IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA

1. Clinical Trial Optimization @IMS Health
Leveraging 360⁰ insights to deliver trials on time and on budget
Linda Drumright, General Manager
Clinical Trial Optimization Solutions, IMS Health

2. Disclaimer
• The opinions expressed in this presentation and on the
following slides are solely those of the
presenter and not necessarily those of Allan Lloyds.
•• Allan Lloyds does not guarantee the accuracy or reliability of
the information provided herein
• These PowerPoint slides are the intellectual property of the
individual presenter and are protected under the copyright
laws of the United States of America and other countries.
Used by permission. All rights reserved. All trademarks are
the property of their respective owners.
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
2 October 2014

3. Session Objectives
What I hope you will learn
• How different yp
types of information can be used to influence
the trial planning process
• How to validate trial assumptions and evaluate the
operational implications of various performance variables
through the use of data, technology and predictive analytics
• How some sponsors and CROs are successfully leveraging
these optimization techniques in their trial operations to
achieve better outcomes and deliver their trials more
predictably
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
3 October 2014

4. Delivering Trials On Time and On Budget
A Data-Driven Approach to Predictability
• Becoming more predictable requires an organization to test
and validate as many assumptions as possible that can impact
timelines and costs or create volatility during execution
• Many types of insights drive answers to key questions:
− Are there patients in the world that match the I/E criteria?
− Where are they and who has access to them?
− How many do I think I can get and how fast?
− What will it cost me?
− What are the risks in my operational plan?
− What would be the optimal tradeoffs of cost versus time?
• Predictive analytics can be used to measure and weigh the
tradeoffs so the most effective courses of action are chosen
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
4 October 2014

5. Assessment of Operational Feasibility
Patient Profile
Validate / Challenge
• Epidemiology
• Competition
•Standard of Care
• Regulatory Landscape
• Demographics – age,
insurance status, income
• Treatment Behaviors and
Patterns specialists?
• Patient Access
• Facilities
• Capabilities
• Performance
• Experience
Market Analysis
– GPs?
p
Site Profile
Enrollment Models
Cost Considerations
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
5
Site Selection
October 2014

6. Real World Evidence
Apply I/E criteria against relevant patient population
Feasibility - assess and
ti i I/it i
Select best data source for your specific protocol
optimize your E criteria
Longitudinal
Rx data
Health (10 countries)
plan data
( US)
Oncology
EMR data
(US)
400m Global
i i
Non-Oncology
EMR data
)
Medical
pharmacy
Country Allocation & Site
Selection – find
countries/sites with
relevant patients
Patient Lives claims (US, UK, FR, DE)
(US)
Medical
Lab data
(US)
Oncology
survey data
(11 countries)
survey data
(44 countries)
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
6 October 2014

7. Customer Case Study: Global Pharmaceutical Co #1
Optimizing a Protocol
• Situation
− All subjects failing screening by not meeting a lab requirement in protocol
• Total Testosterone <5nmol/L at screening
− Question of what is normal vs abnormal and whether to change protocol
• Analysis
− Normal TOTAL testosterone levels in females who are not pregnant:
• PREmenopausal women: 0.347 nmol/L to 1.9085 nmol/L
• POSTmenopausal women: 0.2429 nmol/L to 1.388 nmol/L
− Client range seems appropriate but may be high (Total Testosterone
<2nmol/L might be more appropriate, but would not yield different results.)
− It appears they are looking for low Total testosterone, however, criterion
#2 requires Free Testosterone to be above normal - a contradiction. If Free
testosterone is above normal, it is unlikely that total will be below normal.
• Recommendation
− Re-review testosterone assumptions in protocol
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
7 October 2014

8. Customer Case Study: Global Pharmaceutical Co #2
U d t Understanding the Sensitivity of I/E Criteria
Asthma attrition funnel:
inclusion criteria
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
8 October 2014

9. Customer Case Study: Global Pharmaceutical Co #2
U d t Understanding the Sensitivity of I/E Criteria
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
9 October 2014

10. Key lessons using EHR data to evaluate asthma patients
• Asthmatics can be identified using EHRs
• Data on a substantial proportion of pharmacological asthmatic management is
available
• The majority of elements of a clinical trial protocol can be translated into a
selection process to apply to EHR data
• Assessing continuity of asthmatic medication requires a more flexible definition or
a probabilistic or predictive approach
• Severe asthmatics may not receive all of their care in a GP setting, so choice of
clinical data source is critical
• Data relating to severe exacerbations may be missing from claims and GP records
• Successful translation of clinical criteria into a selection algorithm requires an
appreciation of limitations of the data source
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and
10 October 2014
Retention Summit

