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課程介紹
Planning a clinical research project requires expertise from multi-disciplines. Each discipline provides input that is essential to the research. Statistics is one of the disciplines that is critical to the planning, execution, analyses, and conclusion of the research.  With statistical input, it minimizes the study bias, performs appropriate and valid statistical analyses, and defines clinical research outcome quantitatively. This workshop will discuss the statistical-related elements in clinical research in 2 sessions in 2 separate 2 workshops. The first session will cover study design and conduct of clinical research; the second session will cover data analyses and other special topics such as adaptive design at later time.
 

課程資訊

課程日期:2018年02月05日(一) 14:00~17:00  2018年02月06日(二) 09:30~12:00

課程地點:台北醫學大學大安校區B201會議室

主辦單位:臺北醫學大學生物統計研究中心

協辦單位:臺北醫學大學人體研究處、TMU-JIRB

※授課完畢將獲得3個小時IRB時數

講師簡介

葉瓊華Chyon-Hwa Yeh, Ph.D. 

Statistician, MED Institute West Lafayette, IN

Education

Ph.D. in Statistics, Texas A&M University, College Station, TX

Experiences

ü  1991/11-2011/03 Statistician, The Procter & Gamble Company, R&D

ü   Project statistician

Nutrition and Health for Companion Animals (2008-2011)

Global Asacol-Ulcerative Colitis and GI program (1999-2009)

Global Pexizilimub-CABG program (2004-2008)

Global cardiac-Azimilide-SVA program (2000-2004)

Gglobal periodontitis prevention program , OTC oral care in Asia/Pacific regions (1996-2000)

Pharmaceutical compound discovery and pharmacokinetic research in respiratory, GI, and cardiac (1991-2009) 

 

課程大綱

Statistics in Clinical Research – Part I

  1. Overview of Clinical Research
  2. Statistical-Related Elements in Clinical Research
    1. Study Design
      1. Study Objectives
      2. Statistical Hypothesis
      3. Study Population
      4. Selections of Study Groups
      5. Efficacy and Safety Endpoints
      6. Study Procedures and Schedules
      7. Sample Size Determination
      8. Applications of Meta Analyses in Clinical Studies
    2. Conduct of Clinical Research
      1. Randomization and Blinding
      2. Interim Analyses and Unblinding
      3. Confounding Effects on Study Outcome

Statistics in Clinical Research – Part II

  1. Data Analyses
    1. Subject Disposition
    2. Analysis Datasets
    3. Efficacy Endpoint(s)
    4. Safety Endpoints
    5. Subgroup Analyses
    6. Missing Data and Outliers
    7. Sensitivity Analyses
  2. Additional Topics on Data Analyses
    1. Adaptive Study Designs
    2. Interim Analyses 
    3. Exploratory Analyses
 

報名資訊

線上報名連結: http://event.tmu.edu.tw/actnews/signup.php?Sn=2885

開始日期 2018-02-05 14:00:00

結束日期 2018-02-06 12:00:00

 

聯絡資訊

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