Jeff A. Sloan, Ph.D. Mayo Clinic, Rochester, MN, USA. Clinical Significance for Quality of Life Endpoints in Clinical Trials. FDA/Industry Statistics Workshop Washington, September 16, 2005. Primary goal: advance the state of the science to help cancer patient QOL soar.
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Jeff A. Sloan, Ph.D.
Mayo Clinic, Rochester, MN, USA
Clinical Significance for Quality of Life Endpoints in Clinical Trials
FDA/Industry Statistics Workshop
Washington, September 16, 2005
Primary goal: advance the state of the science to help cancer patient QOL soar
It takes a certain amount of bravery to work in QOL research
Science is a candle in the dark
- Carl Sagan
We will use the candle of science to improve the QOL of cancer patients
How do you determine
the clinical significance
of QOL assessments?
What is a clinically meaningful QOL burden?
No single statistical decision rule or procedure can take the place of well-reasoned consideration of all aspects of the data by a group of concerned, competent, and experienced persons with a wide range of scientific backgrounds and points of view.
If it looks like a duck, sounds like a duck, and walks like a duck, the odds of it being a worm or an elephant in a clever disguise are small in the extreme.
(Sloan, J Chronic Obs. Pul. Dis. 2: 57-62, 2005.)
Presenting global solutions is always interesting
The MID method in one slide
= 16.7% of theoretical range
small, moderate, large effect(0.2, 0.5, 0.8 SD shift)
Norman GR, Sloan JA, Wyrwich KW. Expert Review of Pharmacoeconomics and Outcomes Research Sept 2004; 4(5): 515 – 519
Sloan JA, Cella D, Hays R. J Clin Epidemiol (in press).
New ideas have enabled us to make advances in QOL science