Clinical Trial Optimization @IMS HealthLeveraging 360⁰ insights to deliver trials on time and on budget
Linda Drumright, General ManagerClinical Trial Optimization Solutions, IMS Health
Disclaimer
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2 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Session Objectives
• How different types of information can be used to influence
What I hope you will learn
ypthe trial planning process
• How to validate trial assumptions and evaluate the operational implications of various performance variables 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 these optimization techniques in their trial operations to achieve better outcomes and deliver their trials more predictably
3 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Delivering Trials On Time and On Budget
• Becoming more predictable requires an organization to test
A Data-Driven Approach to Predictability
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: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?− How many do I think I can get and how fast?− What will it cost me?− What are the risks in my operational plan?
Wh t ld b th ti l t d ff f t ti ?− 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
4 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
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 Profile• Patient Access• Facilities• Capabilities• Performance• Experience
Market Analysis
Patterns – specialists? GPs?
p
Site Profile
Enrollment ModelsCost Considerations
5
Site Selection
October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Real World Evidence
Feasibility - assess and ti i I/E it i
Apply I/E criteria against relevant patient population
Select best data source for your specific protocol
optimize your I/E criteriaLongitudinal
Rx data(10 countries)Health
plan data(US)
OncologyEMR data
(US)
400m Globali i
Non-Oncology EMR data
( )
Medical pharmacy
(US)
Country Allocation & Site Selection – find
countries/sites with relevant patients
Patient Lives EMR data(US, UK, FR, DE)claims
(US)
Medical Lab data
(US)Oncology
survey data(11 countries)
Medical survey data(44 countries)
6 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Customer Case Study: Global Pharmaceutical Co #1
• Situation− All subjects failing screening by not meeting a lab requirement in protocol
Optimizing a Protocol
• Total Testosterone <5nmol/L at screening
− Question of what is normal vs abnormal and whether to change protocol
• Analysisy− 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 #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.
• RecommendationR i t t t ti i t l− Re-review testosterone assumptions in protocol
7 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Customer Case Study: Global Pharmaceutical Co #2U d t di th S iti it f I/E C it iUnderstanding the Sensitivity of I/E Criteria
Asthma attrition funnel: inclusion criteria
8 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Customer Case Study: Global Pharmaceutical Co #2U d t di th S iti it f I/E C it iUnderstanding the Sensitivity of I/E Criteria
9 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
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 il blavailable
• 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 recordsg y g
• Successful translation of clinical criteria into a selection algorithm requires an appreciation of limitations of the data source
10 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and
Retention Summit
Creating an Optimal Plan
Who
Validate Assumptions Protocol Optimization
Exclusion
Inclusion
Patient Definition Site Definition Id l C t i Global Ideal CountriesMetrics Number of sites
Patient
1572
Number of countries
Patient Access Site Selection
ExperiencedInvestigators
USA
Sit S l tiTime/Cost Trade-offs
Site Selection/
December 201311IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Site Profiles with Patient Access
Find sites with recent trial experience
Find sites with patients Find sites with patients meeting the
inclusion/exclusion criteria
12 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Patient Access Proximity
13 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Geographic Cost Implications
14© IMS Health, GrantPlan 2013
October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Startup and Enrollment Implications
15 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Customer Case Study: Global Pharmaceutical Co. #3• Challenge
− Limited historical data to support enrollment planning
• Reliant on CRO plan and enrollment status/projections 35
40
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 i20
25
30
Canada
US− Systemic Country and Site Performance issues• Most sites not starting until end of enrollment• Many countries with significant start up delays
• SolutionR t ti l i i b h k t t
5
10
15
− 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
0Planned 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
16
Projected LSE 10 days from actual LSE at 60% of subjects enrolled
October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Optimal Site Selection
Public domainCt gov 3rd party
Data Sources
Industry Site Benchmarks
Claims pha macies Client systemsEDC CTMS IVRS
IMS HealthG Pl
Your own site performance
Industry-wide site performance
Patient access, site affiliations
Site experience and capacity
Ct.gov, 3 party data providers.
Site Selection C it i
Claims, pharmacies, health plans, EMRs,
etc.
EDC, CTMS, IVRS, internal warehouses
GrantPlan cost benchmarks
GrantPlan
Criteria
Sit O ti i• Fact driven process• Intuitive, visual analysis
• Common interface for site selection• Access to “Naïve Sites” performance
SiteOptimizer
• Predictive analytics• 2-way CTMS integration• Enables StudyOptimizer
ccess to a e S tes pe o a ce• Patient availability and Site contact info• Integrated cost insights• Global Unique identifiers
WHY IMS
17 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Compare Investigator Performance and Experience
18 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Segment by performance categories to build roster
19 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Scenario Modeling – Weighing the Options
20 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Baseline and Execute to Plan
Track progress and see projections for site initiation.
T k d Track progress and see projections for screening.
Track progress and see j ti f projections for
randomization..
21 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Customer Case Study: Global Pharmaceutical Co. #4
Challenge• Limited recruitment performance predictability• Lack of visibility into the ‘truth’ (multiple data
Studies Recruiting to Plan65%
sources, manual processing)• Financial pressures (cost and capacity)
Solution• Implemented IMS Health’s Global Enrollment 50%
55%
60%
head
of T
ime
ead
of
Tim
e
Implemented IMS Health s Global Enrollment Planning and Tracking platform
• Automated multiple data feeds into single data warehouse
• Trained staff, mandated use40%
45%
% o
f Stu
dies
on/
ah
Client mandates use of the IMS Health platform
for all studies
Client mandates use of the IMS Health platform
for all studies
tud
ies
on
/ah
• Established approved recruitment plans prior to start of recruitment− Managed entire trial thru the platform 30%
35%
Jan
Apr Jul
Oct
Jan
Apr Jul
Oct
Jan
Apr Jul
OctYear 1 Year 2 Year 3
PilotPilot
% o
f S
tRESULTS:• 100% increase in studies recruiting to plan (exceeded 50% target)• Automated reporting, improved visibility• 1/3 decrease in non-performing sites
22
1/3 decrease in non performing sites
October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Conclusion
• Data and technology combined with the right analytics can help you gain a 360-degree perspective of this very complex p y g g p p y pset 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 y g p , y
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 happensmore quickly to what actually will happen before it happens− You can set and manage to more realistic expectations
23 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Questions?
24 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit
Thank You!
[email protected] l hwww.imshealth.com
and stop by the IMS Health booth
25 October 2014IMS Health Clinical Trial Optimization Solutions - Patient Recruitment and Retention Summit