Module 4 · Reasoning Layer

Experimental Design Intelligence

A protocol scaffold generated for your active project — arms, controls, endpoints, statistics and a quality checklist.

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MODEL: In-vivoIn-vitroOrganoidClinicalNAM
1
Objective
2
Design
3
Endpoints
4
Stats
5
Checklist

Study design

ArmTreatmentn

Endpoints & biomarkers

Primary
◆
Disease-relevant efficacy endpoint
Quantitative primary outcome.
◆
Histopathology / grading
Structural readout.
Mechanistic biomarkers

Statistical plan

Test

One-way ANOVA + Tukey HSD; Kaplan–Meier for time-to-event.

Power

80% power, α=0.05 → n per arm from effect size.

Synergy

Chou-Talalay CI for combination arms.

Quality checklist

✓
Randomisation
Block-randomised allocation.
✓
Blinding
Blinded outcome scoring.
✓
Sample size justified
Power calc documented.
!
Reporting standard
ARRIVE / CONSORT fields pending.
!
Ethics approval
IEC/IAEC submission required.

Economics (heuristic)

Risk factors

Bioavailability / delivery — optimise formulation early.
Translation — model-to-human extrapolation limited.