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DIA 2018 Global Annual Meeting


Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making

    Session Chair(s)
      Ankit  Pahwa, MS

      Ankit Pahwa, MS

      • Manager, Biostatistics
      • BioClinica, India
    Regulators expect drug makers to conduct novel studies to provide treatment effectiveness results that are valid in everyday clinical practice. This session will present opportunities and challenges in pragmatic trials to generate real-world insights.
    Learning Objective : Discuss the usefulness of pragmatic clinical trials to support regulatory decision making and shortening drug approval time; Describe how pragmatic trials offer avenue to obtain real-world data to support comparative effectiveness research; Describe design and statistical considerations for pragmatic trials to produce acceptable, valid, precise, and generalizable results.
    Speaker(s)
      Ankit  Pahwa, MS

      Real-World Evidence in Regulatory Decision Making

      Ankit Pahwa, MS

      • Manager, Biostatistics
      • BioClinica, India
      Jennifer Hsiang-Ling  Lin, PhD

      Design and Statistical Considerations in Real-World Evidence

      Jennifer Hsiang-Ling Lin, PhD

      • Associate Director, RWE Design and Analytics
      • Janssen Pharmaceuticals, United States
      David  Thompson, PhD

      Pragmatic Clinical Trials: The Future is Now

      David Thompson, PhD

      • Senior Vice President, Real World and Late Phase Research
      • Syneos Health, United States