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Diabetes Trials Could Include Hypoglycemia As Patient-Reported Outcome

 
• By Michael Cipriano

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.

HbA1c remains the gold standard biomarker for scoring FDA approval for a diabetes drug, but regulators, industry and patient advocates all agreed that there must be further discussions to identify a series of patient-reported outcome tools, definitions and thresholds related to the disease to develop more effective treatments.

Although the benefits of a surrogate endpoint like glycated hemoglobin can be established in smaller and shorter-term trials, the results carry a high degree of uncertainty and fail to capture...

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