Bringing in real-world evidence into regulatory and clinical environments in an “efficient and timely manner” requires “disruptive innovation within the regulatory infrastructure,” according to a Health Affairs blog post.
The blog post, authored by Anirban Basu, who has consulted with biomedical companies, nonprofits and payers, was published Nov. 2.
“The key challenge lies in curating real-world evidence to ensure the right regulatory decisions can be made with that evidence,” Basu writes.