The Patient's Voice: Patient Involvement in Medical Product Regulation
Bibliographic record
Abstract
Authorities responsible for regulating medicines and other medical products continue to expand opportunities for direct participation of patients and their representatives in regulatory processes. For example, patient representatives can participate as members of scientific committees and provide input in various ways. This article examines the current framework and recent initiatives for such participation in the US Food and Drug Administration and European Medicines Agency. It draws from scholarship on public and patient participation in other contexts to describe and clarify the purposes and roles of patient involvement and to identify issues needing attention in the development of these initiatives, including systemic factors that may impede the ability of patient representatives to fulfill their roles effectively. It also considers convergent efforts to engage patients in research and development that could alleviate some of these difficulties and provide an opportunity to rethink the goals and methods of patient involvement in a larger context.
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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 | 0.040 | 0.058 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.013 | 0.018 |
| Scholarly communication | 0.011 | 0.009 |
| Open science | 0.002 | 0.016 |
| Research integrity | 0.010 | 0.013 |
| Insufficient payload (model declined to judge) | 0.005 | 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".