Real World Evidence
Meet your clinical, economic, and regulatory needs throughout a product's lifecycle using U.S. real world solutions.
Case Study
Expedited Label Expansion for a Cancer Drug Using Real-World Evidence (RWE)
Apr 25, 2025
In a recent endeavor, a pharmaceutical customer sought to expand the labeling of its cancer drug to include a new patient population. However, the traditional route of conducting Randomized Clinical Trials (RCTs) was not feasible due to the low number of patients in this specific population. This presented a significant challenge: how to provide sufficient evidence to the FDA to support the label expansion without relying on RCTs.
Faced with this challenge, the customer turned to IQVIA's Regulatory Science and Strategy team for an innovative solution. The team recognized that an alternative approach was necessary to demonstrate the drug's efficacy and safety in the new population. Leveraging Real-World Evidence (RWE) became the cornerstone of their strategy.
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Regulatory and Safety
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