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

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

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

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

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

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

•  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

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

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

Results: Application of Approaches

How frequently are “intelligent” approaches applied?

How much advancement has been made in the last 2 years?

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

% 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

% 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

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

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

Provider Contributions

•  Availability of data •  Availability of models and experience •  Understanding of regulatory perspective •  Technology •  Resource availability

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

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

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

Results: Impact of Outsourcing on Application

Does the outsourcing model make a difference?

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

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

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.

Thank you

Denise Calaprice-Whitty, Ph.D. Senior Consultant The Avoca Group @TheAvocaGroup

Join the conversation #dia2014

24