Effective visuals to support the entire clinical study team

1. Optimum use of visualisations to minimise clinical and operational risk,
enhance data quality and reduce cycle time in Late Phase Clinical Trials
Neill Barron
Clinical Data Manager & Analytics Consultant
February, 2016

2. What is Spotfire?
Spotfire is a data visualisation tool—a “One-Stop-Shop” to
review and link data from multiple sources (CTMS, EDC,
External Vendors etc.) in one place. Use it to:
1. INVESTIGATE: Easily interrogate data to look for outliers, signals and
missing values in real-time.
2. LEVERAGE DATA: Compare information across multiple data sources to
gain additional insights.
3. BOOST PRODUCTIVITY: Reduce the study team’s time trawling through
data by taking advantage of the tool’s user friendly environment.

3. Data Visualization with Spotfire
Accelerate decision making & enhance in-stream study & data quality
Spotfire
What is Spotfire ?
Spotfire is a data visualisation tool—a “One-Stop-
Shop” to review and link data from multiple sources in
one place.
Spotfire enables early identification of clinical data
trends, patterns and outliers, via graphical
visualisations, to accelerate decision making and
enhance in-stream study quality at reduced cost.
Why use Spotfire?
• Visualise data in graphs rather than in lists or
reports to improve ability to see signals, detect
issues with data quality and notice operational
quality trends.
• Save time and money; enhance quality.
What is the functionality of
Spotfire?
• Seamless linking of data from multiple sources to
provide a single view and rapid drill-down and
filtering of data across data sources
• Easy development of a variety of charts (box,
scatter, line etc) and tables to perform a “holistic”
review of data
• Instantaneous “zoom in” on data of interest from
the study level to the aggregate level through to the
patient level
Where Spotfire adds value
1. Increase study quality: better detect
& prevent study quality issues (e.g.
protocol deviations, operational
issues, drop-outs)
2. Enhance data quality: early
identification of data quality trends to
drive proactive, preventative actions
(e.g. site training)
3. Accelerate decision making:
reduce time to access graphical
visualizations of data & reduce time to
analyze & understand data
4. Decreased study cost: Reduce the
amount of time reproducing data
listings/static graphs to support in-
stream working. Earlier
detection/correction of issues saves
time and money.
How Spotfire supports different roles
Clinical Study Lead
Easy, interactive and independent exploration and research of
in-stream clinical and operational data.
Data Management & Site Monitoring
Visual identification of outliers, recurrent data quality issues
and/or data quality trends that have not been highlighted by
existing queries.
Statistician
Enables statistician to create and review in-stream graphs and
patient profiles.
Clinical Operations Manager
Enables viewers to dynamically drill-down and examine data to
help explain/identify clinical study conduct issues and trends.
Medical Monitor and Project Physician
Allows in-stream visualisation of clinical data via Patient
Profiles across all safety and efficacy datasets and across
studies in a single view
And allows rapid identification of
OR A “multi” view on a single data type to identify
outliers and trends
A “single” view to visualize many types of
interconnected data

4. Why use Spotfire?
Medic Data Manager Clinical Study Lead Statistician
Unique
Selling
Points?
Easy, interactive and
independent
exploration and
research of in-stream
clinical and
operational data.
Visually identifies outliers,
recurrent data quality
issues and/or data quality
trends that have not been
highlighted by existing
queries
Enables viewers to
dynamically drill-down and
examine data to help
explain/identify clinical
study conduct issues and
trends
Enables statistician to
create and review in-
stream graphs and
patient profiles
Benefits
• Use data to make
decisions
throughout a study.
• Easier Medical
Oversight using
intuitive graphics
rather than data
listings
• Easy overall study
oversight
• Use data to drive
actions and have
focussed conversations
with CRAS and
investigator sites.
• Increase efficiency using
intuitive, visual data
instead of time
consuming, error prone
manual checking of lists.
• A “one-stop shop” to
easily identify, investigate
and then address clinical
study conduct issues (e.g.
Protocol violators)
suggested by clinical data.
• Review of operational
performance
visualisations with the
ability to drill into the detail
to identify and address
root causes.(e.g. Reason
for screen failures/run-in
failures, operational data
such as recruitment, site
performance etc.)
• Early reviews of data
visualisations will allow
early detection and
prevention of data
issues.
• Review and feedback
of spotfire graphic/
visualisations can
reduce time needed to
produce/approve formal
displays.
• Replaces need to
produce ad hoc
reports and listings

5. Functionality and Demo Visualisations

6. Visual Supporting Statistician, Study Lead and Data Manager

7. Protocol Violations

8. Medical Monitor Oversight

9. Comparison Plots

10. Safety Overview

11. Study Population Overview for Info and Data
marking