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Enhancing global clinical trial transparency for better health outcomes for all 

2025· preprint· en· W4411668995 on OpenAlexaff
Wei Zhang, Nicholas DeVito, An‐Wen Chan, Christine Cunningham, Justin Pymento, Ghassan Karam, John Owuor, Vasee Moorthy

Bibliographic record

VenueF1000Research · 2025
Typepreprint
Languageen
FieldEconomics, Econometrics and Finance
TopicHealth Systems, Economic Evaluations, Quality of Life
Canadian institutionsWomen's College HospitalUniversity of Toronto
FundersEuropean and Developing Countries Clinical Trials PartnershipDepartment of Health and Social CareNational Institute for Health and Care ResearchGovernment of the United KingdomBill and Melinda Gates Foundation
KeywordsOpen peer reviewPlant biologyTransparency (behavior)Open dataMedicineOpen sciencePhysiologyClinical trialNeuroscienceIntensive care medicineBiologyInternal medicineComputer scienceMathematicsWorld Wide WebStatistics

Abstract

fetched live from OpenAlex

Background In 2022, WHO’s World Health Assembly adopted resolution WHA75.8, emphasizing the critical role of clinical trials in generating high-quality evidence and promoting equitable access to health interventions globally. In response, rapid landscape reviews were conducted to assess global clinical trial regulations, capacities, and funding distribution. Methods The analysis synthesized regulatory frameworks from 94 countries, institutional capacity data from the WHO International Clinical Trial Registry Platform (ICTRP), and funding data from World RePORT for trials registered between 2018-2022. Gaps in data availability and quality were assessed. Results Most countries reference international ethical guidelines, with universal requirements for ethics approval and informed consent. However, only 66% mandate public trial registration, and 40% require results reporting, with stark disparities between high- and low-income countries. High-income countries host over half of global trials; low-income countries contribute less than 1% despite high disease burden. Clinical trials sponsored by non-commercial entities are particularly scarce in low- and middle-income countries. Funding remains concentrated in the Americas and European regions, primarily driven by major funders such as the National Institutes of Health in the United States of America and European Commission. Significant data accessibility challenges persist due to incomplete registry records, inconsistent standards, lack of harmonized identifiers, and limited bulk data access. Recommendations Urgent actions include reinforcing international standards for trial registries, harmonizing data fields, improving registry interoperability, leveraging unique identifiers, enhancing multilingual accessibility, auditing data quality, pooling analytical resources, promoting open data policies, and investing in registry infrastructure and trained personnel. Conclusion Addressing data gaps and inequities in clinical trial ecosystems requires concerted action by global stakeholders. Improved data transparency and interoperability are essential to guide equitable research investments, foster coordination, and strengthen clinical trial capacity worldwide.

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 machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.658
metaresearch head score (Gemma)0.729
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Open science
Consensus categoriesMetaresearch
DomainCandidate signal: Reproducibility · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.995
Threshold uncertainty score0.422

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.6580.729
Meta-epidemiology (narrow)0.0010.002
Meta-epidemiology (broad)0.0020.006
Bibliometrics0.0080.009
Science and technology studies0.0030.012
Scholarly communication0.0270.023
Open science0.0050.024
Research integrity0.0080.019
Insufficient payload (model declined to judge)0.0220.005

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 head0.801
GPT teacher head0.651
Teacher spread0.150 · 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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designTheoretical or conceptual
DomainReproducibility
GenreCommentary

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
Published2025
Admission routes1
Has abstractyes

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