An Evaluation of Confidence Intervals for a Cumulative Proportion to Enable Decisions at Interim Reviews of Single Arm Clinical Trials

HARVARD T.H. CHAN DEPARTMENT OF BIOSTATISTICS PRESENTS:

SPEAKER: Dr. Linda Harrison, PhD Research Scientist, Harvard TH Chan School of Public Health, Department of Biostatistics, (CBAR)

ABSTRACT: Clinical trials often include interim analyses of the proportion of participants experiencing an event by a fixed time point. Frequently this cumulative proportion is estimated by the Kaplan-Meier estimator with a Wald approximate CI, which may have coverage issues with small samples or high event proportions. We reviewed four alternative CI methods for cumulative proportions (Beta Product Confidence Procedure (BPCP), BPCP Mid P, Rothman-Wilson, Thomas-Grunkemeier) and two CI methods for simple proportions (Clopper-Pearson, Wilson score). We conducted a simulation study comparing the CI methods and re-analyzed interim data from a HIVtrial considering the proportion of participants experiencing virologic failure.

HYBRID SESSION:

IN-PERSON LOCATION: Room: 2-426 (conference room)

VIRTUALLY: Zoom ( https://harvard.zoom.us/j/96292345146?pwd=MHFna0RSMjI2QlJHdHVoeUQ2aEpJUT09)

Remaining Schedule through December 2023:

  • November 17, 2023 (Muhammed Semakula)
  • December 1, 2023 (Keith Barnatchez)

Contact Daniel Xu danielxu@hsph.harvard.edu or Keith Barnatchez keithbarnatchez@g.harvard.edu for questions.