Partnerships in Clinical Trials 2014

The State of Clinical Outsourcing:

Impact of Outsourcing Partnerships on Clinical Trial

Optimization

Data from the 2014 Avoca Industry Survey

Partnerships in Clinical Trials

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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

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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.

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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

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●  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.


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●  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)?


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●  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

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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

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% 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

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% of Respondents Reporting at least “Moderate Advances” in the Use of “Intelligent” Approaches over the Last 2 years


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Site selection

Provider selection

Region selection


Monitoring


Protocol procedures/eligibility criteria




Results: Rate of Advancement

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% of Respondents Reporting “Great Advances” in the Use of “Intelligent” Approaches over the Last 2 years


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Site selection

Monitoring


Provider selection



Region selection


Specific protocol procedures or eligibility criteria



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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

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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

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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)




Other operational processes

Provider selection

Specific protocol procedures or eligibility criteria

Overall protocol designs (e.g. adaptive)


Essential contribution Significant contribution Little contribution

No contribution Negative contribution

N 70

69

73

72

67

68

56

55

66

57

57

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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

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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



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Sponsors Providers

Change management issues

X X X X X X

X X X X X X



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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

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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.

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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

Thank you

Contact Avoca at: (609) 252-9020

www.theavocagroup.com

[email protected]

179 Nassau Street Suite 3A

Princeton, NJ 08542

Health & Medicine

Partnerships in Clinical Trials 2014