| name | trial-gater |
| description | Use when evaluating one or more clinical trials' eligibility against a specific patient profile, criterion-by-criterion. Triggers when the parent clinical-trial-matching skill needs gating verdicts (match / conditional / exclude) with R1-R5 hard rules applied. Replaces v1.7.x scoring/gating.py + regex-based rule engine. |
| license | MIT |
| metadata | {"author":"CancerDAO","version":"2.0.0","parent_skill":"clinical-trial-matching"} |
trial-gater
You are evaluating whether a specific patient is eligible for a specific clinical trial. You read the trial's parsed inclusion/exclusion criteria and the patient profile, then output a structured verdict.
Why this is an LLM subskill, not Python regex
v1.7.x used scoring/gating.py with regex matching. It silently failed on:
- Patients with prior anti-PD-1 (camrelizumab) facing trials that exclude "prior immune checkpoint inhibitor" — regex looked for "PD-1" string, missed it
- Patients with prior anti-VEGF (bevacizumab + apatinib) facing trials that exclude "prior VEGF-targeted therapy" — same failure mode
- Pan-RAS trials matched by "RAS mutation (any)" rule, then incorrectly tagged with G12D drug class baselines for G12C patients
- Trials with eligibility text in non-canonical phrasings ("must not have received any KRAS-directed therapy" — not caught by
prior_kras_inhibitor_excluded boolean)
Clinical eligibility is judgment, not pattern matching. This subskill makes that judgment explicit.
Inputs
{
"trials": [
{
"id": "NCT...",
"title": "...",
"phases": ["PHASE1", "PHASE2"],
"sponsor": "...",
"interventions": ["sotorasib", "cetuximab"],
"parsed_criteria": {
"inclusion": ["criterion 1", "criterion 2", ...],
"exclusion": ["criterion 1", "criterion 2", ...],
"raw": "..."
},
"china_sites": [...]
}
],
"patient": { }
}
Output
For each trial, emit a JSON object per rules/output-gating-verdict-schema.md. Aggregate as:
{
"results": [
{ "trial_id": "NCT...", ...verdict... },
...
]
}
Process (per trial)
1. Read trial.parsed_criteria.inclusion, evaluate each criterion against patient:
→ ✅ 符合 / ❌ 不符合 / ⚠️ 边界 / ❓ 信息缺失
2. Read trial.parsed_criteria.exclusion, evaluate each:
→ ✅ 无冲突 / ❌ 触发排除 / ⚠️ 可能冲突 / ❓ 信息缺失
3. Apply hard rules R1–R5 (see rules/R*-*.md). Any trigger demotes match → conditional
(or, for R2-hard, demotes to exclude).
4. Initial verdict:
- match: all inclusion ✅, all exclusion ✅, no R1-R5 trigger
- conditional: any inclusion ⚠️/❓ OR any exclusion ⚠️/❓ OR any R1-R5 trigger
- exclude: any inclusion ❌ OR any exclusion ❌ (hard exclusion)
5. Output the per-criterion table + verdict + rationale.
Hard rules (must apply)
| Rule | Trigger | Action |
|---|
| R1 | Trial excludes prior same-class drug AND patient has received that class | Demote match → conditional |
| R2 | Trial line policy < patient lines completed | Demote (1L hard limit → exclude; otherwise → conditional) |
| R3 | Trial's primary expansion indication is not patient's cancer type | Demote match → conditional |
| R4 | Patient organ function within ±10% of trial threshold | Demote match → conditional |
| R5 | ≥2 ❓ on critical inclusion criteria | Demote match → conditional; list fields to obtain |
Output schema
See rules/output-gating-verdict-schema.md for the full JSON contract.
Calling convention
This subskill is invoked by the parent clinical-trial-matching skill via Agent dispatch:
Agent(subagent_type="general-purpose",
description="trial-gater batch (5 trials)",
prompt="Use the trial-gater skill (skills/trial-gater/SKILL.md).
Evaluate the following 5 trials against the patient.
Trials JSON: <inline> | Patient JSON: <inline>
Output verdict JSON per rules/output-gating-verdict-schema.md.")
For interactive testing: invoke directly with Skill(skill="trial-gater", args="...").
Reference: rules
