TL41: Experiences with Zero-inflated Poisson or Negative Binomial Models in Clinical Trials or other types of Studies for Regulatory Submission Purposes
*Samir Lababidi, Center for Biologics Evaluation and Research  *Stan Lin, Center for Biologics Evaluation and Research  *Ross Pierce, Center for Biologics Evaluation and Research 

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This roundtable aims to exchange experiences with discrete counting models in the analysis (and perhaps also design) of studies conducted for regulatory submission purposes that have excessive zero counts in the study data. Ideas of alternative analysis approaches and model selection issues are welcome.