Asuntos regulatorios farmacéuticos: acceso abierto

Regulations on Adaptive Design Clinical Trials

Abstract

Yuanxin 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 described respectively in order to account for the differences in regulatory impact and concerns. The strategic regulatory, statistical and operational considerations on how to use adaptive design are presented. It is hopeful that more innovation and collaboration made by the industry, academia, and regulatory agencies could promote the application of adaptive designs and transform the drug development.