Real world evidence and pharma

4 July 2017

Randomized control trials (RCTs) have long been the gold standard for assessing the efficacy and safety of new drugs, but there is an increasing desire among stakeholders for evidence of how drugs work in the real-world, not just within the confines of a highly controlled experimental environment.

No longer is Food and Drug Administration (FDA) approval the ultimate goalpost. As drug prices rise, so resistance becomes more entrenched from government, payer organizations and the patients themselves. Stakeholders now want real world evidence (RWE) of a drug’s true performance and effectiveness before they make final decisions about pricing and payment.1

What exactly is RWE?

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