Improving the Operational Efficiency of Phase II and III Trials

• Activity Number: 435
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jitendra Ganju*
• Companies: Hyperion Therapeutics
• Keywords: alpha spending ; unblinding ; trial efficiency ; DSMB

Abstract

The period toward the end of patients' participation in late stage clinical trials is highly resource intensive for sponsor. If the trial is a success, the sponsor has to implement the next steps which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and submission of the package to the FDA, sponsors usually front-load as much work as is possible at risk. The approach is inefficient if the trial fails as the sponsor is unlikely to proceed with the plan that assumed success. This note addresses how to improve the operational efficiency and reduce the risk of work done upfront by letting an independent entity provide the sponsor highly limited but necessary information at an earlier time.