Can real-world evidence save pharma US$1 billion per year? A framework for an integrated evidence generation strategy

Summary

Evidence generation by the pharmaceutical industry is typically sequential and siloed. While this one-size-fits-all approach was previously adequate for regulatory decision-makers, it is no longer fit for purpose. External factors, such as increasing regulatory requirements for real-world data, the growing role of payer- and patient-relevant end points in reimbursement decisions and rising constraints on healthcare budgets, require a new and integrated approach. This article builds on the previous ‘call to action’ to transform the mindset of the pharmaceutical industry in utilizing real-world evidence by presenting an evidence-powered operating framework for applying an integrated evidence generation strategy within a pharma organization.