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Join us at Symposium 1:

Unbiased Treatment Effect and Meaningful Change Detection in the Presence of PRO Missing Data: Updating Historical Practices to Improve Oncology Outcomes

Tuesday, 22 October | 11:00 am – 12:15 pm in room Grande AB

Join us for an in-depth examination of missing data in patient-centered outcomes. Both consequences and solutions will be discussed. Pharmerit has developed new methodological solutions to missing data in meaningful change and treatment efficacy. This symposium will demonstrate how missing data bias can be remediated. Emphasis will be made throughout on how these solutions fit into current regulatory guidance.

MODERATOR:
John Fastenau, PhD, Janssen, Raritan, NJ, United States

DISCUSSANT:
Scott Komo, DrPH, United States Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, United States

INDIVIDUAL PRESENTATIONS:

  • Compliance Rules in Daily Diary Data: Avoiding Reductions in Power and Treatment Efficacy Bias
    R.J. Wirth, PhD and James McGinley, PhD, Vector Psychometric Group, LLC, Chapel Hill, NC, United States
  • Estimating Meaningful Change in the Context of Covariate-dependent Drop-out
    Daniel Serrano, PhD, Pharmerit International, Bethesda, MD, United States
  • PROs in Survival Analysis and Detection of Treatment Efficacy
    Charles Iaconangelo, PhD, Pharmerit International, Brooklyn, NY, United States