The Coming Paradigm Shift in Clinical Research

David R Munoz, MD, MPH, FACP, CMDJune 21, 2013

After this presentation you should be able to:

Explain why there will be a major shift in clinical researchExplain how the publication process is being reroutedUnderstand the implications of leveraged information

Explain how Analytics approaches the problemsUnderstand the common statistical processes

Uncertainty

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

The fabled coin toss

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

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

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

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

Precision

How good is your aim?

No longer analog, data is now digital

• Data is being driven by the digitalization of information think of what has happened with color

36 PATIENTS WITH 843 ADMITS

High utilizations across 3.5 years

17 Women19 Men

Sepsis 2012

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

Digitalized data is manipulatable

Here is summary data for 2 years

Desk top publishing

Analog to DigitalThe 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