inclusion-criteria-gen

What This Skill Does

The inclusion-criteria-gen skill is an advanced clinical trial design assistant designed to streamline the complex process of developing patient eligibility criteria. By leveraging clinical data and trial parameters, it helps researchers balance the often-conflicting goals of scientific rigor and patient recruitment feasibility. This tool automates the drafting of inclusion and exclusion criteria based on study protocols, optimizes existing criteria to improve enrollment rates without compromising safety, and provides competitive benchmarking to ensure a trial remains attractive to potential participants compared to other active studies in the same space.

Installation

To integrate this skill into your environment, use the OpenClaw command-line interface. Ensure you have the necessary permissions for repository installation.

clawhub install openclaw/skills/skills/aipoch-ai/inclusion-criteria-gen

Use Cases

• Protocol Design: Generate baseline eligibility criteria for new phase I-IV trials based on trial design parameters.
• Criteria Optimization: Analyze underperforming trials and adjust inclusion/exclusion criteria to remove unnecessary bottlenecks, aiming to hit enrollment targets faster.
• Competitive Intelligence: Assess how your study requirements compare to existing trials for a specific indication to ensure you are not unnecessarily restricting your subject pool.
• Feasibility Assessment: Use the tool to simulate how certain restrictions might impact your potential patient population size.

Example Prompts

1. "Generate a set of inclusion and exclusion criteria for a Phase 2 trial focused on Type 2 Diabetes for adults aged 18-75, ensuring focus on HbA1c reduction and weight change metrics."
2. "We are currently at 120 enrollments against a target of 200 for our cardiovascular study. Analyze these criteria and suggest three modifications to broaden the eligibility pool safely."
3. "Benchmark my current eligibility criteria against competitor trials for Chronic Kidney Disease and identify any exclusionary criteria that are stricter than the industry standard."

Tips & Limitations

• Data Quality: The quality of generated criteria is directly proportional to the accuracy of your input parameters. Always ensure your study duration, phase, and endpoints are clearly defined.
• Human Oversight: This tool is an assistant; clinical trial criteria must always be reviewed by medical monitors and regulatory experts for final compliance with local safety standards and ICH-GCP guidelines.
• Scope: While the tool can identify recruitment bottlenecks, it cannot account for external site-specific logistical issues that may impede enrollment. Always use in conjunction with site-level feasibility data.