Multi-Center Clinical Trials with Random Enrollment: Theoretical Approximations.

FEDOROV, VALERII; JONES, BYRON; MATTHEW JONES, C.; ZHIGLJAVSKY, ANATOLY

We consider the problem of analyzing multi-center clinical trials when the number of patients at each center and on each treatment arm is random and follows the Poisson distribution. Theoretical approximations are made for the first two moments of the mean square errors (MSE's) for three different estimators of treatment effect difference that are commonly used in multi-center clinical trials. To construct these approximations, approximations are needed for the harmonic mean and negative moments of the Poisson distribution. This is achieved through the use of recurrence relations. The accuracy of the approximations for the moments of the MSE's were then validated through comparing the theoretical values to those obtained from a simulation study under two different enrollment environments.

CLINICAL trials; POISSON distribution; DISTRIBUTION (Probability theory); CHARACTERISTIC functions; PROBABILITY theory; CLINICAL medicine research

Communications in Statistics: Theory & Methods, 2005, Vol 34, Issue 4, p955

0361-0926

Academic Journal

10.1081/STA-200054422