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Record W4408936178 · doi:10.1016/s2214-109x(24)00511-4

Strengthening the paediatric clinical trial ecosystem to better inform policy and programmes

2025· review· en· W4408936178 on OpenAlexaff
James A. Berkley, Judd L. Walson, Glenda Gray, Fiona M. Russell, Zulfiqar A Bhutta, Per Ashorn, Shane A. Norris, Ebunoluwa A. Adejuyigbe, Rebecca F. Grais, Bernhards Ogutu, Jun Zhang, Guillermo Chantada, Sharon Nachman, Edward Kija, Fyezah Jehan, Carlo Giaquinto, Nigel Rollins, Martina Penazzato

Bibliographic record

VenueThe Lancet Global Health · 2025
Typereview
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsCentre for Global Health Research
FundersEuropean and Developing Countries Clinical Trials PartnershipEgerton UniversityGovernment of the United KingdomDepartment of Health and Social CareWorld Health OrganizationNational Institute for Health and Care ResearchBill and Melinda Gates Foundation
KeywordsEcosystemMEDLINEEnvironmental planningEnvironmental resource managementMedicineEconomic growthPolitical scienceGeographyEnvironmental scienceEcologyEconomicsBiology

Abstract

fetched live from OpenAlex

The first WHO Global Clinical Trials Forum was convened in November, 2023 to develop a shared vision of an effective global clinical trial infrastructure. The Paediatric Clinical Trials Working Group was formed to provide perspectives, identify challenges, and propose solutions to strengthen the paediatric clinical trials ecosystem. Participants represented paediatric disciplines, including infectious diseases, nutrition, neonatology, pharmacology, oncology, neurodevelopment, public health, and policy. Childhood diseases have profound lifelong effects on health, livelihoods, and societies. Investment in early childhood results in highly cost-effective changes to lifelong health, productivity, and human capital returns. Yet, there remain substantial gaps in knowledge on the efficacy and safety of many paediatric interventions, which represents a failure to establish shared priorities and alignment across governments, researchers, communities, and funders. Children are frequently marginalised from clinical trials, which is an issue of equity. Challenges include mismatched priorities and funding, risk adversity, poor design, power imbalances, and inadequate infrastructure. Solutions include aligning on and tracking local and global child health priorities against funding and supporting regional consortia to pool resources for larger, more consequential trials. We propose actions and responsibilities for global, regional, and national institutions for prioritisation, coordination, enabling paediatric trials consortia, funding, and tracking progress.

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)0.004
metaresearch head score (Gemma)0.002
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: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.971
Threshold uncertainty score0.534

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

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 head0.245
GPT teacher head0.576
Teacher spread0.331 · 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
GenreReview

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

Citations10
Published2025
Admission routes1
Has abstractyes

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