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.