Integrating Evidence Strategies at Every Level to Improve Patient Outcomes

With the recent rise of real-world evidence (RWE) and non-traditional clinical trial formats in regulatory and market access decision-making, developing effective integrated evidence generation strategies has become a priority for all stakeholders in therapeutic development. The complexities of the modern evidence generation process are laid out in a recent Pharmaphorum article by experts from Fishawack Health.

According to the article, “To meet patients’ needs for effective therapies, regulatory bodies have begun accepting evidence beyond large, randomized, controlled clinical trials and have developed novel pathways to accelerate approval. This has led to an increase in products coming to market with single‑arm Phase 3 data and surrogate endpoints or Phase 2b data, with planned confirmatory data to be released in the future. As a result, payers face high levels of uncertainty when determining the relative efficacy and cost‑effectiveness of the product”

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(Source: Pharmaphorum, December 8^th, 2022)