Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application

Trials. 2016 Jul 22;17(1):336. doi: 10.1186/s13063-016-1457-3.

Abstract

Background: Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. The previously developed Bayesian method integrates researchers' experience on former trials and data from an ongoing study, providing a reliable prediction of accrual rate for clinical studies.

Methods: In this paper, we present a user-friendly graphical user interface program developed in R. A closed-form solution for the total subjects that can be recruited within a fixed time is derived. We also present a built-in Android system using Java for web browsers and mobile devices.

Results: Using the accrual software, we re-evaluated the Veteran Affairs Cooperative Studies Program 558- ROBOTICS study. The application of the software in monitoring and management of recruitment is illustrated for different stages of the trial.

Conclusions: This developed accrual software provides a more convenient platform for estimation and prediction of the accrual process.

Keywords: Bayesian methods; Smartphone application; Statistical software; Subject accrual.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Bayes Theorem
  • Computer Graphics
  • Data Interpretation, Statistical
  • Humans
  • Mobile Applications*
  • Models, Statistical*
  • Multicenter Studies as Topic / methods
  • Multicenter Studies as Topic / statistics & numerical data*
  • Patient Selection*
  • Randomized Controlled Trials as Topic / methods
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Robotics
  • Sample Size*
  • Smartphone*
  • Stroke / diagnosis
  • Stroke / physiopathology
  • Stroke / therapy
  • Stroke Rehabilitation / methods
  • Time Factors
  • User-Computer Interface