Charting a path forward for clinical research in artificial intelligence and gastroenterology

Area of Science:

• Gastroenterology
• Medical Artificial Intelligence (AI)
• Clinical Trial Methodology

Background:

• Gastroenterology has pioneered the integration of artificial intelligence (AI) into clinical trials.
• Rapid advancements in AI for clinical medicine necessitate standardized guidance for AI-specific study design and reporting.
• Existing initiatives include AI-specific reporting guideline amendments and task force recommendations for AI use cases.

Purpose of the Study:

• To examine the application of AI in gastroenterology clinical trials.
• To discuss AI-specific extensions to established clinical trial reporting guidelines.
• To review pre-trial AI applications and identify areas requiring further guidance.

Main Methods:

• Review of AI applications in gastroenterology clinical trials.
• Analysis of AI-specific extensions to Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).
• Exploration of pre-trial AI use cases in endoscopy and other gastroenterology subfields.

Main Results:

• Gastroenterology is at the forefront of AI integration and validation in clinical trials.
• New AI-specific reporting guidelines are emerging to address the complexities of AI in research.
• Further guidance is needed for pre-trial AI applications in various gastroenterology areas.

Conclusions:

• Standardized reporting and study design are crucial for advancing AI in gastroenterology clinical trials.
• The development of AI-specific guidelines is essential for robust clinical validation.
• Continued research and guideline development are needed to optimize AI's role in gastroenterology.