P2_131 Two International Multiregional Investigator Initiated Clinical Trials on Vasculitis: Collaboration with EUVAS, VCRC and Nationwide Vasculitis Study Groups of Japan
Bibliographic record
Abstract
Background: Currently two international multiregional clinical trials on vasculitis are ongoing through collaboration with EUVAS, VCRC and the Japanese study groups (AMED and MHLW Research Committee on Intractable Vasculitis). Methods: PEXIVAS is a multi-center, international, open label, factorial design, randomized control trial in severe ANCA-associated vasculitis (AAV) evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. RITAZAREM is an international, open-label, randomized controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing AAV. For conducting the international clinical trials, two types of agreement was necessary. One is collaboration agreement between the central sponsor, Japanese sponsor, and the lead Japanese site. The other is clinical trial agreement between the lead Japanese site and each participating site in Japan. Results: PEXIVAS trial recruited 704 patients from over 100 hundred centers around the world including 12 patients from 6 Japanese centers. RITAZAREM trial aims to recruit 190 patients from over 30 centers around the world including 7 Japanese centers.
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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 | 0.013 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.012 | 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".