L’accès à l’information et le droit à la santé : La transparence des essais cliniques comme une obligation dans le contexte des droits de l’Homme (Access to Information and the Right to Health: Transparency of Clinical Trials as a Human Rights Obligation)
Bibliographic record
Abstract
This chapter is a short version in French of an article published in the American Journal of Law and Medicine (http://ssrn.com/abstract=1932436). The chapter discusses why access to information related to clinical drug trials can be qualified as a fundamental component of the right to health. This approach rejoins the claim of authors who characterize clinical drug trials as public goods. Yet, it offers also a legal and moral basis for the immediate implementation of transparency measures, regardless of more fundamental reform of drug regulation. Framing access to clinical trials data as a component of the right to health offers strong support against the argument that transparency measures may violate international trade obligations related to data secrecy and provides a basis for claiming that states have a duty to implement such measures. The paper first provides a detailed overview of the historical development of clinical trials and results reporting registries. It then analyzes the arguments invoked against mandatory trial registration and results reporting, zooming in on claims based on data secrecy obligations under TRIPS and TRIPS Plus agreements. The paper explores why registries can generally be justified under public interest exceptions in international trade agreements and how the existence of data exclusivity regimes already provides protection against ‘unfair commercial use’ of clinical trials data. In the final section of the paper, the implementation of clinical trial and results reporting registries is situated in the context of the right to health. This not only promotes individual empowerment in requesting access to relevant health information, but also suggests that states have a duty to develop reliable and publicly accountable information systems. Such systems should enable independent medical research groups and civil society in general to contribute meaningfully to publicly accountable medical research and health product development.
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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 | 0.022 | 0.034 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.006 | 0.031 |
| Scholarly communication | 0.027 | 0.023 |
| Open science | 0.002 | 0.009 |
| Research integrity | 0.017 | 0.018 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
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".