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The coming paradigm shift in clinical research
- 1. The Coming Paradigm Shift in Clinical Research David R Munoz, MD, MPH, FACP, CMD June 21, 2013 After this presentation you should be able to: Explain why there will be a major shift in clinical research Explain how the publication process is being rerouted Understand the implications of leveraged information Explain how Analytics approaches the problems Understand the common statistical processes
- 2. Uncertainty
- 3. The old “eye ball test” • What odd’s do you want to take boarding an airplane? • Six Sigma results in 1 fatal commercial flight in 3.6 million • Current hospital practice results in 5% mortality or worse… Keep a sharp eye
- 4. The fabled coin toss
- 5. Why do we like dichotomous variables? • True or False, Black or White, Ying or Yang. • A dichotomy is any splitting of a whole into exactly two non-overlapping parts, meaning it is a procedure in which a whole is divided into two parts. It is a partition of a whole (or a set) into two parts (subsets) that are: • jointly exhaustive: everything must belong to one part or the other, and • mutually exclusive: nothing can belong simultaneously to both parts. • Such a partition is also frequently called a bipartition. • The two parts thus formed are complements. In logic, the partitions are opposites if there exists a proposition such that it holds over one and not the other. Simplicity
- 6. Risk • The remarkable tale of risk, is mankind’s epic battle against the gods. Luca Paccioli, born in about 1445, was a Franciscan monk who published his masterwork, Summa de arithmetic, geometria et proportionalita in 1494. Among other notable derivatives this popularized (but did not invent) double entry bookkeeping. Lucca Paccioli
- 7. Life is Good • Giralamo Cardano 16th century physician (1500-1571) published his autobiography De Vita Propria Liber in which he detailed his addiction to games of vice and chance. More importantly for our sake, he also published Ars Magna in 1545 just 5 years after the appearance of “+” and “-“. He also published Liber de Ludo Alea (Book on Games of Chance). Throughout these works Cardano was laying out calculations of probability. Giralamo Cardano
- 8. Uncertainty • Rarely however is there true certainty. There a fundamental limit to the precision with which certain pairs of physical properties can be known simultaneously. For instance, the more precisely the position of some particle is determined, the less precisely its momentum can be known, and vice versa.[1] The original heuristic argument that such a limit should exist was given by Werner Heisenberg in 1927, after whom it is sometimes named the Heisenberg principle. Werner Heisenberg
- 9. Precision How good is your aim?
- 10. No longer analog, data is now digital • Data is being driven by the digitalization of information think of what has happened with color
- 11. 36 PATIENTS WITH 843 ADMITS High utilizations across 3.5 years 17 Women 19 Men
- 12. Sepsis 2012
- 14. E-prescribing • The digitalization of patient prescriptions will unleash a major paradigm shift • This will also dramatically shift the current role of Pharma in Clinical Research • We will be able to correlate sentinel events, e.g. death, admission, procedures such as cardiac catheterization and surgical procedures
- 15. Digitalized data is manipulatable
- 16. Here is summary data for 2 years
- 18. Analog to Digital The transition of clinical research • The past … • Published 2013 • Accepted 2012 • Submitted 2011 • Data set 2007-09 • Outdated by the time you see it • The future • Published electronically this morning • Peer reviewed last week • Completed last month • Data set through last quarter • Here now and usable