Exploring AI-H Budgeting Framework for Clinical Trial Financial Feasibility: A Conceptual Analysis

This working paper explores the conceptual feasibility of an AI-assisted budgeting framework (AI-H) for clinical trial financial planning. The framework aims to support operational feasibility assessments, scenario modeling and structured cost estimation by leveraging publicly available protocols, ICH M11 Schedule of Activities and generative AI technologies.

The paper is intended solely for academic, non-commercial and discussion purposes. All content is based on public sources. No proprietary, confidential or personal data has been used.

Key topics include:
• Financial feasibility in clinical trials
• Structured budgeting aligned with ICH E6(R3) and M11
• Use of AI in protocol interpretation and cost modeling
• Recommendations for improving Schedule of Activities (SoA) structure

This version has not been peer-reviewed and is made available under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).

Contact: dlinde (at) proton [dot] me