Clinical trial designs for artificial intelligence in gastrointestinal endoscopy

Gastrointestinal endoscopy has been a leader in using artificial intelligence in medicine; more than 15 randomised trials have been published in the past 4 years, many with encouraging results that affect both clinical practice and regulatory approval. However, the quality of clinical trials varies substantially and there are currently no guidelines for quality grading of clinical trials. In this Comment, we describe opportunities and challenges of trial design for artificial intelligence in medicine, with the example of artificial intelligence-assisted colonoscopy.