Shift from surrogate end point to outcome trials: implications for cardiovascular safety assessment in development programs for antidiabetic drugs - Marcinak, J F; Viswanathan, P; Arora, V; Roebel, L E; Strack, T R; Leifke, E (Clinical pharmacology and therapeutics, 2012)
Keywords: Biomarkers - analysis; Cardiovascular Diseases - chemically induced; Clinical Trials, Phase III as Topic - methods; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Endpoint Determination - methods; Follow-Up Studies; Hospitalization; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Outcome Assessment (Health Care); Prospective Studies; Randomized Controlled Trials as Topic - methods; Risk Factors