Department of Biostatistics Seminar/Workshop Series
MORBIDITY AND METHODOLOGY CONFERENCE :
Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis
Gordon Bernard, MD, Professor of Medicine, Vanderbilt University
Frank Harrell, PhD, Professor of Biostatistics, Vanderbilt University
Wednesday, March 10, 1:30-2:30pm, MRBIII Conference Room 1220
Persons interested in research methodology (especially for clinical trials), biostatistics, Vanderbilt research resources, critical care medicine, sepsis.
This is the first in the Department of Biostatistics and Vanderbilt Institute for Clinical and Translational Research's series in which we present a paper published by a Vanderbilt investigator and provide a methodologic dissection of the paper with an eye on finding opportunities for improved design or analysis as well as identifying VICTR and other resources that would have benefitted the research. An author of the paper will present key elements of the paper and discuss challenges in its publishing (e.g., space limitations preventing a full description of what was done), and a methodologist will discuss the methodology employed.
In this presentation, Dr Bernard will present the design and key results and challenges from his important paper from which came the title for this conference (NEJM 344:699; 2001). This was a landmark paper in the treatment of severe sepsis although the medical community has yet to fully adopt the efficacious treatment. Dr Harrell will discuss whether recent enhancements in clinical trial design and analysis could improve on the paper, as well as whether there are any statistical pitfalls.