NMD-VCell Research Workbench Module: Validate / registry · evidence-to-experiment workflow NMD = neuromuscular disorders
v1.0 candidate Frozen 25 Jul 2026 DOI pending
v1.0.0-database-resource Schema 1.1 Model ridge-safe-v2.3 Benchmark repeated-fold-v2.2 Build EA-20260729-15 v1.0 is a database and evidence-governance release; it is not a validated disease-prediction or clinical decision-support release.
Current evidence ceiling L2 observed HepG2 limited L3a context No independent DMD perturbation validation Open boundary

Prediction readiness gate

Prediction is a separate scientific release, not a label upgrade.

No P1 or P2 prediction claim can be made until independent disease-relevant perturbation data, prospective registration, external test results, calibration, uncertainty, OOD and abstention analyses are frozen.

P0 is active; P1 and P2 remain locked.P0 prediction infrastructure ready P1 unvalidated P2 locked. Current release can expose P0 infrastructure and prospective registration scaffolds. It cannot claim P1 research-use DMD prediction or P2 clinical prediction.

P0/P1/P2 ladder

What is unlocked today?

P0 · Prediction infrastructure onlyPASSregistry, schema, benchmark and abstention infrastructure exist
P1 · Research-use DMD perturbation-response predictionLOCKED_PENDING_EXTERNAL_VALIDATIONnone in this release
P2 · Clinical disease prediction or decision supportLOCKED_NOT_IN_SCOPEnone

Current denominators

The registry is intentionally empty

Governed hypotheses21
Observed HepG2 perturbations21
External myoblast context screens9
Independent muscle/DMD perturbation replications0
Registered predictions0
Measured outcomes0

Zero registered predictions and zero measured outcomes mean no qualifying prediction/outcome object exists; this is not a negative validation result.

Allowed now

P0 infrastructure claims

  • static prediction-registration schema and empty registry are available
  • same-HepG2 perturbation-response benchmark is auditable
  • future prospective outcomes can be linked without overwriting predictions
  • evidence gaps and abstention requirements are explicit

Locked

Claims not authorized

  • validated DMD disease predictor
  • therapeutic response predictor
  • clinical decision-support platform
  • treatment-prioritization engine

P1 unlock package

Minimum evidence before research-use DMD prediction

P1 requires independent disease-relevant perturbation validation before any research-use DMD prediction claim can be unlocked.

P1 required before unlock

  • frozen DMD/dystrophin-deficient human myogenic or neuromuscular perturbation dataset
  • train/validation/external-test partition declared before model fitting
  • donor, isogenic-pair or perturbation unit of analysis declared
  • negative, positive and rescue/control definitions predeclared
  • primary functional endpoint and transcriptomic secondary endpoints frozen
  • baseline models, calibration, uncertainty intervals and abstention policy benchmarked
  • out-of-distribution detection and failure-mode taxonomy frozen
  • prospective prediction cards timestamped before outcome access
  • outcome board populated without relabelling failed or abstained predictions

P2 remains out of scope until

  • clinical intended-use statement
  • independent external clinical validation
  • decision-impact or workflow evaluation protocol
  • bias, safety, monitoring and human-oversight plan
  • regulatory and ethics review appropriate to intended use
Reporting alignment. TRIPOD+AI-style model reporting fields are required before a P1 prediction claim DECIDE-AI/SPIRIT-AI/CONSORT-AI-style clinical evaluation fields are not triggered until a clinical workflow is proposed