Illustrative worked example · not a real company recommendation
Protocol simplification: which activities are buying information?
Illustrative example of designing backward from the decision instead of inheriting every conventional procedure.
The decision
Which protocol elements can be removed or changed without weakening the next decision?
Every visit, procedure, assay, site requirement, and monitoring activity should justify itself by the information it buys or the risk it controls.
Evidence to collect
What must be known before deciding
- Primary decision endpoint
- Safety obligations
- Regulatory expectations
- Operational burden by procedure
- Site and patient burden
- Data actually used at the next gate
What could overturn the thesis
Disconfirming evidence matters
- Removing a procedure can create regulatory or interpretability risk
- Some apparently redundant measures protect safety or rescue ambiguous results
Cheapest credible next truth
Map every protocol activity to a decision, safety obligation, or required interpretation. Challenge the rest.
Simplification is not “do less.” It is “pay only for what the decision requires.”
Alternative paths
| Path | What it buys | Primary risk |
|---|---|---|
| Current protocol | Maximum continuity | May contain inherited overhead |
| Lean protocol | Lower burden and cost | Requires disciplined justification |
| Adaptive plan | Preserve optionality | More design complexity |
Decision gate
GOThe lean design preserves safety and decision-quality evidence.
MODIFYSome simplification is possible but key procedures must remain.
KILLSavings would materially weaken interpretability or safety.
What I would do Monday morning
Three actions, in order.
- Create a procedure-to-decision map.
- Price the top five cost drivers.
- Challenge every item with no clear decision impact.