Graphics Graphics

Graphics, Graphics Everywhere and
Not a Plot to Print!
An overview of the current graphics landscape within Novartis Pharma
Development
Phuse Single Day Event, June 2012
Stephen Hart, Ulrich Knappich
The opinions expressed in this presentation and on the following slides
are solely those of the presenter and not necessarily those of Novartis.
Novartis does not guarantee the accuracy or reliability of the information
provided herein
Background
§  The general use and quality of interactive graphical interfaces is
ever increasing with new technologies and software e.g. smart
phones, tablets, etc.
§  Within Novartis Pharma development new technologies are
consistently enhancing the way we work e.g. integration of iPad’s
for field monitors
§  Within high caliber scientific publications the amount and quality of
graphics seems to be high e.g. Lancet
§  Yet high quality graphics continue to form an important but only
minor part of dossiers submitted to pharmaceutical regulators
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Introduction
§  We are currently analysing the technologies available in Novartis to
create our clinical graphics. This is with a view to:
Ø  Increasing the number of graphics being produced for all types
of analysis and reporting activities
Ø  Rationalizing the products we use
Ø  Establishing a strategy for which products to use when
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Introduction
This presentation briefly explores:
§  Novartis and external landscapes
§  The pros and cons of the products we at Novartis currently use
§  A potential change in the way we may produce and view production
of graphics within our environment
Ø  Focus on two technologies recently added to our portfolio:
Ø  SAS V9.3 ODS Graphics Designer and Tibco Spotfire Clinical
Graphics (TSCG).
§  This is not a sales pitch for any product mentioned!!!!
4 | <Scope-Seek/Planning/Execution> | Project Charter | Project Name | Author | Date | Business Use Only
Why Do We Need Graphics?
§  Question: What have the following items have in common?
Ø  News report comparing government finances in the Eurozone
Ø  TV ad for a new toothpaste
Ø  Self assembly flat-pack cupboard
§  Answer: They would typically all be presented with an illustration,
picture or graphic
§  Showing a graphic is an easy way to present information in a quick
and clear manner
§  In our industry, increased use of graphics could cut down on
internal and external review time, getting drugs to market more
quickly J
“A Picture Paints a Thousand Words”
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Why Do The Dossiers We Submit Contain So Few Graphs?
§  Clinical data is bulky and complex, not always easy see
relationships. So why do we in the pharmaceutical industry not
utilize graphics more?
Ø  Not a formal regulatory requirement?
Ø  Graphics only needed for presentations and publications?
Ø  Not enough ”Bang for our Bucks”? Investment in time and
money to build/develop an efficient graph application too large?
Ø  Producing a graph is regarded as a resource intensive activity?
Ø  Easier to display the numbers (tables produced anyway)?
Ø  Lack of time to stop and think of new and better ways to display
data? Other priority work to attend to?
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Why Do The Dossiers We Submit Contain So Few Graphs?
Ø  When testing ideas, no software tools available to visualize the
data presented in different graphical formats.
Ø  Difficult to determine which graph type better displays certain
data e.g. continuous, categorical, nominal, ordinal, distribution
of variable
Ø  Are we always able to keep up with the pace of change? Do we
really know what’s around and possible?
Ø  Or do we just follow the previous set of reports that were
produced for a similar activity?
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Evolution of the Application Landscape
§  Did we always have many tools that could easily create high quality
graphics efficiently? Do we have these today?
§  The first version of SAS which I used in 1999 was SAS 6.12
§  Graphics production using SAS was technically challenging!
§  The technology didn’t allow crisp high quality graphics we see
today. Device drivers and multiple software were not compatible.
Multiple Operating systems needed to get final product e.g. Unix,
Linux, Windows, etc.
§  How could we ensure that this process was reproducible and
auditable in line with external regulation?
§  Many other graphics solutions have become available
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Evolution of the Application Landscape
§  Are we now at a point in time where we can look at producing high
quality graphics more quickly and easily?
Ø  Prepared templates, and code generators mean time to develop
a graph can be reduced.
Ø  Solutions integrated into our landscape allow reproducibility and
auditability of graph programming.
Ø  Code sharing or prototypes of code that do 80-90% of the job e.g.
CTSPedia, mean that a wide range of graphics can be produced
in a reduced time.
