Use of phase 2 interim analysis to expedite drug development decisions
*Qi Xia, Genentech Keywords: Ph2 interim analysis, Ph3 Go/No Go, decision making A randomized Ph2 oncology trial with porgression free survival (PFS) as primary endpoint typically takes around 2 years to gather enough data for a relatively robust Go/No Go decision making to Ph3. In order to expedite the drug development timeline and reduce the development cost, we proposed a consistent decision-making strategy to enable earlier development decisions without complicating the trial design and compromising the sponsor’s ability to identify gaps in knowledge and thoughtfully design the phase 3 trial. We will first examine the theoretical basis and empirical evidence from Roche/Genentech oncology trials for using the phase 2 interim analysis to facilitate earlier development decisions that is consistent with the final phase 2 readout. The predictive probability method will be applied to determine the early decision criteria incorporating different levels of historical knowledge into the prior distribution. The false Go/No Go risks associated with the early decision will be characterized. Lastly we will address issues related to the benefit, cost and implementation details when the strategy is being applied to trials in real world from Roche/Genentech experience.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC