playbooks

home / skills / ontos-ai / skills-evaluator / clinical-trial-protocol-generation

clinical-trial-protocol-generation skill

/test-skills/clinical-trial-protocol-generation

This skill accelerates clinical trial protocol development by auto-generating modular, compliant, and standardized plans tailored to disease and study type.

npx playbooks add skill ontos-ai/skills-evaluator --skill clinical-trial-protocol-generation

Review the files below or copy the command above to add this skill to your agents.

Files (1)
SKILL.md
2.7 KB
---
name: clinical-trial-protocol-generation
description: 加速临床研究的方案开发
---
# 临床试验方案生成：加速临床研究的方案开发

此技能旨在通过自动化和智能化手段，辅助研究人员快速、准确地生成临床试验方案，从而加速临床研究的启动和执行。

## 核心功能

1.  **智能模板填充**：根据用户输入的试验类型、疾病领域、研究目的等关键信息，自动匹配并填充标准化的临床试验方案模板。
2.  **内容模块化生成**：将方案拆分为多个模块（如研究背景、研究目的、试验设计、受试者选择、干预措施、评估指标、统计分析等），用户可选择性生成或定制。
3.  **合规性检查与建议**：内置法规和指导原则知识库（如ICH GCP、NMPA/FDA相关要求），在方案生成过程中实时进行合规性检查，并提供修改建议。
4.  **术语标准化**：利用医学术语词典，确保方案中使用的医学术语标准化和一致性。
5.  **数据可视化辅助**：对于统计分析部分，可辅助生成样本量计算、随机化方案等的可视化图表或说明。
6.  **多版本管理与协作**：支持方案草稿的保存、版本控制和多用户协作编辑功能。
7.  **输出格式多样化**：支持将生成的方案导出为Word、PDF等常见文档格式。

## 使用方法

**触发**：

*   "生成临床试验方案"
*   "帮我写一个新药临床试验方案"
*   "开发一个针对[疾病]的[研究类型]临床方案"

### 示例交互

**用户**："生成一个针对II型糖尿病新药的III期临床试验方案。"

**技能**："好的，请提供以下信息：
1.  研究药物名称：
2.  主要研究终点：
3.  次要研究终点：
4.  目标受试者人群特征："

**用户**："药物名称为'XXX-001'，主要终点是糖化血红蛋白（HbA1c）的降低，次要终点包括空腹血糖、餐后2小时血糖、体重变化等。目标人群为成年II型糖尿病患者，HbA1c在7.0%~10.0%之间。"

**技能**："正在根据您提供的信息生成方案草稿。请稍候... 方案草稿已生成，请查看并进行修订。其中，统计分析部分建议采用[方法A]进行样本量计算，并采用[随机化方法B]进行随机分组。您是否需要进一步细化或调整？"

## 优势

*   **提高效率**：显著缩短临床试验方案的撰写时间。
*   **确保质量**：通过标准化模板和合规性检查，提高方案的质量和准确性。
*   **降低成本**：减少人工错误和返工，节约时间和资源。
*   **促进协作**：支持团队成员共同参与方案的开发和修订。
*   **知识沉淀**：将专业知识和法规要求内化到工具中，便于知识管理和传承。

Overview

This skill accelerates clinical trial protocol development by automating template-driven drafting, compliance checks, and collaborative versioning. It helps researchers produce consistent, regulator-aware protocols faster while preserving customization for specific diseases and study designs. The tool focuses on practical outputs like Word/PDF exports and visual aids for statistical planning.

How this skill works

The skill ingests basic trial inputs (disease area, study phase, endpoints, target population, interventions) and maps them to standardized protocol modules. It fills and assembles sections such as background, objectives, design, eligibility, interventions, endpoints, and statistical analysis. Built-in regulatory guidance flags compliance gaps and suggests edits, while terminology normalization and visualization tools support sample size and randomization planning.

When to use it

  • Draft a new clinical trial protocol from high-level study requirements
  • Generate or update specific protocol modules (eligibility, endpoints, analysis plan)
  • Perform automated compliance checks against ICH GCP and major regulator expectations
  • Produce exportable protocol documents for review (Word, PDF)
  • Collaborate with team members and track version history

Best practices

  • Provide clear, specific inputs for drug name, endpoints, and inclusion/exclusion criteria to improve draft accuracy
  • Iterate module-by-module: generate, review, and refine the design and statistical sections separately
  • Use the compliance suggestions as a starting point and consult regulatory specialists for final sign-off
  • Normalize terminology early by linking to your preferred medical dictionary to keep language consistent
  • Save drafts and use version tags for major edits to maintain auditability

Example use cases

  • Create a Phase III protocol template for a new diabetes drug and export a submission-ready draft
  • Replace or refine the statistical analysis section with tailored sample size calculations and visualization
  • Standardize protocol language across multiple studies in an oncology program using terminology normalization
  • Run an automated compliance pass to identify potential gaps before internal or external review
  • Collaboratively edit a protocol with tracked changes and export the approved version for filing

FAQ

Can this replace a regulatory review?

No. The skill provides compliance guidance and flags issues but does not replace formal regulatory review or legal sign-off. Use it to prepare higher-quality drafts for expert review.

What outputs are available?

Generated protocols can be exported to Word and PDF. Statistical outputs include sample size calculations and simple visualizations for randomization or power analysis.