Issues in Planning and Conduct of Sample Size Re-Assessment in Medical Device Trials

• Activity Number: 546
• Type: Contributed
• Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Laura Lu*
• Companies: FDA/CDRH
• Keywords: adaptive design ; sample size re-assessment ; pre-planning ; medical device

Abstract

Sample size re-assessment is gaining popularity in clinical trials in recent years due to the practical reason and maturity of methodology. In the medical device industry, adaptive design is especially appealing as there is usually limited human data available before a pivotal study is designed for making assumptions on treatment effect. Although the methodologies on sample size re-assessment are well developed, additional issues in practice exist due to the complexity in planning and execution of adaptive trials. In this presentation, examples will be provided to address issues we see in sample size re-assessment in medical device trials. We will stress the importance of pre-planning, consistency between trial design, conduct and analysis, and early communication between industry and FDA.