A Simulation framework for expanding eligibility criteria in clinical trials

Megan O’Sullivan, Queen’s University Belfast

Co-authors: Adele Marshall, Queen’s University Belfast; Judy Bradley, Queen’s University Belfast; Aiden Flynn, Exploristics

Abstract: The strict eligibility criteria for clinical trials leads to difficulties meeting recruitment targets and a lack of information on how a new drug will affect the general patient population. This paper proposes a model that simulates clinical trials for bronchiectasis. The aim of the model is to identify patients who previously have not met eligibility criteria who could be introduced into the pool of patients for recruitment. A major reason for the exclusion of these patients is the possibility that these patients will not be as responsive to treatment. The proposed model simulates trials for combinations of sample size and proportion of the trial population made up of previously ineligible patients. The results of these simulations can be used to examine the impact of including these patients on both statistical power and generalisability of results.