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Title Ethics of Biostatistics in Clinical Translational Research
Year 2011
Contributor/Contact BradPollock
Success Topic Manuscripts
Description of Success Jonathan Gelfond M.D., Ph.D., an assistant professor of biostatistics, received one of first three KL2 awards from the University of Texas Health Science Center’s (UTHSCSA) Institute for the Integration of Medicine and Science (home of our CTSA). As part of the ethics component of the CTSA KL2 training program, Dr. Gelfond presented a discussion on ethical challenges in biostatistics. With prominent recent examples of specious results and classic texts such as “How to lie with statistics,” it is apparent that the ethics of data analyses are constantly under justifiable scrutiny. Less broadly appreciated is the great effort of professional statisticians provide to ensure that objective results are obtained from clinical and translation studies. Frustratingly, salient infractions cast a pejorative shadow that envelops the practice of statistics and fosters cynical skepticism. Distinctions between negligent and excellent analyses are obfuscated and can be lost. Meanwhile, the contemporary statistical challenges of high-throughput analyses and the translational research enterprise have made the stakes of data analyses higher than ever.

The experience of teaching translational biostatistics to clinicians led to the conclusion that the critical elements of statistical practice can easily missed when statistics is presented as an armada of ever more complex methodologies. Our challenge was to effectively communicate the key ethical principles to a multidisciplinary audience within a brief seminar. One of our inspirations was the work of Atul Gawande, M.D. who conceived a compact surgical checklist that was shown to prevent lapses and improve surgical outcomes. This checklist demonstrated that the careful consideration of well-known principles can be remarkably effective. We strived to create similar checklist of nontechnical, but powerful principles that would distinguish between high-quality ethical analyses and poor quality/questionable research. UTHSCSA CTSA ethicist Craig Klugman Ph.D. was the expert discussant in the seminar and encouraged Dr. Gelfond write an article based upon these ideas. They formed a research team with his KL2 mentor Brad Pollock, M.P.H., Ph.D. Biostatistics, Epidemiology, Research Design (BERD) Core Director at UTHSCSA, and ethicist Elizabeth Heitman, Ph.D. (Vanderbilt CTSA). This interdisciplinary and inter-institutional collaboration resulted in the ten principles described in the publication: Gelfond JAL, Heitman E, Pollock BH, Klugman CM: Principles for the Ethical Analysis of Clinical and Translational Research. Statistics in Medicine 2011, 30(23):2785–2792.
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Topic revision: r1 - 17 Jan 2012 - 14:22:33 - MaryBanach

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