Communications for Statistical Applications and Methods

The Korean Statistical Society (한국통계학회)
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Sequential patient recruitment monitoring in multi-center clinical trials

  • Kim, Dong-Yun (National Heart, Lung and Blood Institute / National Institutes of Health) ;
  • Han, Sung-Min (Open Source Electronic Health Record Alliance (OSEHRA)) ;
  • Youngblood, Marston Jr. (The University of North Carolina at Chapel Hill)
  • Received : 2018.03.02
  • Accepted : 2018.08.17
  • Published : 2018.09.30
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Abstract

We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.

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References

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