11. Creating an Optimal Plan
Validate Assumptions Protocol Optimization
Who
Exclusion
 Patient Definition
 Site Definition
 Id l C t i Global Ideal Countries
 Metrics
Inclusion
 Number of sites
Patient
1572
 Number of countries
 Patient Access
 Site Selection
Experienced
Investigators
USA
Sit S l ti
Time/Cost Trade-offs
Site Selection
/
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
11 December 2013

12. Site Profiles with Patient Access
Find sites with recent
trial experience
Find sites with patients
meeting the
inclusion/exclusion
criteria
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
12 October 2014

13. Patient Access Proximity
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
13 October 2014

14. Geographic Cost Implications
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
14
© IMS Health, GrantPlan
2013
October 2014

15. Startup and Enrollment Implications
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
15 October 2014

16. Customer Case Study: Global Pharmaceutical Co. #3
• Challenge
− Limited historical data to support enrollment
planning
40
• Reliant on CRO plan and enrollment status/projections 35
Benchmarks
Benchmarks
• Lack of accurate forecasting capabilities
− Critical trial with 13+ month delay
• Delay not recognized until very late
• Leading to increased enrollment timelines and budget
S t i C t d Sit P f i
30
25
Canada
20
US − Systemic Country and Site Performance issues
• Most sites not starting until end of enrollment
• Many countries with significant start up delays
• Solution
R t ti l i i b h k t t
15
10
5
− Retrospective analysis using benchmarks on start-up
and enrollment, as well as predictive analytics
along the course of the trial, proved a data-driven
approach would have yielded significantly better
results
0
Planned Achieved
RESULTS:
• 11+ month delay identified prior to study start through benchmark data
• Projected LSE 10 days from actual LSE at 60% of subjects enrolled
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
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October 2014

17. Optimal Site Selection
Public domain
Ct gov 3rd party
Data
Sources
Industry Site
Benchmarks
Claims pha macies
Client systems
EDC CTMS IVRS
IMS Health
G Pl
Your own site
performance
Industry-wide site
performance
Patient access,
site affiliations
Ct.gov, 3 data providers.
Site experience
and capacity
Site
Selection
C it i
Claims, pharmacies,
health plans, EMRs,
etc.
EDC, CTMS, IVRS,
internal warehouses
GrantPlan
GrantPlan cost
benchmarks
Criteria
Sit O ti i
SiteOptimizer
• Fact driven process
• Intuitive, visual analysis
• Common interface for site selection
• Access to “Naïve Sites” performance
• Predictive analytics
• 2-way CTMS integration
• Enables StudyOptimizer
ccess a e S tes pe o a ce
• Patient availability and Site contact info
• Integrated cost insights
• Global Unique identifiers
WHY
IMS
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
17 October 2014

18. Compare Investigator Performance and Experience
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
18 October 2014

19. Segment by performance categories to build roster
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
19 October 2014

20. Scenario Modeling – Weighing the Options
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
20 October 2014

21. Baseline and Execute to Plan
Track progress and see
projections for site
initiation.
Track progress and see
projections for screening.
Track progress and see
projections for
randomization..
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
21 October 2014

22. Customer Case Study: Global Pharmaceutical Co. #4
Challenge
• Limited recruitment performance predictability
• Lack of visibility into the ‘truth’ (multiple data
Studies Recruiting to Plan
65%
sources, manual processing)
60%
• Financial pressures (cost and capacity)
55%
Solution
• Implemented IMS Health’s 50%
heeaadd o fo Tfim Teime
Health s Global Enrollment
Planning and Tracking platform
• Automated multiple data feeds into single data
45%
warehouse
40%
• Trained staff, mandated use % of Studies on/ah
Client mandates use of
the IMS Health platform
for all studies
tudies on/ah
• Established approved recruitment plans prior to
start of recruitment
35%
− Managed entire trial thru the platform 30%
Pilot
Jan
Apr
Jul
Oct
Jan
Apr
Jul
Oct
Jan
Apr
Jul
Oct
Year 1 Year 2 Year 3
% of St
RESULTS:
• 100% increase in studies recruiting to plan (exceeded 50% target)
• Automated reporting, improved visibility
• 1/3 decrease in non-performing sites
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
22
non October 2014

23. Conclusion
• Data and technology combined with the right analytics can
help you gain a 360-degree perspective of this very complex
set of problems:
− You create a protocol that is feasible from the start
− Even if you can’t change the protocol, you can execute it more
knowledgably
− You can plan for what a patient is most likely to look like rather than one
that is conceptual
− You can leverage your own and others’ experience through real world
historical data
− You can predict more accurately what will happen and you can respond
more quickly to what actually will happen before it happens
− You can set and manage to more realistic expectations
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
23 October 2014

24. Questions?
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
24 October 2014

25. Thank You!
Linda.Drumright@us.imshealth.com
www.imshealth.com
and stop by the IMS Health booth
IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
25 October 2014