Clinical trial versus real-world data: the fundamentals

Written by The Evidence Base

We evaluate clinical trial and real-world data, assessing some of their comparative benefits, challenges and appropriateness for use 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...

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