Bayesian modeling and prediction of accrual in multi-regional clinical trials.

Abstract:

:In multi-regional trials, the underlying overall and region-specific accrual rates often do not hold constant over time and different regions could have different start-up times, which combined with initial jump in accrual within each region often leads to a discontinuous overall accrual rate, and these issues associated with multi-regional trials have not been adequately investigated. In this paper, we clarify the implication of the multi-regional nature on modeling and prediction of accrual in clinical trials and investigate a Bayesian approach for accrual modeling and prediction, which models region-specific accrual using a nonhomogeneous Poisson process and allows the underlying Poisson rate in each region to vary over time. The proposed approach can accommodate staggered start-up times and different initial accrual rates across regions/centers. Our numerical studies show that the proposed method improves accuracy and precision of accrual prediction compared to existing methods including the nonhomogeneous Poisson process model that does not model region-specific accrual.

journal_name

Stat Methods Med Res

authors

Deng Y,Zhang X,Long Q

doi

10.1177/0962280214557581

subject

Has Abstract

pub_date

2017-04-01 00:00:00

pages

752-765

issue

2

eissn

0962-2802

issn

1477-0334

pii

0962280214557581

journal_volume

26

pub_type

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