ATLCEP: A New Integrated Design that Encompasses the Safety and Efficacy Objectives of Phase I/II Trials
ATLCEP: A New Integrated Design that Encompasses the Safety and Efficacy Objectives of Phase I/II Trials
Several designs, such as designs to find the optimal biological dose, the Eff-Tox design and seamless Phase I/II designs, have been proposed to evaluate both drug toxicity and efficacy as alternatives to the traditional paradigm of a stepwise drug development approach. Here, we first examine the effect of sample and …