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BEST PRACTICES,
®
LLC
Best Practices, LLC Strategic Benchmarking Research
Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies for
Pharmaceutical Success in a Global Marketplace
BEST PRACTICES,
®
LLC
TABLE OF CONTENTS I. Executive Brief, Framework for Clinical, Preparing Clinical, p.2-3
II. Executive Summary
Business Issue and Project Blueprint, p.6-7
Participants, p.8
Key Findings, p.9-12
III. Outside-U.S. Clinical Trial Overview and Insights, p.13-17
IV. Clinical Affairs Budget and FTEs, p. 18-25
V. Clinical Affairs Presence Around the World, p.26-30
VI. Cost and Quality of Outside-U.S. Trials and Outsourcing, p.31-37
VII. Outsourcing Levels for Key Clinical Activities, p.38-47
VIII. Vendor Selection and Outsourcing Attributes, p.48-54
IX. CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 55-64
X. Clinical Affairs Organizational Fit, p.65-72
XI. Outsourcing Success Factors and Pitfalls, p. 73-75
XII. Trends and Directions for Outside-U.S. Trials & Outsourcing, p.76-78
XIII. Appendix, p. 79-81
XIV. About Best Practices, LLC, p.82
BEST PRACTICES,
®
LLC
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Formulate a Strategic Approach for Engaging
Emerging Regions in Clinical Affairs Activities
Business Issue & Objectives
Objectives:
Determine the regions where pharma organizations conduct clinical trials and percent
of patients recruited annually from each region.
Identify which Clinical Affairs activities are best suited to be outsourced or kept in-
house.
Gauge what the experience of pharma organizations has been relative to the cost of
outsourcing clinical trial activities.
Rate the value of benefits associated with outsourcing clinical trial activities.
Best Practices, LLC conducted this benchmarking study to help biopharma organizations set a strategic direction for conducting clinical trial activities in emerging regions of the world.
Field Research & Insight Development:
Survey 7 clinical leaders at 6 pharma companies.
Conduct four executive interviews to collect
qualitative insights from selected survey participants.
INF
OR
M
Objective:
BEST PRACTICES,
®
LLC
Directors &
Senior
Directors
71%
Head of
Clinical
Operations
29%
4
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Pharma Universe of Learning: Leveraging Group Knowledge
(n = 7)
Respondent Job Level
Seven participants from six pharmaceutical companies participated. The study attracted a strong group of experienced pharmaceutical Clinical Affairs executives. Two were at the vice president level and five were at the director level.
Companies
Pharma Segment
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LLC
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Q. What were the approximate total 2010 revenues for your company and the corresponding Clinical
Affairs Spend?
Estimated Revenue
($USD):
Clinical Affairs Spend
($USD):
Clinical Affairs Spend/
Company Revenue:
Max - - -
Mean $14,760,000,000 $460,500,000 7.43%
Median $7,000,000,000 $315,000,000 6.15%
Min - - -
Pharma Segment: Revenue and Clinical Affairs Spend
Pharma Segment: Average Revenue $14B with $460M Clinical Budget
An outlier pushed the pharmaceutical segment’s average Clinical Affairs budget to 7 percent of an organizations total revenues. Due to the outlier effect, a more comparative measure may be the median, which had clinical affairs budget representing 6 percent of organizations’ overall revenues.
(n = 5 4 4)
(Note : able to report mean and median only)
BEST PRACTICES,
®
LLC
Outsourced
60%
Offshored
6%
Insourced
34%
6
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Q. What is the approximate staff sourcing percentage mix of Clinical Trials conducted across your
global enterprise in terms of % In sourced Staffing, % Offshore Staffing, and % Outsourced Staffing
(n = 6)
In sourced
Staffing of
Clinical
Affairs/
Clinical Trials
Offshore
Staffing
Clinical
Affairs/
Clinical Trials
Outsourced
Staffing of
Clinical
Affairs/
Clinical Trials
Max 70% 15% 80%
Mean 34% 6% 60%
Median 30% 5% 60%
Min 15% 0% 30%
Average Staff Sourcing Mix Staff Sourcing Mix Pharma
Pharma Segment: Staff Resourcing Mix
Pharma Segment: Most Trial Staff Outsourced
Pharma participants said 60 percent of their clinical trial staff are outsourced, on average. In-house staff represented only a third of the staff devoted to clinical trials. The pharma sector has seized on use of CROs as a way to reduce long-term clinical costs.
