Clinical End Points in Coronary Stent Trials
Background— Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of asse...
Publications
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17 publications
Modified RECIST (mRECIST) Assessment for Hepatocellular Carcinoma
The endpoint in cancer research is overall survival. Nonetheless, other potential surrogate endpoints, such as response rate and time to progression, are currently used. Measure...
Trastuzumab — Mechanism of Action and Use in Clinical Practice
Overexpression of human epidermal growth factor receptor type 2 (HER2) in breast cancer is associated with decreased overall survival. Trastuzumab, a humanized monoclonal antibo...
Development of therapeutic antibodies for the treatment of diseases
Abstract It has been more than three decades since the first monoclonal antibody was approved by the United States Food and Drug Administration (US FDA) in 1986, and during this...
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the ...
Characteristic Physical Properties and Structural Fragments of Marketed Oral Drugs
An increasingly competitive pharmaceutical market demands improvement in the efficiency and probability of drug candidate discovery. Usually these new drug candidates are target...
Food and Drug Administration requirements for approval of new anticancer drugs.
For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and ...
University Group Diabetes Program
<h3>To the Editor.—</h3> As a minor participant in the University Group Diabetes Program (UGDP), I think that the compelling reason for the study apparently has been lost (1) in...