Over the past few decades, the pharmaceutical industry has shifted its focus to areas of high unmet need
Such as treating cancer and rare diseases
For many of these conditions, traditional approaches to clinical trial design fall short
The transition therefore calls for innovative clinical and regulatory strategies that can deliver new drugs fast
Advanced digital technologies now offer unprecedented opportunities to improve drug development and, by extension, patients’ lives
These include capturing patient-reported outcomes
facilitating accelerated regulatory approval pathways
analyzing real-world data
and using intelligent analytics solutions
While the tools and practices for unlocking the potential of innovation abound
pharma is only in the early stages of adapting them at scale
Aligning the needs of patients, providers, payers, and regulators will require biopharma organizations to adapt and evolve
And leveraging digital tools, data, and analytics could help them get there
Lee et al. “Innovation in Regulatory Science is Meeting Evolution of Clinical Evidence Generation.” Clinical Pharmacology & Therapeutics (2019)