The FDA says it is developing a qualitative framework for benefit/risk analysis out of recent case studies that suggested five key considerations a regulator must think about — severity of condition, unmet medical need, clinical benefit, risk and risk management.
The project was described by drug operations research analyst Patrick Frey for a Regulatory Affairs Professionals Society annual meeting session in September.
He said it was conceptualized last year and has since been piloted with four retrospective reviews or case studies where the agency was faced with difficult decisions in benefit/risk assessments.
The framework is designed to capture “key factors” on the reviewer's mind when a benefit/risk assessment is made. It can be broadly applicable as a template and also includes a methodology for communicating the results to external and internal audiences.
“The framework is intended to provide structure to internal deliberations by helping to extract explicit information related to the key considerations,” Frey said. “And it can function as a living document, which is easily updated as new information becomes available.”
For the next six months, Frey said the FDA's drugs center plans to continue to keep road testing the framework with additional retrospective cases.