[Implementing new interventions and indications: the possible role for real world data]

In advising the preferred therapy for the individual patient the expected results of the proposed intervention and possible side effects are the most relevant considerations. However, predicting the results of an intervention is difficult, especially when well designed randomized clinical trials (RCT's) are lacking or not conclusive. Artificial intelligence (AI) algorithms based on routine clinical data (real world data) can support clinical decision making, but in daily practice AI is still scarcely used. In this article one large radiotherapy facility and two health insurers describe their joint opinion on the possible role of AI based on real world data as an aid in clinical decision making when evidence from RCT's is not available. The introduction of proton radiotherapy in The Netherlands is being used as case model for AI model based clinical decision making.