Table 1

Comparison of simplified phases of evaluation of a drug versus artificial intelligence (AI) in healthcare

Study phasesDrugAI in healthcare44–46
Phase 0 preclinical/discoveryCompound/drug target development
Preclinical/lab studies
Proof-of-concept studies (usually on a static/retrospective dataset)
Algorithm development and performance metrics evaluation
Phase I safetySafety assessment
Evaluating metabolism and optimal therapeutic dosage
Adverse effects
Feasibility to implement into an existing workflow
‘Real world’ evaluation of algorithm performance
Safety evaluation
Phase II efficacy and safetyProspective efficacy and safety evaluation/clinical trial (in a larger study group, >100 patients with controls)Prospective efficacy and safety evaluation/ clinical trial (in a larger study group, potentially multi-departmental or hospital-wide)
Phase III therapeutic efficacyEfficacy and safety clinical trial (>1000 patients with controls)
Medium to long term adverse event monitoring
Efficacy and safety clinical trial (potentially hospitalwide or multitrust, with controls)
Medium-term to long-term performance evaluation compared with control/existing non-AI workflows
Phase IV safety and effectivenessPostmarket surveillancePostdeployment surveillance