Speaker
Lisa Wruck, PhD
Pragmatic clinical trials (PCTs) are increasingly used to generate timely, practice relevant evidence, but their real world orientation introduces distinct statistical challenges. This seminar provides a practically focused overview of statistical considerations in the design and analysis of pragmatic clinical trials, emphasizing how key choices affect validity, interpretability, and decision making.
We will frame pragmatic trials as a continuum rather than a binary alternative to explanatory randomized controlled trials, using PRECIS 2 as a conceptual scaffold. High impact design decisions-such as eligibility criteria, outcome selection, randomization unit, use of real world data, and blinding limitations-will be discussed alongside their downstream analytic implications. Analysis topics will include estimands, analysis populations, missing data, heterogeneity of treatment effects, and handling intercurrent events, with an emphasis on pre-specification and alignment between design and analysis.
Illustrative examples from large pragmatic trials will be used to make these concepts concrete.
Zoom link: https://duke.zoom.us/j/96158350382
This event is being cross-promoted by the NC BERD Consortium, a collaboration of the CTSA-funded BERD cores at UNC-Chapel Hill, Wake Forest University School of Medicine, and Duke University School of Medicine.