Mike O'Fallon speaks at Center for Applied Mathematics colloquium Dec. 1
The CAM colloquium series, sponsored by the Center for Applied Mathematics, is intended to introduce the University of St. Thomas community to a variety of problems, careers and professional activities involving applications of mathematics.
Mike O'Fallon from the Mayo Clinic will speak on "Methodological Issues Encountered in the Review of the TPA Trials: A Statistical and Neurological Odyssey," at 3 p.m. Friday, Dec. 1, in 3M Auditorium, Room 150, Owens Science Hall, located at the southwest corner of Summit and Cretin avenues in St. Paul. Refreshments will be available at 2:45 p.m.
"For a health actuary, the single biggest uncertainty in pricing is the rate of increase in medical costs, otherwise known as trend.
"In 1996, on the basis of two NIH sponsored randomized clinical trials, the FDA approved IV t-PA as therapy for acute ischemic stroke; however, physicians' reluctance to accept the complicated therapy and subsequent disclosure that the stroke severity distributions in the two treatment arms differed significantly, kept the rate of use of t-PA low.
"This, along with an increasing volume of letters, editorials, manuscripts and BLOGS critical of the treatment, the studies, and the individuals and institutions involved, prompted the NIH to commission a committee of independent investigators to review the protocols and consider the criticisms. Whether the imbalance in stroke severity invalidated the study results, as charged by some, was to be a primary focus.
"The committee began work in June 2002, issued a comprehensive report in August 2003 and published a manuscript in August 2004. We will discuss the policy issues encountered and the logistical, data management and statistical methods used by the committee to arrive at its conclusion that, despite the recognized imbalance and other issues, the results reported by the NINDS investigators were valid."