Clinical Trials Registration and Results Reporting and the Right to Health
Bibliographic record
Abstract
This chapter argues that access to information about clinical trials and the safety and effectiveness of drugs and medical devices should be recognized as a fundamental component of the right to health. An international registry can be developed without violating existing international trade or intellectual property agreements. It describes the existence of confidentiality obligations under international trade agreements. With the adoption of the FDA Amendment Act (FDAA), one can presume that the United States considers that limited mandatory trial registration and results reporting are compatible with its trade secrecy obligations under Trade-Related Aspects of Intellectual Property Rights (TRIPS) plus agreements. The fundamental human right to health cannot be instrumental to the TRIPS obligations. It is noted that the civil society assists the development of further tools to promote the transparency and the reliability of medical research.
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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 | 0.018 | 0.031 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.002 | 0.012 |
| Scholarly communication | 0.010 | 0.009 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.021 | 0.014 |
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".