Bayesian stopping guidelines for heart valve premarket approval studies Gary L. Grunkemeier, PhD, YingXing Wu, MD, MS, Lian Wang, MS, Cody Hamilton, PhD

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Presentation transcript:

Bayesian stopping guidelines for heart valve premarket approval studies Gary L. Grunkemeier, PhD, YingXing Wu, MD, MS, Lian Wang, MS, Cody Hamilton, PhD The Journal of Thoracic and Cardiovascular Surgery Volume 148, Issue 6, Pages 2813-2817.e1 (December 2014) DOI: 10.1016/j.jtcvs.2014.06.085 Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 A, Point estimates and 90% two-sided confidence intervals for the TE rate at the end of the study, for various values of E2 occurring after the current data review, where E1 = 11 events have been observed in the first 400 (T1) patient-years. The upper confidence limit is the same as a one-sided 95% limit, so cases with an upper limit less than 2 × OPC (= 5%) will pass the OPC test. B, Cumulative distribution of the predictive probabilities for the number E2 of future TEs. TE, Thromboembolism; CI, confidence interval; OPC, objective performance criteria. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 A, Point estimates and 90% two-sided confidence intervals for the TE rate at the end of the study, for various values of E2 occurring after the current data review, where 19 events have been observed in the first 400 patient-years. The upper confidence limit is the same as a one-sided 95% limit, so cases with an upper limit less than 2 × OPC (= 5%) will pass the OPC test. B, Cumulative distribution of the predictive probabilities for the number E2 of future TEs. TE, Thromboembolism; CI, confidence interval; OPC, objective performance criteria. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 Predicted probabilities of passing the OPC test at the end of the trial for a complication with an OPC of 2.5%/y (TE for biological valves), computed for various numbers of events (E1) observed at various intermediate data review times (T1). The 2 examples depicted in Figures 1 and 2, after 400 patient-years were observed, are shown by the slightly larger circles at the top and bottom of the 400 patient-years grouping, with the corresponding digits (1, 2) superimposed. Symbols below the red horizontal gridline at 10% indicate performance that may influence the Data Monitoring Committee members to consider stopping the trial. These probabilities were derived using a noninformative (Jeffreys) prior distribution. OPC, Objective performance criteria. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 4 Predicted probability of success at the end of the trial for a complication with an OPC of 1.2%/y (endocarditis and leak for biological valves), computed for various numbers of events observed at various intermediate data review times. Symbols below the red horizontal gridline at 10% indicate performance that may influence the Data Monitoring Committee members to consider stopping the trial. These probabilities were derived using a noninformative (Jeffreys) prior distribution. OPC, Objective performance criteria. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 A reproduction of Figure 3, but with a mildly informative prior distribution, based on the OPC value. OPC, Objective performance criteria. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions

Figure 6 Comparison of 2 different estimates of the probabilities of the numbers of future events: (1) the naive Poisson distribution, based on a fixed value of λ; (2) the negative binomial distribution, which takes into account the imprecision in the estimate of λ, and thus has more variability. The Journal of Thoracic and Cardiovascular Surgery 2014 148, 2813-2817.e1DOI: (10.1016/j.jtcvs.2014.06.085) Copyright © 2014 The American Association for Thoracic Surgery Terms and Conditions