Real-world evidence use is expanding. What’s behind the change?


In the rapidly evolving landscape of drug development, real-world evidence (RWE) is making significant strides, finding its way into the early stages of the process. No longer confined to just the peri- and post-approval phases, RWE is now being tapped for external control arms (ECAs), aiding in health technology assessment (HTA), and informing payer discussions.

To maintain their competitive edge, biopharma executives need to develop a comprehensive early data strategy, noted executives from Evidera, part of the PPD clinical research business of Thermo Fisher Scientific, in a recent Q&A. This strategy should focus on carefully selecting and effectively harnessing real-world data (RWD) to support regulatory and HTA approvals.

The use of RWE, however, is not without challe…

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