EXAMPLE:LIDOCAINE IN ACUTE MI LIDOCAINE HO 10 mg/mL BIOLOGICAL INTERMEDIATE ULTIMATE MARKER ENDPOINT OUTCOME VENTRICULAR VENTRICULAR SURVIVAL ECTOPY FIBRILLATION 11
EXAMPLE: LIDOCAINE IN ACUTE MI BIOLOGICAL INTERMEDIATE ULTIMAT E 11 MARKER ENDPOINT OUTCOME VENTRICULAR VENTRICULAR SURVIVAL ECTOPY FIBRILLATION 11
SURROGATE ENDPOINT A biomarker intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm,or lack of benefit)based on epidemiologic,therapeutic,pathophysiologic or other scientific evidence. 12
A biomarker intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical SURROGATE ENDPOINT 12 benefit (or harm, or lack of benefit) based on epidemiologic, therapeutic, pathophysiologic or other scientific evidence
SURROGATE ENDPOINT A surrogate endpoint is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels,functions or survives.Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. 13
SURROGATE ENDPOINT A surrogate endpoint is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by 13 a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint
EXAMPLES OF PHYSIOLOGIC ENDPOINTS THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME antihypertensive b.p. stroke drugs for glaucoma i.o.p. loss of vision osteoporosis drugs 个bone density fracture rate antiarrhythmic arrhythmias 个survival 14
EXAMPLES OF PHYSIOLOGIC ENDPOINTS THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME 14 antihypertensive b.p. stroke drugs for glaucoma i.o.p. loss of vision osteoporosis drugs bone density fracture rate antiarrhythmic arrhythmias survival 14
EXAMPLES OF LABORATORY ENDPOINTS THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME antibiotics neg.culture clinical cure anti-diabetic blood glucose morbidity lipid lowering drugs cholesterol CAD drugs for prostate ca PSA tumor response anti-HIV drugs 个CD4;viral RNA AlDs suppressed 15
EXAMPLES OF LABORATORY ENDPOINTS THERAPEUTIC BIOMARKER/ CLINICAL CLASS SURROGATE OUTCOME antibiotics neg. culture clinical cure 15 anti-diabetic blood glucose morbidity lipid lowering drugs cholesterol CAD drugs for prostate ca PSA tumor response anti-HIV drugs CD4; viral RNA AIDs suppressed 15