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Activity Number: 262
Type: Contributed
Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract #318555
Title: Risk-Based Monitoring Rules for Binomial and Poisson Outcomes in Clinical Trials with Software Implementation in JMP
Author(s): Anastasia Dmitrienko* and Richard C. Zink
Companies: and JMP Life Sciences, SAS Institute
Keywords: Risk-based monitoring ; Clinical trials ; Control limits ; JMP Software ; Adverse events

Risk-based monitoring (RBM) strategies have been broadly applied in clinical trials to detect sites with unusual characteristics. Monitoring rules may be defined using clinically-based criteria, such as the risk thresholds suggested by TransCelerate Biopharma. Alternatively, monitoring rules may utilize control limits that define an expected amount of variability for the outcome of interest. This poster focuses on developing control limits for binomial and Poisson outcomes. The control limits are based on asymptotic and exact confidence intervals for the corresponding parameters. Factors that affect the expected amount of variability such as patient's time on study are considered when computing the control limits. The methods developed in this poster are applied to define rules for monitoring binary outcomes such as patient discontinuation and count outcomes such as the number of adverse events per patient in several real clinical trials. RBM rules for binomial and Poisson outcomes are conveniently summarized using funnel plots with asymptotic and exact control limits defined using the methods described above. These RBM strategies are implemented using JMP software.

Authors who are presenting talks have a * after their name.

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