Best Practice Approaches for Proactive Quality Management
1.
Best Practice Approaches for Proactive Quality
Management
Partnerships in Clinical Trials Latin America
August 14, 2012
2. Partnerships in Clinical Trials Latin America
Best Practice Approaches for Proactive Quality Management
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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3. 2011 Avoca Research: Sponsors’ Satisfaction
Sponsors: Overall Satisfaction with Quality, Service, and Value
N
Satisfaction with "quality"
2% 60% 21% 15% 2% 97
from service providers
Overall satisfaction with work
3% 77% 13% 7% 96
of service providers
Satisfaction with value
1% 51% 34% 14% 88
from service providers
0% 20% 40% 60% 80% 100%
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
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4. Provider Satisfaction: 2011 Avoca Research
Overall, how satisfied have you been with the “quality” that your company has
delivered for its sponsors in the last 3 years?
N
CROs 27% 61% 10% 2%
96
For comparison:
Sponsor satisfaction
2% 60% 21% 15% 2%
with quality from
service providers 97
0% 20% 40% 60% 80% 100%
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
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5. Sponsors: Satisfaction with Quality
On average, how satisfied are you with your CROs’...
N Mean
Compliance with SOPs 90 3.7
and other written procedures
10% 56% 30% 4%
Data quality and integrity 8% 44% 33% 13% 2% 91 3.4
Adequacy of Monitoring Plan 6% 38% 48% 8% 87 3.4
Document control 6% 44% 34% 14% 1% 90 3.4
Audit plans and execution 3% 48% 35% 12% 3% 75 3.4
Monitoring of protocol compliance 3% 48% 31% 13% 5% 87 3.3
Management of protocol compliance 2% 48% 34% 10% 5% 87 3.3
Adherence to Monitoring Plan 3% 38% 37% 22% 87 3.2
0% 20% 40% 60% 80% 100%
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
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6. Sponsors: Satisfaction with Quality
On average, how satisfied are you with your CROs’...
N Mean
Site training 3% 33% 46% 16% 1% 87 3.2
Availability of quality personnel
for my projects
3% 40% 33% 23% 1% 92 3.2
Staff training 3% 35% 44% 16% 2% 89 3.2
Efficiency/timeliness in 92 3.2
achieving clean data
4% 36% 37% 21% 2%
Communications surrounding quality 3% 31% 40% 23% 3% 91 3.1
Governance of quality (e.g. 90 3.0
accountability, management system)
2% 36% 32% 24% 6%
Oversight of third party vendors 77 3.0
(e.g. labs, IVRS vendors, etc.)
1% 34% 34% 27% 4%
0% 20% 40% 60% 80% 100%
Very satisfied Generally satisfied
Neither satisfied nor dissatisfied Generally dissatisfied
Very dissatisfied
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7. 2012 Consortium Assessment: Quality Delivered by CROs
Over the last 3 years, the quality delivered by our CROs has been:
7%
Better than the quality
delivered by our
in-house teams.
The same as the quality
34% delivered by our
in-house (sponsor)
59% teams.
Worse than the quality
delivered by our
in-house teams.
N=167
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8. Causes of Issues with Quality
Causes of Quality Issues in Outsourced Clinical Trials
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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9. 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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10. 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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11. 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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12. 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
Company:
19
31
17
12
10
18
15
33
25
11
22
19
24
10
266
*p<.0001, company effect /
p=ns, function and level effects
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13. Partnerships in Clinical Trials Latin America
The Avoca Quality Consortium
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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14. Partnerships in Clinical Trials Latin America
The Avoca Quality Consortium
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.
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