Simulation Practices For Adaptive Trial Designs In Drug And Device Development

AbstractAdaptive clinical trials are the cornerstone of modern drug and device development. The most recent US legislation calls for higher efficiency in designing clinical trials with emphasis on expanding the utilization of complex innovative designs that cannot be developed without simulations. It is well recognized that clinical trial simulation is a fundamental tool to explore, compare and understand the operating characteristics, statistical properties, and adaptive decisions embedded in different designs to answer the given research questions. This paper provides insights from industry on the development of a simulation report from a group of statisticians brought together under the sponsorship of the Drug Information Association Adaptive Design Scientific Working Group. This effort intends to illustrate the key common elements required to ensure higher consistency and clarity in conducting and reporting simulations of adaptive clinical trials, eliminate unnecessary barriers in communicating techni...