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Application of stochastic processes to participant recruitment in clinical trials
1Department of Biometry and Epidemiology, Medical University of South Carolina, 135 Cannon Street, Ste 303, P.O. Box 250835, Charleston, SC 29425, USA. carterre@musc.edu
Abstract:
The allocation of sufficient time for participant recruitment is one of the fundamental aspects in planning a clinical trial. This paper illustrates how a Poisson process can be used to determine an optimal period of time for participant recruitment by simulating Poisson arrival into a clinical trial. The simulation study provides the means to generate of an empirical probability density function for the recruitment time based on time-dependent changes in the accrual rate. From this empirical distribution, a clinical trial recruitment period can be planned to provide a high level of confidence (e.g., 90% probability) of enrolling the sample size within the planned amount of time given the simulation assumptions.
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