Randomized Trials (RT) and Accelerated approval (AA) More patients and time Allows AA at any disease stage (surrogate beats available therapy) Allows add-on design (A vs A + B) Allows a variety of endpoints –Time to event (TTP, survival) –Endpoints requiring blinding (symptoms, QOL) Defines individual drug contribution –(oxaliplatin vs 5FU/LCV versus oxaliplatin + 5FU/LCV)
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