Clinical Trial Stopping Rules in the Context of Conservative Regulatory Guidance

• Activity Number: 443
• Type: Topic Contributed
• Date/Time: Wednesday, August 6, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Keaven Anderson*+
• Companies: Merck
• Keywords: clinical trials ; group sequential design ; interim monitoring ; regulatory guidance

Abstract

Regulatory guidance suggests minimizing the number of interim analyses and conservative bounds for stopping. Given this guidance, we examine some ways to evaluate and select bounds taking into account timing/sample size, and degree of evidence as indicated by alpha- and beta-spending, approximate treatment effect required to cross bounds. Spending functions to address these issues will be discussed. In addition, multiplicity issues raised by evaluating multiple endpoints will be discussed in the context of recent methods development. Finally, questions regarding regulatory guidance will be raised for discussion.