October 15 – 21, 2021
Forums › Topic Group 4 › harmonized DCR definition
Agree. And this DCR definition is not sufficiently validated to be a primary endpoint (as stated).
I agree that the clinical relevance of DCR will depend on disease type. It is somewhere, where patient input would be helpful.
want to differentiate between definition which includes duration v. clinical relevance, which is protocol-designated by statistical target.