Decisionmaking for Enrichment Clinical Trial Implementation: Effect of Trial Strategies on Operations and Revenues

• Activity Number: 163
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Feng Gao*+ and Hongliang Shi and Yanyan Zhu
• Companies: Millennium and Millennium and Millennium
• Keywords: enrichment clinical trial ; biomarker

Abstract

With a decently-performing biomarker, the enrichment clinical trial designs almost always win over the all comer designs in terms of sample size. However, smaller sample size itself is not sufficient to endorse the enrichment clinical trial design, which tends to have higher per patient cost and longer recruitment period due to screening. In this presentation we investigate from operational and commercial perspectives and study how enrichment strategy could impact trial length, trial cost, market share and revenue. This work provides critical information for clinical trial sponsors to decide whether the enrichment strategy should be adopted.