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Conference on Statistical Issues in Clinical Trials: From Bench to Bedside to Community. Bryan R. Luce, Ph.D., MBA University of Pennsylvania April 27, 2010. To Meet the CER Challenge We Need Inspirational & Transformational Change. Investment (Private & Public) Policy Research Methods
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Bryan R. Luce, Ph.D., MBA
University of Pennsylvania
April 27, 2010
Investment (Private & Public)
Thresholds for Decision-Making
Example in Trial Methods for CER
and can be…
*Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack
**Clin Antipsychotic Trials of Intervention Effectiveness
Neither trial concluded in favor of the sponsor’s product.
*** Pravastatin or Atorvastatin Evaluation & Infection Therapy–Thrombolysis in MI
****Effect of Combination Ezetimibe & High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia
*Tunis, Strayer, Clancy, JAMA 2003
and highly likely to see…
CER trials are unsustainable without transformational change in design to generate useful evidence more efficiently
IOM EBM Roundtable “Learning Health Care System” concept
….all of these are
…essentially, Bayesian and/or adaptive concepts dealing with Bayesian expressed problems.
I would argue that thresholds relative to tolerance of uncertainty varies by the decision and the decision maker
“If we go to war with the Soviet Union, I would want
General LeMay in the lead plane….
whether to go.”
President John F. Kennedy, circa 1962
I would want the statistician to design and analyze it…
(or probability) threshold as to accepting it.
More important than increasing precision, reducing bias in study design (although admittedly both are important) is
With respect to the primacy of effectiveness over efficacy…
“…an imprecise estimate of the right concept is superior to a precise estimate of a wrong concept”
And in 1988, Read put it another way…
Read goes on to graphically depict his notion of accuracy being superior to precision.
Source: Reed JL. From Medical to Socioeconomic Evaluation of Drug Therapy. p.79. In: van Eimeren W, Horisberger B (eds). Socioeconomic Evaluation of Drug Therapy. Springer-Verlag, Berlin: 1988.