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Record W4401235981 · doi:10.1136/bmjpo-2024-esdppp.29

29 Five-year report on the activities of the Connect4Children (c4c) European paediatric clinical trials network in Belgium

2024· article· en· W4401235981 on OpenAlexaboutno aff
Eva Degraeuwe, Laura Persyn, M. Turner, Lieve Nuytinck, Annelies De Maré, Daphné Christiaens, Ann Raes, Karel Allegaert, Johan Vande Walle

Bibliographic record

Venuenot available
Typearticle
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsnot available
Fundersnot available
KeywordsClinical trialStandardizationMedicineFamily medicineMedical educationBusinessPolitical science

Abstract

fetched live from OpenAlex

<h3>Background/Aims</h3> Currently, over 60% of clinical trials in children are unsuccessful due to insufficient recruitment, administrative burden, inadequate methodology, among other reasons. Sponsors experience difficulties identifying adequate and developed sites to conduct pediatric trials. To optimize and facilitate clinical trials, (inter)national networks have been developed by (academic) investigators such as the I-ACT for Children network (U.S.A.), Innovative Medicines Initiative 2 conect4children (IMI-c4c) grouped network (Europe), and MICRYN (Canada). For Belgium, the Paediatric Clinical Trial Network within BPCRN Belgian Paediatric Clinical Research Network), was developed in 2009 and included in c4c in 2018, managed by the Ghent University (Hospital). <h3>Method</h3> This report describes an update on the progress of c4c over the past 5 years. The Belgian Paediatric Clinical Trial Network has 15 hospitals connected. The network has been involved in 2 academic trials, 10 industry trials and over 35 preliminary feasibility requests. <h3>Results</h3> The Belgium national network (BPCRN) was selected in 2/4 academic trials, and 5/5 industry trials within c4c. Constructive communication with the sponsor increased the number of sites from 2 to 8 for the academic studies. The added value of the BPCRN in the academic trials was help by the national hub in regulatory submission and budget plan. For the industry studies, the administrative requests have been centrally buffered, with over 66% of the feasibility questionnaires being pre-filled. Moreover, an additional 32% new sites were identified for the industry sponsors. The network is also involved in i) data standardization, inclusion of real-world data and rare disease data-dictionary development, ii) expert panels and iii) teaching pan-European courses for site and investigator development. Moreover, the Belgian network has been the liaison for the totality of European national networks with the US-based network I-ACT for Children, for clinical trials running outside of the c4c project scope. <h3>Conclusion</h3> Over the past 5 years, substantial developments and progress have been made with the Belgium network activity by BPCRN. Central optimalisation of site identification, site development and trial start-up have been prioritized. To achieve a sustainable network after IMI2 funding, a longitudinal commitment of both sites and sponsors is needed.

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)0.012
metaresearch head score (Gemma)0.006
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
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 score0.363
Threshold uncertainty score0.755

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0120.006
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
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 head0.210
GPT teacher head0.466
Teacher spread0.256 · 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.

The models applied no category: nothing in the taxonomy fit this work.
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".

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Citations0
Published2024
Admission routes1
Has abstractyes

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