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14th DIA Japan Annual Meeting 2017

[V2-S4] How to Use Statistics Correctly - Understand the Meaning of P Values and Eliminate Misuse

    Session Chair(s)
      Yoichi M. Ito, PhD

      Yoichi M. Ito, PhD

      • The Institute of Statistical Mathematics , Japan
    There are many statistical perspectives that should be discussed in planning clinical trials and inferring their results. It is necessary to understand statistical methods and results (p value, summary statistics, etc.) correctly. Especially misuse will lead to incorrect interpretation of the results. In The ASA Statement on Statistical Significance and P-values (2016) presented six important principles. Meanwhile, the recommendation on reviewing the advertising method of medical drugs (October 22, 2014: Meeting of Health Labor Science Research Group) suggests about accuracy of product information brochures and advertisements provided by pharmaceutical companies after launch doing. DIA Statistics WS has conducted a statistical workshop for those who are not biostatistics experts engaged in drug development over five times. This session explains the concept of p-value interpretation and statistical methods based on the contents of that statistical workshop. In addition, we introduce points to be noted about the result display in product information brochures and advertisements.
      Ayano  Takeuchi, PhD

      General Commentary on Misuse of P-Value : According to ASA Statement on P-Values

      Ayano Takeuchi, PhD

      • Lecturer, Department of Preventive Medicine & Public Health, School of Medicine
      • Keio University, Japan
      Moriyuki  Miyasato, MBA

      Pitfalls Surrounding P-Value in Drug Development

      Moriyuki Miyasato, MBA

      • Director, Head of Biostatistics Dept., Quantitative Science Div., R&D
      • Janssen Pharmaceutical K.K., Japan
      Kazumasa  Takenouchi

      Providing Information on Medical Drugs with Consideration of Evidence Level

      Kazumasa Takenouchi

      • Senior Manager, Biostatistics Group, Data Science
      • Astellas Pharma Inc., Japan

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