Interim recruitment prediction for multi-centre clinical trials

Urbas, Szymon and Sherlock, Christopher (2022) Interim recruitment prediction for multi-centre clinical trials. Biostatistics, 23 (2). pp. 485-506. ISSN 1465-4644

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Abstract

We introduce a general framework for monitoring, modeling, and predicting the recruitment to multi-center clinical trials. The work is motivated by overly optimistic and narrow prediction intervals produced by existing time-homogeneous recruitment models for multi-center recruitment. We first present two tests for detection of decay in recruitment rates, together with a power study. We then introduce a model based on the inhomogeneous Poisson process with monotonically decaying intensity, motivated by recruitment trends observed in oncology trials. The general form of the model permits adaptation to any parametric curve-shape. A general method for constructing sensible parameter priors is provided and Bayesian model averaging is used for making predictions which account for the uncertainty in both the parameters and the model. The validity of the method and its robustness to misspecification are tested using simulated datasets. The new methodology is then applied to oncology trial data, where we make interim accrual predictions, comparing them to those obtained by existing methods, and indicate where unexpected changes in the accrual pattern occur.

Item Type:
Journal Article
Journal or Publication Title:
Biostatistics
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/2600/2613
Subjects:
?? statistics and probabilitystatistics, probability and uncertaintygeneral medicinemedicine(all) ??
ID Code:
146716
Deposited By:
Deposited On:
21 Aug 2020 11:25
Refereed?:
Yes
Published?:
Published
Last Modified:
16 Jul 2024 11:30