β-Thalassemia · governance
Intended Use & Limitations
Version v1.0.0-rc3 · last updated 2026-08-15T09:14:00Z
Research preview · this page documents the demonstrator's intended use and explicit out-of-scope uses. Regulatory / QMS approval is performed off-platform.
Intended use
Research-preview decision-support for an MDT discussing curative therapy (HSCT or gene therapy) in transfusion-dependent β-thalassemia. NOT for clinical use, NOT an eligibility verdict.
Known limitations
- Discrimination is modest and, for some endpoints (graft-failure, cGvHD-d180), near chance on the held-out synthetic test split.
- Trial anchors are context for orientation, not the model's prediction for this patient.
- No prospective validation; no calibration against a real Thai β-thalassemia cohort.
- Confidence intervals are illustrative, not data-derived.
Out of scope
- Use as an eligibility verdict for HSCT, gene therapy, or any curative procedure.
- Non-transfusion-dependent thalassemia (NTDT), HbH disease, sickle/β-thal compound.
- Donor selection, conditioning intensity, or busulfan-dose individualisation decisions.
- Pediatric pre-transfusion management or iron-chelation regimen choice.
- Any use on real (non-synthetic) patient data without IRB approval and PDPA consent.
Contraindications to use of the tool
These are contraindications to USE OF THE TOOL — they are not contraindications to any underlying therapy.
- Do NOT use this tool to override an MDT or treating-physician decision.
- Do NOT use outputs in patient-facing communication or consent documents.
- Do NOT use in jurisdictions where the tool has not been reviewed by the local QMS / regulatory authority.
This interface presents outputs of a research-preview prediction model. It is not a regulated decision-support tool. Predictions come from one calibrated XGBoost classifier per endpoint, fitted on a synthetic-labeled cohort (no PHI; labels anchored to published base rates) and evaluated on a held-out synthetic test split. Not pre-registered; not externally validated.