilides, Teresa de Rojas, Alba Rubio‐San‐Simón, Nicolino Ruperto, Maurizio Scarpa, Matthias Schwab, Angeliki Siapkara, Yogen Singh, Anne Smits, Pasquale Striano, Silvana Anna Maria Urru, Marina Vivarelli, Zorica Zivkoviz

Bibliographic record

VenuePediatric Research · 2021
Typearticle
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsUniversity of ManitobaChildren's Hospital Research Institute of Manitoba
FundersEMD SeronoIdorsia PharmaceuticalsNeuraxpharmH. Lundbeck A/SBayerServierEisaiSwedish Orphan BiovitrumAgenzia Italiana del Farmaco, Ministero della SaluteAlexion PharmaceuticalsApellis PharmaceuticalsInnovative Medicines InitiativeSanofiGW PharmaceuticalsAblynxMinistero dell’Istruzione, dell’Università e della RicercaEuropean Federation of Pharmaceutical Industries and AssociationsEuropean CommissionCelgenePfizerBiogenGlaxoSmithKlineAmgenMinistero della SaluteCSL BehringAstraZenecaEli Lilly and CompanyBristol-Myers Squibb
KeywordsPandemicCoronavirus disease 2019 (COVID-19)Equity (law)MedicineClinical trialHealth careMedical educationSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)BusinessPublic relationsPolitical sciencePathology

Abstract

fetched live from OpenAlex

BACKGROUND: The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org ) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. METHODS: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. FINDINGS: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent-patient-public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.015
metaresearch head score (Gemma)0.041
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Science and technology studies, Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.413
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0150.041
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.002
Science and technology studies0.0020.000
Scholarly communication0.0000.000
Open science0.0000.001
Research integrity0.0000.005
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.354
GPT teacher head0.561
Teacher spread0.207 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designNot applicable
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations12
Published2021
Admission routes1
Has abstractyes

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