Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process
Bibliographic record
Abstract
Background: Conducting clinical trials (CTs) with children presents several challenges. A major challenge is the need to enrol participants at multiple sites across different jurisdictions. Regardless of whether the trials involve children, adults, or both, CTs need to meet separate Competent Authority (CA) requirements to proceed in each participating country. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the regulatory requirements including any specific to pediatrics, as well as current or upcoming changes across six jurisdictions-the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia. Methods: An open questionnaire developed by the WG and directed at both the CA and the national pediatric clinical trial networks arranged by jurisdictions. Results: A synopsis of the current legislative and regulatory requirements for CTs applications, application submission processes and application requirements is presented for each of the six jurisdictions. Requirements were found to be mostly consistent across jurisdictions. No difference was found in processes for CTs submission, review, and authorization for pediatric CTs vs. CTs in adults. However, there are additional Ethics Committee/Institutional Review Board requirements for clinical trials including children. Some jurisdictions are considering adopting a risk-based approach, inspired by the Organization of Economic Co-operation and Development (OECD) recommendations on Governance. Changes currently or soon to be implemented in some jurisdictions are also described. Conclusions: Regulators from the jurisdictions represented in this WG are collaborating to facilitate regulatory harmonization and foster international alignment of pediatric CTs. By interacting with their respective regulatory bodies and developing expertise in their jurisdiction's regulatory requirements, national pediatric networks can support both academic and industry sponsors in navigating the regulatory process for CTs.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.415 | 0.458 |
| Meta-epidemiology (narrow) | 0.001 | 0.003 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.008 | 0.010 |
| Scholarly communication | 0.018 | 0.019 |
| Open science | 0.007 | 0.010 |
| Research integrity | 0.029 | 0.021 |
| Insufficient payload (model declined to judge) | 0.007 | 0.008 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".