The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress toward Clinical Trial Optimization?

1. The State of Clinical Outsourcing:
Do Outsourcing Partnerships Promote or Impede
Progress toward Clinical Trial Optimization?
Data from the 2014 Avoca Industry Survey
Denise Calaprice-Whitty, Ph.D.
Senior Consultant
The Avoca Group
@TheAvocaGroup

2. Disclaimer
• The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and should not be
attributed to Drug Information Association, Inc. (“DIA”), its directors,
officers, employees, volunteers, members, chapters, councils,
Communities or affiliates, or any organization with which the
presenter is employed or affiliated.
• 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. Drug Information Association, Drug
Information Association Inc., DIA and DIA logo are registered
trademarks. All other trademarks are the property of their respective
owners.
2

3. 3
Panel Members
Denise Calaprice-Whitty, Ph.D. (Moderator)
Senior Consultant, The Avoca Group
Rhonda Henry
Vice President of Alliance Management and Strategic Sales, PPDI
Elspeth Carnan, Ph.D.
Executive Director, Center of Operational Efficiency, Innovation,
and Process Improvement, Global Development Ops, Amgen
Kathleen Ford
Senior Vice President, Head of Global Clinical Operations, Merck

4. 4
2014 Avoca Industry Survey
The Big Question:
How are “intelligent,”
data-driven approaches*
being used in clinical
development today?
What factors promote their use, and
what factors inhibit it (with a focus on
outsourcing)?

5. 5
Survey Definition
* “Intelligent,” data-driven approach:
One that makes use of operational (e.g. performance) and/or clinical
data…
along with appropriate analytical techniques,
in order to optimize aspects of clinical development (protocol design,
Investigator selection, patient recruitment approaches, resource allocation,
e.g. risk-based monitoring), etc.

6. 6
Background: 2014 Avoca Industry Survey
Why now?
• “Big Data” concepts have become part of our daily experience,
with successful and highly visible use in other industries
• In our industry, unprecedented availability and aggregation of
digital information
– Even further promoted by high rates of outsourcing
• Continued time, cost, and quality pressures on clinical
development
• Clear areas of opportunity

7. 7
• Areas of opportunity, examples:
– Overall protocol design
– Procedural or eligibility aspects of protocols
– Selection of sites, regions, providers, or patient
recruitment approaches
– Project management/oversight
As with any change, however, companies must recognize
and effectively manage the forces that impact uptake and
success.
Background: 2014 Avoca Industry Survey

8. 8
Specific research questions addressed:
• Frequency of use of “intelligent” approaches in different key
areas
• Rate of advancement over the last 2 years
• Forces contributing (positively or negatively) to advancement
– General
– Impact of outsourcing partnerships and outsourcing models
• Early engagement of partners in protocol and development planning
• Experience with technology, training, and other implementation
and change management solutions
Background: 2014 Avoca Industry Survey

9. 9
2014 Avoca Industry Survey: Respondents
Sponsors:
127 Respondents
• Approximately 45% in top 20 in terms
of revenue
– 67% Pharma
– 28% Biotech
– 3% Device
– 2% Combination/Other
Clinical Service Providers:
105 Respondents
• 64% in top 20 in terms of revenue
– 67% CROs
– 33% Other/Niche

10. 10
Results: Application of Approaches
How frequently are “intelligent”
approaches applied?
How much advancement has been
made in the last 2 years?

11. 11
% of Respondents Reporting that Most of their Clinical Trials Use
“Intelligent” Approaches
(activities performed by the respondent’s company)
0% 20% 40% 60%
Provider selection
Cost benchmarking/
management
Region selection
Specific protocol procedures
or eligibility criteria
Site selection
Project management/
oversight
Overall protocol designs
Data collection tools
Patient/volunteer
recruitment
Monitoring
(e.g. risk-based)
Sponsors (N=87)
0% 20% 40% 60%
Site selection
Region selection
Project management/
oversight
Cost benchmarking/
management
Data collection tools
Provider selection
Specific protocol procedures
or eligibility criteria
Patient/volunteer
recruitment
Monitoring
(e.g. risk-based)
Overall protocol designs
Providers (N=62)

12. 12
% of Respondents Reporting at least “Moderate Advances” in the Use of
“Intelligent” Approaches over the Last 2 years
(activities performed by the respondent’s company)
0% 20% 40% 60% 80%
Provider selection
Site selection
Project management/
oversight
Overall protocol designs
Specific protocol procedures
or eligibility criteria
Cost benchmarking/
management
Region selection
Data collection tools
Monitoring
Patient/volunteer
recruitment
Sponsors (N=84)
0% 20% 40% 60% 80%
Region selection
Site selection
Data collection tools
Monitoring
Provider selection
Specific protocol procedures
or eligibility criteria
Project management/
oversight
Cost benchmarking/
management
Overall protocol designs
Patient/volunteer
recruitment
Providers (N=65)

13. 13
% of Respondents Reporting “Great Advances” in the Use of
“Intelligent” Approaches over the Last 2 years
(activities performed by the respondent’s company)
0% 10% 20% 30% 40%
Provider selection
Overall protocol designs
Data collection tools
Monitoring
Project management/
oversight
Cost benchmarking/
management
Patient/volunteer
recruitment
Specific protocol procedures
or eligibility criteria
Site selection
Region selection
Sponsors (N=84)
0% 10% 20% 30% 40%
Site selection
Monitoring
Data collection tools
Patient/volunteer
recruitment
Region selection
Overall protocol designs
Provider selection
Project management/
oversight
Specific protocol procedures
or eligibility criteria
Cost benchmarking/
management
Providers (N=65)

14. 14
Results: Impact of Outsourcing on
Application
To what extent does the use of “intelligent”
approaches depend (positively or negatively)
on outsourcing?
Why and in what ways?