9 | <Scope-Seek/Planning/Execution> | Project Charter | Project Name | Author | Date | Business Use Only
Analysis of Current Novartis Landscape
§  My experience covers both “End-user”, “SAS Developer” and IT
business analyst roles
§  I have seen and viewed the landscape from a few angles
§  After thinking about the amount number of graphics tools we
currently have available to us many questions came to me:
Ø  What tool should be used for what purpose?
Ø  How does a user know which tool should be used when?
Ø  How long does it take to create a report for each tool?
Ø  Which tools are used by which groups?
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Analysis of Current Novartis Landscape
§  Recently I had the opportunity to see a demo from SAS on “High
performance analytics”
Ø  SAS visual analytics applications used mainly for marketing,
forecasting and commercial purposes
Ø  Exceptional amount of “Big Data” being crunched and displayed very
quickly
Ø  One billion observations analyzed and displayed in minutes
§  We need to modify our approach to use these technologies
Ø  Difficult to use “out-of-the-box” tools in our regulated environment
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Reports, Paper, Action! / 88 numbers but what's the
story....
§  This small snapshot of
the first page of a
typical set of summary
information –it
contains 88 numbers
§  In large outcome trials
a single AE incidence
table may cover more
than 100 pages
§  But what does it tell
us?
§  Is it really possible to
review this
information in its
fullest form?
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13
14
Application Vrs Characteristics Matrix (Novartis)
Characteristics
Application JMP SAS R S-plus Spotfire TSCG Technical knowledge &
complexity needed to create a
basic graphic? No.
(iPad touch
version)
Yes / No
–ODS
GD
Yes,
(progra
m)
As R
Data must be
prepared
Yes / No
Can be
purely
Graphical
Produces Interactive displays
i.e. graphic that allow users to
point on values.
Yes,
brushing, is
dynamic
Yes –
Can be
in html
No
No
Yes
No
Purpose built templates
included (OOTB)
No.
JMP/
Clinical
Only
Yes
(ODS
GD)
No
No
Yes
Yes
Can be audit trailed? Should it
be used for regulator work?
No
Yes
Maybe
~valida
tion?
Yes
No
Yes
High quality resolution graphics
available on Novartis systems?*
Yes
Yes / No
– ODS
GD
Yes
Yes
Yes
Yes
Is it compatible with all OS? e.g.
windows, Unix, Linux, iPad, etc.
No
Yes
Yes
Yes
No
Yes / No
Exploration
&
marketing
Running
predefin
ed
Graphics
Free.
modern
langua
ge
data minip
facil.
BI like
displays, can
be planned
ahead,
Excellent for
Medical
Review
Templates
& Config.
displays
What area does it provide
maximum benefit currently in
Novartis?
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TSCG, SAS 9.3 ODS GD and GPS II Overview
§  GPSII is the Novartis environment created to support clinical
analysis and reporting in terms of traceability and auditability
Ø  Development and final “Production” execution done in a secure
environment
Ø  Ensures compliance to 21 CFR part 11 guidelines
§  Trying to get the best of both worlds!!
Ø  Increase the usage of “out of the box” configurable solutions
Ø  Use existing templates which support the standardization effort
Ø  Easy to modify (configure) templates via GUI
Ø  Integrate graphics applications into our validated environment
Ø  Code generator for secure execution within GPS II
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TSCG, SAS 9.3 ODS GD and GPS II Overview (Cont.)
§  What do TSCG and SAS ODS GD give us “out of the box”?
Ø  Defined set of fixed templates – TSCG: ~25/30 - SAS:~35-40
§  Both solutions allow different user groups to use the tool in
different ways
Ø  Non-technical groups can use the GUI (point and click) as long as they
have access to the data
Ø  Information is saved in graphics configuration files or programs
Ø  Technical groups can then use these to create code and execute in
secure way
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TSCG, SAS 9.3 ODS GD and GPS II Overview (Cont.)
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User View - Tibco Spotfire Clinical Graphics (TSCG).
§  Quick wins:
Ø  Quick and easy to get a first draft and reproduce via SAS macro.
Ø  Works together with SAS macros and SAS data
Ø  Works in GPS environment.
Ø  Good quality graph, easy to have a PDF file as an output or other
format.
