Pharmaceutical Regulatory Affairs: Open Access

Yuanxin Rong

Publications

• Review Article
  Regulations on Adaptive Design Clinical Trials
  Author(s): Yuanxin RongYuanxin Rong
  
  In recent years, adaptive designs have recaptured attentions in the clinical research society as they can improve the flexibility and efficiency of conducting a clinical trial and increase the chance of trial success. However, adaptive trials are complex to design and often accompanied with various degrees of statistical, procedural, logistic and regulatory challenges. This article provides a general overview of adaptive designs with attentions to the discussion on the basic concepts, classification, application scope and principles with current understanding of regulatory agencies throughout the article. The adaptive designs in the exploratory, seamless and confirmatory stages are separated discussed with some common types briefly d.. Read More»
  DOI: 10.4172/2167-7689.1000116

  Abstract PDF