trial-gater

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": { /* see clinical-trial-matching SKILL.md Step 1 schema */ }
}

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

• R1: prior same-class drug — most-violated rule in v1.7.x
• R2: treatment line mismatch
• R3: indication scope
• R4: organ function borderline
• R5: missing critical fields
• Output schema