Diabetes Trials Could Include Hypoglycemia As Patient-Reported Outcome
Executive Summary
FDA, industry and patient advocates all want studies to move beyond HbA1c, but still need to develop common thresholds and definitions to support patient-reported outcomes in diabetes drug development.
You may also be interested in...
FDA Safety Meetings: Outpatient Drugs, Hypoglycemia Getting Limelight
US agency's events could address a touchy subject: how much responsibility does FDA have for preventing adverse events, and how much falls to physicians?
Quality-Of-Life, Emotional Well-Being Becoming Highly Utilized PROs In Diabetes Trials
Industry mostly using the patient-reported outcomes as exploratory endpoints.
Diabetes Trials Tend To Eschew Patient-Reported Outcomes
A Pink Sheet analysis finds that most Phase III diabetes studies are not using patient-reported outcomes, which still tend to lack standardized measurements.