European practice: Well-established use of herbal medicinal products and clinical research

When a clinical trial is about specific efficacy of an active substance the randomised placebo-controlled trial (RCT) is the gold-standard. This is the background of the well-known hierarchy of evidence of Evidence Based Medicine (EBM) also. Well-established use (WEU) of a drug as defined by European law requires proven efficacy by definition. But, when the modalities of the WEU of a specific product are assessed at a certain point during the product's lifetime many other questions contribute to the total body of evidence relevant for this assessment. The talk outlines the background of this situation and shows in which different ways clinical research may contribute. In this broader view the RCT design is only one option among others depending on the research question. The assessment of WEU needs a broader perspective, beyond of what an RCT can deliver.