Best Practice Approaches for Proactive Quality Management Partnerships in Clinical Trials Latin America August 14, 2012

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Best Practice Approaches for Proactive Quality Management

Partnerships in Clinical Trials Latin America

u Specific topics

u Differences in perceptions between sponsors and CROs regarding the quality of outsourced trials

u Best practice approaches

u  Industry Consortium focused on creating standards and bridging gaps between sponsors and CROs

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N

97

96

88

2%

3%

1%

60%

77%

51%

21%

13%

34%

15%

7%

14%

2%

0% 20% 40% 60% 80% 100%

Satisfaction with "quality" from service providers

Overall satisfaction with work of service providers

Satisfaction with value from service providers

Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied

Sponsors: Overall Satisfaction with Quality, Service, and Value

2011 Avoca Research: Sponsors’ Satisfaction

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N

96

97

27%

2%

61%

60%

10%

21%

2%

15% 2%

0% 20% 40% 60% 80% 100%

CROs

For comparison: Sponsor satisfaction with quality from service providers

Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied

Overall, how satisfied have you been with the “quality” that your company has delivered for its sponsors in the last 3 years?

Provider Satisfaction: 2011 Avoca Research

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On average, how satisfied are you with your CROs’...

10%

8%

6%

6%

3%

3%

2%

3%

56%

44%

38%

44%

48%

48%

48%

38%

30%

33%

48%

34%

35%

31%

34%

37%

4%

13%

8%

14%

12%

13%

10%

22%

2%

1%

3%

5%

5%

0% 20% 40% 60% 80% 100%

Compliance with SOPs and other written procedures

Data quality and integrity

Adequacy of Monitoring Plan

Document control

Audit plans and execution

Monitoring of protocol compliance

Management of protocol compliance

Adherence to Monitoring Plan

Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied

N Mean 90 3.7

91 3.4

87 3.4

90 3.4

75 3.4

87 3.3

87 3.3

87 3.2

Sponsors: Satisfaction with Quality

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On average, how satisfied are you with your CROs’...

3%

3%

3%

4%

3%

2%

1%

33%

40%

35%

36%

31%

36%

34%

46%

33%

44%

37%

40%

32%

34%

16%

23%

16%

21%

23%

24%

27%

1%

1%

2%

2%

3%

6%

4%

0% 20% 40% 60% 80% 100%

Site training

Availability of quality personnel for my projects

Staff training

Efficiency/timeliness in achieving clean data

Communications surrounding quality

Governance of quality (e.g. accountability, management system)

Oversight of third party vendors (e.g. labs, IVRS vendors, etc.)

Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied

N Mean

87 3.2

92 3.2

89 3.2

92 3.2

91 3.1

90 3.0

77 3.0

Sponsors: Satisfaction with Quality

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N=167

7%

34%

59%

Better than the quality delivered by our in-house teams.

The same as the quality delivered by our in-house (sponsor) teams.

Worse than the quality delivered by our in-house teams.

Over the last 3 years, the quality delivered by our CROs has been:

2012 Consortium Assessment: Quality Delivered by CROs

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Causes of Quality Issues in Outsourced Clinical Trials

Causes of Issues with Quality

u  Key themes

u  Inability of clinical service providers to consistently perform to their potential due to constraints placed by sponsors:

n  Costs

n  Processes/procedures

n  Timelines

n  Decision-making (including about site inclusion/closure)

n  Lack of expectation-setting

u  Cost pressures on the industry

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Partnerships in Clinical Trials Latin America

Question: What practices are being followed by those that are

most satisfied with their CROs’ performance?

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Partnerships in Clinical Trials Latin America

Answer: The companies that are adept at defining

expectations for quality and those that have robust systems for measuring quality.

u  Use of written Quality Agreements:

u  94% of sponsors who use written Quality Agreements are satisfied, as opposed to 59% of those who do not use written Quality Agreements

u  Use of adequate metrics:

u  94% of sponsors who use adequate metrics are satisfied, as opposed to 64% of those who do not use adequate metrics

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Use of Quality Agreements: 2012 Consortium Assessment

How often do your teams use written Quality Agreements to establish and document quality expectations in outsourced clinical trials?

N=266

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How often do your teams use written Quality Agreements to establish and document quality expectations in outsourced clinical trials?*

Use of Quality Agreements: 2012 Consortium Assessment

*p<.0001, company effect / p=ns, function and level effects

Com

pany

: N 19 31 17 12 10 18 15 33 25 11 22 19 24 10 266

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The Avoca Quality Consortium

Partnerships in Clinical Trials Latin America

Goals

u  Short-term: Creation of standards for Quality Management with a focus on developing definitions for quality and standards for measuring quality (Quality Agreements and Quality Metrics)

u  Long-term: Develop a new paradigm in the approach to proactive quality management and partnering with CROs to ensure high quality and mitigate risk

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The Avoca Quality Consortium

Partnerships in Clinical Trials Latin America

Corporate sponsors:

Pharma and Biotech members include: •  Alexion Pharmaceuticals, Amgen, Astellas Pharma, AstraZeneca, Biogen Idec, Bristol-Myers

Squibb, Cerexa, Cubist Pharmaceuticals, Eli Lilly and Company, GlaxoSmithKline, Grünenthal, ImClone Systems, Janssen Research & Development, Otsuka, Pfizer, Purdue and Roche.

CRO members include:

•  Chiltern International, Covance, INC Research, ICON, Harrison Clinical Research, PAREXEL International, PharmaNet/i3, PRA International, Quintiles, Theorem Clinical Research and RPS.

  Thank you!