Some Group Sequential Trials from Industry over the Last 30 Years

Abstract

We consider several industry group sequential trials and associated issues over the last 30 years. Generally, group sequential design has provided a great deal of flexibility to overcome many challenges in a relatively straightforward way compared to more complex adaptive designs. Among the issues considered are the timing of and boundaries for interim and final analyses, dealing with multiple hypotheses created by dose groups, populations and endpoints. Tools for design and execution will also be discussed.

Keywords:

• Adaptive design
• Clinical trials
• Futility
• Group sequential design

Acknowledgments

The authors gratefully acknowledge the many contributors to trials discussed in this article as well as those contributing to the software packages used.

Disclosure Statement

Keaven Anderson, Yujie Zhao, Nan Xiao, and Joy Ge are employees of Merck & Co., Inc. Harlan Weisman is an consultant in the healthcare industry.

Table 1 EPIC results at final analysis.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.