The Clinical Utility Index, a Method for Balancing Efficacy and Safety ...

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CUI picks up where biostat./PM currently leave off… While biostat./PM provide methods to quantify the levels of knowledge and uncertainty surrounding drug attributes, the CUI provides a quantitative model describing the preferences for tradeoffs between competing attributes. It is both a tool and a process; many project teams have reported great benefits for simply ―going through the CUI process.‖ • A CUI cannot make a bad drug good, although it can help project teams to realize that it‘s bad. • Likewise, it cannot change the amount of uncertainty that exists, but it can help to remove ambiguity, resulting in a clear statement of how much uncertainty there is and how to manage it. The CUI process can be extended to model market share and linked to traditional pharmaceutical decision analysis (i.e., ―NPV‖), if desired. Slide 28 © Tripos, L.P. All Rights Reserved
Putting CUI into Practice A relatively new application of a well-tested process Implementation is often a joint effort (decision analysis, pharmacometrics, and biostatistics) The math is simple, but proper use requires careful education in the process and underlying assumptions (as with any of our tools) In conclusion, CUI is an important new and broadly applicable tool that will help to elevate the work of this audience by more directly linking it to the decisionmaking process at all levels. Slide 29 © Tripos, L.P. All Rights Reserved
Page 1 and 2: The Clinical Utility Index, a Metho
Page 3 and 4: MOTIVATION Slide 3 © Tripos, L.P.
Page 5 and 6: Motivation - Each drug has a list o
Page 7 and 8: Motivation - ―What is so?‖ vers
Page 9 and 10: INTRODUCTION TO THE CUI Slide 9 ©
Page 11 and 12: Utility The Clinical Utility Index
Page 13 and 14: The underpinnings of CUI are severa
Page 15 and 16: The CUI is an additive multivariate
Page 17 and 18: Construction of a CUI function take
Page 19 and 20: Construction of a CUI function take
Page 21 and 22: CASE STUDY Slide 21 © Tripos, L.P.
Page 23 and 24: SES (cfb) SES (cfb) We explored the
Page 25 and 26: CUI allowed us to link our pharmaco
Page 27: The Clinical Utility Index reduces
Page 31 and 32: BACKUP Slide 31 © Tripos, L.P. All
Page 33: Extensions of CUI Slide 33 © Tripo

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