The consistency of the US FDA’s web of guidances and precedents around the use of real-world evidence of efficacy helped Aetion construct a simple regulatory feasibility screening instrument addressing topics from the importance of established natural history to the need for objectively measurable primary endpoints that can help sponsors determine if an RWE-based strategy is worth pursuing.
A Quick Look At SURF
Aetion’s regulatory feasibility tool for real-world evidence of safety and efficacy is built on six questions:
- Does the product address a life-threatening or severely debilitating indication with unmet medical need?
“We’ve been doing systematic reviews of approvals that are publicly available,” Aetion head of scientific strategy Ulka Campbell said in...
