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1. Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes.

Author

Geiger, Mary Jane, Mehta, Cyrus, Turner, J. Rick, Arbet-Engels, Christophe, Hantel, Stefan, Hirshberg, Boaz, Koglin, Joerg, Mendzelevski, Boaz, Sager, Philip T., Shapiro, Deborah, Stewart, Murray, Todaro, Thomas G., and Gaydos, Brenda

Subjects
CARDIOVASCULAR diseases risk factors, HYPOGLYCEMIC agents, LONGITUDINAL method, RESEARCH methodology, MEDICAL societies, TYPE 2 diabetes, STATISTICS
Abstract

The article discusses statistical methodologies and clinical development approaches to prospectively evaluate the cardiovascular (CV) risk of new antidiabetic treatments for Type 2 diabetes. It mentions the guidance from the U.S. Food and Drug Administration (FDA) and European MedicinesAgency (EMA) for assessing safety of antidiabetic therapies. It states that the sponsors of drug trial should compare the incidence of major CV events before submission of a new drug application.

Published
2015
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