Feasibility estimation for clinical trials

Abstract

At least 90% of trials are extended by at least 6 weeks because investigators fail to enroll patients on schedule. It is therefore important at trial design-time to have good insight in how the choice of the eligibility criteria affects the recruitment rate. Based on that insight, trial designers can then adjust the eligibility criteria in order to ensure realistic recruiting rates. In this paper we propose a simple mathematical model to determine how eligibility criteria determine the recruitment rate. We have implemented this mathematical model in efficient algorithms, and we demonstrate our model on both real and synthetic patient data. Our experiments show that almost all medical trials in our test corpus contain superfluous criteria, and that this redundancy can only be revealed with our new relative feasibility measure (and not with the classical absolute feasibility measure). To increase the reproducibility of our results, we have made our datasets available online.