Leveraging Patient Registries to Assess Safety and Product Performance in the Post-approval Arena

Leanne R. Larson, MHA • Vice President, Registry Consulting • ICON Clinical Research • Lifecycle Sciences Group

The drug development path today is more challenging and expensive than ever. The cost of bringing a new drug to market is estimated at somewhere between $500 million and $1 billion. With this intense development investment, it’s critical, then, for the drug to remain on the market after approval—an outcome that is not nearly as certain today as it was in decades past.

Indeed, the post-approval world that products and sponsors now face is fraught with complex—and shifting—requirements, guidances, and market forces. And these forces and demands are shaping the way sponsors approach both their research programs and their commercialization plans.

Growing Market Demand

The demand for post-approval information is being driven by a global need for real-world data on product safety, patient outcomes, and even treatment costs—by regulators, payors, and providers alike.

Most notably, FDA- and EMEA-initiated safety-surveillance mandates have increased significantly
in recent years; going forward, it’s expected that most all products gaining regulatory approval
will have at least one post-market commitment imposed. 2006 FDA data show, in fact, that 1,259
open commitments are currently held by only 127 companies—almost 10 commitments each.

The demand crosses over into payor and provider sectors as well, with growing need for global data on real-world outcomes to support prescribing, formulary, coverage, and pricing decisions by both
public and private payors worldwide.