Keywords: Clinical Trial Prediction, Ctrough, Deep Learning, Recurrent Neural Network
Predicting Phase 3 clinical trial results is a critical step of Go/No-Go decision making and Phase 3 trial design optimization. To predict the overall treatment effect for patients enrolled into a Phase 3 trial, we propose a framework consisting of two models. First, an individual trough pharmacokinetic concentration (Ctrough) model is developed to predict the trough pharmacokinetic concentration for a potentially new treatment regime planned for Phase 3. Second, an individual treatment effect model is built to model the relationship between patient baseline characteristics, Ctrough and clinical outcomes. These two models are combined together to predict Phase 3 clinical trial results. Since the clinical outcomes to be predicted are longitudinal and the predictors are a mix of time-invariant and time-variant variables, a novel neural network, Residual Semi-Recurrent Neural Network, is developed for both models. The proposed framework is applied in a post-hoc prediction of Phase 3 clinical trial results, and it outperforms the traditional method.