Humanitarian Access to Unapproved Interventions in Public Health Emergencies of International Concern
Bibliographic record
Abstract
Points• Time-sensitive access to unapproved experimental interventions should be permitted on humanitarian grounds when patients or communities are facing death or irreversible disease progression and no other efficacious diagnostic, preventive, or therapeutic alternative exists.• Regulatory deficits could stymie time-sensitive efforts to contain public health threats when no efficacious curative, therapeutic, or preventive interventions exist to counter the threat in question.• United States regulatory mechanisms may provide useful guidance from a regulatory perspective to policy makers grappling with how to adequately prepare for, or respond to, potential or emerging public health emergencies.• Access to unapproved experimental interventions should be underpinned by a robust monitoring and evaluation component that will inform product development and licensure.
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 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 | 0.021 | 0.068 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.002 | 0.006 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.041 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".