How Do You Address The FDA Guidance On Integrated Summary Of Effectiveness (ISE)?

A: IN THE AGE OF PRECISION MEDICINE, we are encouraged by regulators to focus on diversity. Achieving true diversity provides a field day for statisticians (e.g., give me six of these and six of those). Effectively requiring a quota system for patient entry might be achievable if there were enough research sites truly serving a diverse population. But in the age of specialization, this is not the reality. I can only reach all of the desired patient groups by significantly increasing the number of qualified research sites in the trial, and this brings its own set of issues described in another guidance document on the perils of working with small numbers. This brings me full circle to another of my old favorite solutions, the post-approval commitment — perhaps the only way to demonstrate which patients benefit.

MARY ROSE KELLER
Mary Rose is VP clinical operations at Heron Therapeutics. She has 30+ years of industry experience in clinical development strategy and execution of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products.