15. 15
Sponsors: To what extent do your company's clinical service
providers either contribute to, or detract from, your company's
use of "intelligent” clinical development approaches?
19%
14%
21%
22%
7%
15%
4%
7%
3%
7%
50%
43%
37%
35%
37%
29%
36%
31%
26%
21%
26%
27%
35%
32%
36%
36%
41%
50%
40%
52%
46%
39%
3%
6%
7%
6%
13%
15%
11%
20%
20%
26%
26%
4%
6%
9%
0% 20% 40% 60% 80% 100%
Site selection
Region selection
Monitoring (e.g. risk-based monitoring)
Patient/volunteer recruitment
Project management/oversight
Data collection tools
Other operational processes
Provider selection
Specific protocol procedures or eligibility
criteria
Overall protocol designs (e.g. adaptive)
Cost benchmarking/management
Essential contribution Significant contribution Little contribution
No contribution Negative contribution
N
70
69
73
72
67
68
56
55
66
57
57

16. 16
Provider Contributions
• Availability of data
• Availability of models and experience
• Understanding of regulatory perspective
• Technology
• Resource availability

17. 17
Levels of Satisfaction with the Application of
“Intelligent" Approaches
(rating scale 1=very dissatisfied to 5=very satisfied)
Sponsor ratings
Difference
Service
provider
self ratings
In-house
teams
Service
providers
N= 65 54 54
Cost benchmarking/management 3.3 2.5 0.8 3.2
Provider selection 3.4 2.9 0.5 3.4
Overall protocol designs (e.g.
adaptive)
3.4 2.9 0.5 3.8
Specific protocol procedures or
eligibility criteria
3.4 3.0 0.4 3.7
Project management/oversight 3.4 3.0 0.4 3.4
Site selection 3.3 3.1 0.2 3.9
Region selection 3.4 3.3 0.1 3.7
Patient/volunteer recruitment 3.2 3.1 0.1 3.6
Data collection tools (e.g. designs
associated with lowest query rates)
3.4 3.3 0.1 3.7
Other operational processes 3.2 3.1 0.1 3.4
Monitoring (e.g. risk-based monitoring) 3.1 3.1 0 3.5

18. 18
Sponsors: For outsourced clinical trials, how often do you engage
CROs early in the clinical trial execution process in order to leverage
their experience?
19%
43%
31%
5% 2%
Always
Most of the time
Sometimes
Seldom
Never
N=86

19. 19
Sponsors: Collaboration with CROs on
Protocol Design
7%
16%
29%24%
24%
Always
Most of the time
Sometimes
Seldom
Never
17%
54%
23%
5% 1% Greatly
Somewhat
Little
None
Reduces protocol
quality
For outsourced clinical trials, how
often do you collaborate with your
CROs on protocol design?
To what extent do you feel that
collaboration with CROs on
protocol design improves quality?
N=83 N=76

20. 20
Results: Impact of Outsourcing on
Application
Does the outsourcing model make a difference?

21. 21
Impacts of Full-Service vs. Functional
• Strong opinions in both directions!
• Full-service outsourcing:
– Promotes approaches that require data to be shared, or tasks to be
coordinated, across functional areas (e.g. fully integrated intelligent
technologies)
– Promotes greater sense of ownership among CROs, hence promoting use
of more optimized approaches
– But can impede optimization since much is limited by weakest provider
areas
• Functional outsourcing:
– Promotes excellence and efficiency in single tasks

22. 22
Impacts of Strategic Alliances
• Positive impacts:
– Aggregation of data for partnership studies
– Access to data as part of Agreement
– Greater investment in aligned systems, metrics, processes
– Cost benefits allow more resources to be directed toward innovation
– Dedicated resources: positive impact on resource availability
– Increases trust, hence willingness to innovate
– More cooperation in early stages of programs ◊ opportunity to
discuss and plan
– Partners under increased pressure to show value, so come up with
more creative approaches

23. 23
Impacts of Strategic Alliances
• Negative impacts:
– Lack of competition removes incentive to innovate
• get “comfortable”
– Fewer benefits of cross-vendor expertise
• constrains alliance partners from freely partnering to
leverage unique systems and tools.

24. Thank you
Denise Calaprice-Whitty, Ph.D.
Senior Consultant
The Avoca Group
@TheAvocaGroup
Join the conversation #dia2014
24