A Machine Learning Approach for Predicting Clinical Trial Patient Enrollment in Drug Development Portfolio Demand Planning

One of the biggest challenges the clinical research industry currently faces is the accurate forecasting of patient enrollment (namely if and when a clinical trial will achieve full enrollment), as the stochastic behavior of enrollment can significantly contribute to delays in the development of new drugs, increases in duration and costs of clinical trials, and the over- or under- estimation of clinical supply. This study proposes a Machine Learning model using a Fully Convolutional Network (FCN) that is trained on a dataset of 100,000 patient enrollment data points including patient age, patient gender, patient disease, investigational product, study phase, blinded vs. unblinded, sponsor CRO selection, enrollment quarter, and enrollment country values to predict patient enrollment characteristics in clinical trials. The model was tested using a dataset consisting of 5,000 data points and yielded a high level of accuracy. This development in patient enrollment prediction will optimize portfolio demand planning and help avoid costs associated with inaccurate patient enrollment forecasting