The State of Clinical Outsourcing: Impact of Outsourcing Partnerships on Clinical Trial Optimization

1. The State of Clinical
Outsourcing:
Impact of Outsourcing
Partnerships on Clinical Trial
Optimization
Data from the
2014 Avoca Industry Survey
Partnerships in Clinical Trials

2. 2
Denise Calaprice-Whitty, Ph.D. (Moderator)
Senior Consultant, The Avoca Group
Coleen Glessner
VP, Clinical Trial Process & Quality, Pfizer
Jamie MacDonald
CEO, Clinical Services, INC Research
Marisa Co
Vice President, BMS
Panel Members
Graeme Currie, Ph.D.
Vice President, Clinical Project Management and Operations,
Regeneron Pharmaceuticals

3. 3
2014 Avoca Industry Survey
Big Question:
How are “intelligent,” data-driven
approaches* being used in clinical
development today?
What factors promote their use, and
what factors inhibit it?
*For the purpose of this survey, an “intelligent,” data-driven approach was
defined as 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 such as protocol design, Investigator
selection, patient recruitment approaches, resource allocation (e.g. risk-based
monitoring), etc.

4. 4
Background: 2014 Avoca Industry Survey
Why now?
╸ “Big Data” concepts have become part of our daily experience
╸ Successful and highly visible use in other industries
o Moneyball
o Netflix
o Credit companies
o Facebook
╸ Clear opportunity in our industry
╸ Unprecedented availability and aggregation of digital information
╸ Even further promoted by high rates of outsourcing
╸ Continued time, cost, and quality pressures
╸ Easy to imagine areas of opportunity

5. 5
● Areas of opportunity, examples:
╸ overall protocol design, e.g. adaptive study designs, i.e. those adjusted
during the course of a study based on biomarker or clinical study data
gathered during the study
╸ procedural or eligibility aspects of protocols, e.g. examination of data
from previous studies to identify procedures/criteria associated with
high levels of protocol violations, cost, screen failures, etc. vs. value of
the data received
╸ selection of sites, regions, providers, or patient recruitment approaches,
e.g. use of performance databases to identify optimal selection for a
given function or study
╸ project management/oversight , e.g. data- or formula-based
identification of areas/periods of low/high risk, in order to allocate
oversight resources accordingly.
As with any change, however, companies must recognize and effectively
manage the forces that impact uptake and success.
Background: 2014 Avoca Industry Survey

6. 6
● Therefore, the 2014 Avoca Industry Survey explored the impact of
outsourcing relationships on this area.
● Specific research questions included:
╸ How frequently are “intelligent” approaches applied to each key area?
Among sponsors, how and why does this differ for in-house vs. outsourced
activities?
╸ How much advancement has been made over the last 2 years?
╸ How satisfactory are the results that are being seen?
╸ What forces have contributed to advancement, and what has impeded
it? What has been the impact of outsourcing partnerships?
╸ Experience with technology, training, and other implementation and
change management solutions
╸ Early engagement of partners in protocol and development planning:
Do you do it? Does it promote use of “intelligent” approaches? Does it
improve quality? How?
╸ Is the use of intelligent approaches impacted by the outsourcing model
employed (strategic vs. transactional, full-service vs. FSP)?
Background: 2014 Avoca Industry Survey

7. 7
● Sponsors: 127 Respondents
╸ Approximately 45% in top 20 in terms of revenue
o 67% Pharma
o 28% Biotech
o 3% Device
o 2% Combination/Other
● Clinical Service Providers: 105 Respondents
╸ 64% in top 20 in terms of revenue
o 67% CROs
o 33% Other/Niche
Respondents
2014 Avoca Industry Survey: Respondents

8. 8
Results: Application of Approaches
How frequently are “intelligent”
approaches applied?
How much advancement has
been made over the last 2 years?
How satisfactory have been the
results?
Questions 1, 2, and 3

9. 9
% of Respondents Reporting that Most of their Clinical Trials Use “Intelligent”
Approaches
(activities performed by the respondent’s company)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Region selection
Site selection
Cost benchmarking/management
Provider selection
Project management/oversight
Protocol procedures/eligibility
Data collection tools
Overall protocol designs
Patient/volunteer recruitment
Monitoring (e.g. risk-based)
Sponsors (N=87) Providers (N=62)
Results: Application of Approaches