Ø  Multiple graphs per page is possible (e.g. Trellis).
§  Challenges:
Ø  Sometimes you need to add some technical imagination to get final
results you require e.g. annotations, information in margins
Ø  Can be difficult to get what you want if it is not produced by “out of the
box” template. Certain amount of “black-box” technology in terms of
the SAS macro code
Ø  If you generate S-Plus code then you need to be able program in S-Plus
to modify.
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User View – SAS ODS Graphics Designer
§  Quick wins:
Ø  Available on our GPS environment with SAS V9.3
Ø  Straight forward to produce a graphic very quickly
Ø  Code generated automatically (no black-box)
Ø  Save straight away in a SAS program and modify as needed
Ø  Easy to create SAS program and reproduce a graph.
Ø  Drag and drop of multiple graphs possible
§  Challenges:
Ø  Still working on making the selection of remote libraries possible
Ø  How do we make this available to user groups who don’t use SAS? –
Stand alone version?
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Conclusion
§  Technology alone may not result in more graphs being created. We
also need to:
Ø  Ensure right tools are used for right jobs!
Ø  Ensure organizational integration is right for the right groups!
Ø  Support users when trying new approaches
§  More agreed “Standard” graphics reports should be defined for use
in CSRs
Ø  More guidance on how and when they should / must be used
§  External enforcement?
Ø  Should we view summary tables a bit like we view listings, that is,
becoming less relevant?
Ø  Remove certain portion of tables as is proposed with all listings?
Ø  Allow only tabular reports which add value and information is
digestible?
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Conclusion (cont.)
§  Could we get more for our resource if we produced more graphical
outputs?
§  Could internal and external reviews be speeded up if we had rules
and regulation on the production of graphical reports?
Ø  Maybe for internal colleagues it also triggers more ideas J / L
§  Could we get a clearer definition from vendors of how to integrate
their technologies into our regulated environment to allow us to
achieve compliance more easily?
Ø  Integration of new technologies is vital!
§  Could the quality of what we produce be enhanced further by using
graphics also as a QC tool?
Ø  Our brain is very good in detecting unusual patterns
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Questions, Thought’s or Comments?
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Back-up1 – Code Produced by SAS ODS GD
proc template;
define statgraph sgdesign;
dynamic _TRT _VISITNUM _TREATMENT;
begingraph;
entrytitle halign=center 'Type in your title...';
entryfootnote halign=left 'Type in your footnote...';
entrytitle halign=center 'Type in your title...';
entryfootnote halign=left 'Type in your footnote...';
layout lattice / rowdatarange=data columndatarange=data rows=1 rowgutter=10 columngutter=10;
layout overlay;
boxplot x=_VISITNUM y=_TRT / group=_TREATMENT name='box' boxwidth=0.4 clusterwidth=1.0;
endlayout;
sidebar / align=bottom spacefill=false;
discretelegend 'box' / opaque=true border=true halign=center valign=center displayclipped=true order=rowmajor;
endsidebar;
endlayout;
endgraph;
end;
run;
options orientation=landscape;
ods rtf file="v:/hartst2_view/CSTSTEST/CSTSTEST0001/util/demo1.rtf";
proc sgrender data=WORK.MEANT template=sgdesign;
dynamic _TRT="TRT" _VISITNUM="VISITNUM" _TREATMENT="TREATMENT";
run;
ODS rtf close;
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Back-up1 – Macro Call from TSCG
%autorun;
%u_prerep;
ods html file="/vob/CCTEST/CCTESTSTUDY1/report/export/pgm_saf/dot_plot.rtf";
%tscg_titles(mainTitle=1[main 1] 2[main 2] 4[main 4],
subTitle=1[sub 1] 3[sub 3],
header=2[head 2] 4[head 4],
footer=1[foot 1] 3[foot 3] 5[foot 5]);
%tscg_Legend(visible=T,
legendLocation=RightCenter,
numberOfColumns=1,
insideLegend=True,
title=Test legend);
%tscg_creategraph(outputFile=/vob/CCTEST/CCTESTSTUDY1/report/export/pgm_saf/dot_plot.png,
graphDoc=/vob/CCTEST/CCTESTSTUDY1/report/pgm_saf/new_box_plot.igd);
ods html close;
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