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®
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Q. In general, how do regulatory authorities react to clinical trial data from research conducted
outside the U.S.?
(n = 7)
Few
questions
about data
43%
Extensive
conversations
about data
29%
No
questions
14%
Other
14%
Other:
• “No Phase IV trial
conducted
outside the US
requiring label
change.”
Pharma Segment: Reaction of Regulators to Outside-US Clinical Trial Data
Pharma participants appeared more comfortable with data from trials conducted outside the U.S. Fifty-seven percent of the pharma segment felt regulators had few to no questions about data from outside regions. Still, a third felt the data led to extensive conversations.
Pharma Segment Sees Few to No Questions on Data
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®
LLC
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Q. By clinical affairs activity, note the percent of activities that outsourced and the percent that are
handled in-house (Total of each row = 100%).
Pharma Segment: Outsourced vs. In-house Breakdown Summary
70%
52%
68%
74%
78%
60%
60%
30%
48%
32%
26%
22%
40%
40%
Site Mangement
Data Analysis
Trial Management
Patient Enrollment
Data Management
Investigator
Recruitment
Site Evaluation
Outsourced In-house
Pharma Segment: Clinical Activities Overview Shows Outsourcing a Major Tool for All Key Activities This slide presents an overview of pharma participants’ outsourcing levels for seven key Clinical activities. Participants outsource a majority of the tasks associated with each activity. The activities with the most outsourcing are data management and patient enrollment.
n =
6
6
5
5
5
5
3
BEST PRACTICES,
®
LLC
Highly Inaccurate Somewhat Inaccurate Inconsistent Somewhat Accurate Highly Accurate
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Q. If you outsource, what capabilities are best predictors that the your outsource vendor will
provide a high quality service that meets your expectations:
(n = 5)
Pharma Segment: Predictors of Vendor Quality
Pharma Segment: Staff Experience Best Vendor Predictor
Pharma participants felt that the best quality predictor of an outsourcing vendor was the experience of its staff. The vendor’s track record in the target geography and its staff turn-over rate also were viewed as valuable indicators.
20%
20%
20%
20%
20%
60%
80%
80%
60%
80%
40%
20%
20%
40%
20%Educational credentials
Proven track record in therapeutic
area
Tenure of their staff
Turn-over rates of their staff
Proven track record in the
geography
Experience of staff in relevant areas
BEST PRACTICES,
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Successful CRO has Local Office & Strong Management When considering a CRO for a device trial in an emerging market, two of the most critical traits to look for are 1) Experience in that region and preferably a local office there and 2) Strong management, both at its main office and at the local office in the market where you want to do a trial.
• The CRO should have a main office in your geography so you can
manage them, but CRO also needs to have office in emerging area
so they have local presence. “So they can do the local work but then
we can still drive our timelines and push from here. It’s hard to push a
CRO when you can’t get over to their office quickly – they’re too far
away.”
• The CRO has to have experience in the geographic region
• The CRO has to have people knowledgeable in the management side
of clinical trials and have strong local management as well. “If they
don’t have a strong manager in that local area that knows what it
takes to get clinical trials done, it’s not going to work.”
Don’t…
• Automatically assume a U.S. CRO has a presence in an emerging
market because they say they can work there. That may translate to
we’ll hire another, locally based CRO to do our work.
“We had a CRO running a global
project that did not include Japan
and China – it was a huge project.
That same company was also
helping us run a Japan trial. It was
night and day difference and it
was all because we had very good
management on the global project
and poor management on the
Japan trial.”
– Director, Global Clinical
CRO Dos and Don’ts
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BEST PRACTICES,
®
LLC
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Q. What are the three most valuable lessons learned or critical success factors to make clinical
affairs outsourcing work?
Pharma Segment: Critical Success Factors/Lessons Learned
Pharma: Critical Success Factors/ Lessons Learned
(n = 4)
Pharma participants felt the critical success factors behind successful clinical outsourcing were communication, a dedicated outsourcing group, appropriate oversight and established relationships.
BEST PRACTICES,
®
LLC
About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts
work based on the simple yet profound principle that organizations
can chart a course to superior economic performance by studying
the best business practices, operating tactics and winning
strategies of world-class companies.
Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
www.best-in-class.com
