alexa A Note on Design and Analysis of Clinical Trials
ISSN: 2169-0138

Drug Designing: Open Access
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Research Article

A Note on Design and Analysis of Clinical Trials

Shein-Chung Chow1 and Shih-Ting Chiu1,2*
1Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
2National Taiwan University, Taipei, Taiwan
Corresponding Author : Shih-Ting Chiu
Department of Biostatistics and Bioinformatics
Duke University School of Medicine
2424 Erwin Road, Hock Suite 1102
Room 11069, Durham
North Carolina, USA
E-mail: [email protected]
Received December 17, 2012; Accepted February 18, 2013; Published February 21, 2013
Citation: Chow SC, Chiu ST (2013) A Note on Design and Analysis of Clinical Trials. Drug Des 2:102. doi:10.4172/2169-0138.1000102
Copyright: © 2013 Chow SC, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 

Abstract

Most countries have adopted the good clinical practice (GCP) principles as laws and regulations for approving clinical trials which are conducted to test new methods to prevent, detect, and treat disease or drug development. Most regulatory agencies such as the United State Food and Drug Administration (FDA) indicate that only adequate and well-controlled clinical trials can provide substantial evidence of safety and effectiveness of the test treatment under investigation. FDA indicates that “substantial evidence” can only be provided through “adequate and wellcontrolled” clinical investigations which include valid study design and appropriate statistical methods for data
analysis. In this article, we are going to highlight the key points in design and analysis of clinical trials. We will also review the current research and point out the issues for future research.
Few commonly employed study designs and its concepts in clinical trials will be described. In addition, statistical methods for data analysis on efficacy and safety are reviewed. To maintain the integrity and quality of the intended trial, Good Clinical Practice (GCP) and independent Data Monitoring Committee (DMC) are also discussed. Recent development such as biomarker development for target clinical trial, translational research/medicine, and traditional Chinese medicine are also provided.

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