Clinical trial versus real-world data: the fundamentals

We discuss clinical trial and real-world data, assessing some of their benefits, challenges and potential uses in healthcare decision-making. The term ‘gold standard’ has scarcely been used as an adjective for anything more than it has for traditional, randomized controlled trial data in the context of demonstrating the effectiveness of an intervention and seeking regulatory approval. Increasingly, however, calls have been made for guidance on when and how real-world data may be considered in healthcare decision-making. In this article, we will explore the ‘what’, ‘how’s and ‘when’s of both clinical trial and real-world data and evidence, to determine some of...