Califf Pushes Improved Evidence Generation System
FDA commissioner Robert Califf continues to call for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e.g., ChatGPT and other competitors) it is just a matter of time before the agency receives its first “AI-assisted” marketing submission. “As we develop much better systems of evidence generation, data science and statistics form the bedrock of generating evidence from data and information,” he said in an online post. “The FDA has a talented and influential group of quantitative experts, but to regulate the information-rich, digital world of the future we need to make it a conscious focus. An effective organization for knowledge sharing and professional advancement is needed across the multiple professional disciplines with a role in quantitative analysis, data management and computer science.”
Califf’s post reminisced about his clinical practice days and his recognition of the need for higher-quality evidence generation to “ guide our decisions about health. There is now a consensus among many experts that while the early phases of medical product development could be more efficient, the system basically works. But the evidentiary basis for late phase to post-market evaluation needs to be upgraded to take advantage of the dramatically different information landscape.”
He said a joint project between FDA and the National Institutes of Health will look to develop a standard terminology to describe evidence generation methods. “I’m excited about the opportunity to contribute to a new infrastructure that will enable much more high-quality evidence to inform decisions,” he continued. You’ll hear much more about this during the upcoming year,” adding that FDA chief medical officer Hilary Marston is leading the effort that will work across other federal agencies.
Califf’s post also touched on FDA’s continued engagement with Congress to forge a regulatory pathway for lab-developed tests and to adequately regulate dietary supplements under a sought-after registration and listing requirements (see earlier story). He also repeated his observation that the agency needs to “tune up our advisory committee system in a way that enables our experts to get the best advice possible.”