10. 10
% 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% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Site selection
Provider selection
Region selection
Data collection tools
Monitoring
Project management/oversight
Protocol procedures/eligibility
criteria
Overall protocol designs
Cost benchmarking/management
Sponsors (N=84) Providers (N=65)
Results: Rate of Advancement

11. 11
% 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% 50% 60% 70% 80% 90% 100%
Site selection
Monitoring
Data collection tools
Provider selection
Patient/volunteer recruitment
Overall protocol designs
Region selection
Project management/oversight
Specific protocol procedures or
eligibility criteria
Sponsors (N=84) Providers (N=65)
Results: Rate of Advancement

12. 12
For each of your in-house teams and your clinical service providers, please rate
your levels of satisfaction (1 to 5) with the application of "intelligent" (data-
driven) approaches on your projects, in each of the below areas.
Satisfaction with“Intelligent” Approaches
Sponsor ratings Clinical service
provider
self ratings In-house teams
Clinical service
providers
N= 65 54 54
Overall protocol designs (e.g. adaptive) 3.4 2.9 3.8
Specific protocol procedures or eligibility criteria 3.4 3.0 3.7
Site selection 3.3 3.1 3.9
Region selection 3.4 3.3 3.7
Provider selection 3.4 2.9 3.4
Patient/volunteer recruitment 3.2 3.1 3.6
Data collection tools (e.g. designs associated with
lowest query rates)
3.4 3.3 3.7
Monitoring (e.g. risk-based monitoring) 3.1 3.1 3.5
Other operational processes 3.2 3.1 3.4
Cost benchmarking/management 3.3 2.5 3.2
Project management/oversight 3.4 3.0 3.4

13. 13
Results: Rate of Advancement
Which aspects of progress have
depended (positively or negatively)
on outsourcing relationships,
and to what extent?
What types of change management
initiatives have made a positive
difference?
Questions 4 and 5

14. 14
Contributions of Service Providers: Sponsors
In your opinion, 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%
1%
1%
4%
1%
6%
2%
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

15. 15
Do Partnerships Promote or Impede?
Sponsors Providers
Availability of data X
X
X
X
X
X
X
X
X
X
X
X
Availability of models and experience
Understanding of regulatory perspective
Technology
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement

16. 16
Do Partnerships Promote or Impede?
Sponsors Providers
External pressures
X
X
X
X
X
X
X
X
X
X
X
X
Resources
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement

17. 17
Do Partnerships Promote or Impede?
Sponsors Providers
Change management issues
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement

18. 18
Sponsor and Provider Data
Has your company implemented any specific change management initiatives to
help accelerate/improve the adoption of "intelligent" approaches to clinical trial
design and execution?
55%
63%
45%
37%
0% 20% 40% 60% 80% 100%
Sponsors
Clinical
Service
Providers
Yes No
N
69
52

19. 19
Sponsor and Service Provider Verbatim
● Increased resourcing in this area, creation of new roles (and/or service offerings) with
targets and accountability
● SOPs and process improvements, including joint sponsor-provider
● New technology
● Better data collection, review, analysis skills and tools
● Enhanced partnering/subcontracting initiatives
● Surveys to assess status and changes
● “Ambassador” programs
● Intensive and detailed training initiatives
● Broad employee engagement in designing changes
● Measurement of impact/ROI; case studies to show benefits
● Encouraging full risk assessment so that efforts are focused in the right place
Ø Importance of global initiatives supported by senior management
If "Yes", please briefly describe initiative and impact.

20. 20
Key Take-Aways
● Abundant opportunities exist for the application of “intelligent,” data-driven
approaches in clinical development.
● Many people believe that their companies have made substantial progress
in this area over the last two years.
● Outsourcing relationships may enhance uptake of such approaches,
principally by increasing access to aggregated data, expertise, and
experience.
● However, outsourcing relationships may also present challenges to uptake, in
the form of issues with change management and/or coordinated planning,
and in some cases, potential conflicts of interest.
Key Take-Aways

21. Thank you
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princeton, NJ 08542