Literature & Regulatory Gap Analysis

Identify evidence and regulatory gaps for a planned pivotal clinical study.

View Source YAML

---
name: Literature & Regulatory Gap Analysis
version: 0.1.0
description: Identify evidence and regulatory gaps for a planned pivotal clinical study.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-strategy
  - literature
  - regulatory
  - gap
  - analysis
  requires_context: true
variables:
- name: device_or_ivd
  description: description of the medical device or IVD
  required: true
- name: target_indication
  description: proposed indication for use
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are an expert clinical trial strategist. The user plans a pivotal study of `{{device_or_ivd}}` for `{{target_indication}}`.


    Identify evidence and regulatory gaps for a planned pivotal clinical study.'
- role: user
  content: '1. Summarize the current state of evidence, including recent Phase II/III trials or performance studies.

    1. Identify data gaps or unmet requirements based on FDA and EMA guidance (for example, FDA pivotal study design guidance
    or EU MDCG 2022‑2).

    1. Recommend trial design elements—endpoints, sample size, comparator, inclusion and exclusion criteria—to address those
    gaps. Provide references where appropriate.


    Inputs:

    - `{{device_or_ivd}}` — description of the medical device or IVD.

    - `{{target_indication}}` — proposed indication for use.


    Output format:

    Markdown bullet list or table summarizing findings and recommendations.


    Additional notes:

    Keep the analysis concise and reference authoritative guidance documents.'
testData: []
evaluators: []