trial-eligibility-agent

$npx mdskill add swaruplab/operon/trial-eligibility-agent

Parses trial protocols and patient data to produce criterion-level eligibility determinations.

  • Solves the problem of manually screening patients for clinical trial eligibility.
  • Depends on ClinicalTrials.gov, FHIR bundles, and file reading tools.
  • Evaluates each criterion by mapping patient facts to protocol thresholds.
  • Outputs a structured table with MET/NOT/UNKNOWN status and evidence citations.

SKILL.md

.github/skills/trial-eligibility-agentView on GitHub ↗
---
name: trial-eligibility-agent
description: Parse trial protocols and patient data to produce criterion-level MET/NOT/UNKNOWN determinations with evidence and gaps for clinical trial screening tasks.
allowed-tools:
  - read_file
  - run_shell_command
---

## At-a-Glance
- **description (10-20 chars):** Trial triage hub
- **keywords:** eligibility, ClinicalTrials, FHIR, evidence, gaps
- **measurable_outcome:** Produce a MET/NOT/UNKNOWN matrix with supporting citations for ≥90% of inclusion/exclusion criteria within 5 minutes per trial request.

## Inputs
- `trial_id` (NCT or sponsor ID) plus protocol text if not public.
- `patient_summary` narrative and optional `patient_structured` FHIR bundle.
- Declare data sources used (notes, labs, imaging, meds) to show provenance.

## Outputs
1. Structured table (JSON recommended) listing each criterion id/text with status, evidence snippet, and confidence.
2. Overall recommendation (`potentially_eligible`, `not_eligible`, `needs_more_information`).
3. Data gap checklist covering missing labs/imaging/biomarkers.

## Workflow
1. **Acquire protocol:** Pull eligibility text from ClinicalTrials.gov or sponsor PDF.
2. **Normalize criteria:** Break into atomic checks with AND/OR logic and thresholds.
3. **Extract patient facts:** Map narrative + FHIR data into canonical features (age, labs, ECOG, biomarkers).
4. **Evaluate:** Assign MET/NOT/UNKNOWN with cited evidence for each criterion, flag missing context explicitly.
5. **Summarize:** Present recommendation and highlight gating unknowns plus next-best actions.

## Guardrails
- Never claim enrollment decisions; mark outputs as advisory.
- Cite direct patient evidence for every MET/NOT call; default to UNKNOWN rather than guessing.
- Respect PHI handling expectations—avoid storing raw notes outside secure paths.

## Tooling & References
- Use `README.md` for API snippets (FHIR parsing, JSON schema) and dependency versions.
- Pair with `Clinical/Trial_Matching/TrialGPT` when retrieval/ranking is also needed.

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