Drug Designing: Open Access

Drug Designing: Open Access
Open Access

ISSN: 2169-0138


Shein-Chung Chow

  • Research Article
    A Note on Design and Analysis of Clinical Trials
    Author(s): Shein-Chung Chow and Shih-Ting ChiuShein-Chung Chow and Shih-Ting Chiu

    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 futu.. Read More»
    DOI: 10.4172/2169-0138.1000102

    Abstract PDF

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