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Avoca Update:
Managing Risk in
Outsourced
Clinical Trials
Partnerships in Clinical Trials Meeting
2
Patricia Leuchten (Moderator)
CEO, The Avoca Group
Coleen Glessner
VP & Head of Clinical Trial Process & Quality
Pfizer
...
3
2013 Avoca Research: Overview
Objective of 2013 Research
Comprehensive assessment of the
way risk is managed in the
cond...
4
2013 Avoca Research: Overview
Questions Explored
●  Risk-sharing models:  What kinds of models are most often used?  Und...
5
2013 Avoca Research: Overview
234 Respondents
●  Sponsors: 113 Respondents
╸ Approximately half in top 20 in terms of re...
Risk Sharing
Sponsor and
Service Provider
Results
7
Risk-sharing between Sponsors and
Providers
Types of Risk-sharing
●  Provider bonuses for achieving milestones and targe...
8
Sponsors’ Experience with Risk-sharing
When providers
receive rewards
for performance,
most sponsors
report a mix of
pos...
9
CROs’ Experience with Risk-sharing
And CROs
report similar
experiences:
	
  
	
  Penalties
generally
lead to more
negati...
10
Comments on Experiences
“These relationships require absolute clarity in roles and responsibilities and up-
front plann...
11
Comments on Experiences
“Increased work/revenue stream in return for quality deliverables is a good
motivator. With bon...
Risk Assessment,
Risk Management,
and Risk-based
Monitoring
13
Prevalence of Systematic, Formal Risk
Assessments
38%
18%
16%
14%
14%
For >75% of
outsourced
clinical trials
For 51% - ...
14
N=40
Review by Regulatory Authorities
Have your approaches to risk assessment and
management been reviewed by any regul...
15
N=50
Use of Risk-related information to
determine levels of CRO oversight
24%
22%
20%
14%
20%
For >75% of
clinical tria...
16
8%
9%
75%
73%
40%
57%
70%
8%
9%
50%
43%
30%
8%
9%
10%
0% 20% 40% 60% 80% 100%
For >75%
For 51% - 75%
For 25% - 50%
For ...
17
What risks are assessed?
	
  
	
  
	
  	
  
When a systematic
assessment is conducted,
the following risks are
typicall...
18
Are risk-based approaches leading to
greater efficiency and higher quality?
While not all are
seeing the more
efficient...
19
Are risk-based approaches leading to
greater efficiency and higher quality?
	
  
While not all
are seeing the
more effi...
20
Satisfaction Rates of Specific Variables Related to Risk
Management
Sponsor respondents surveyed are,
on average, more ...
21
N=45
Prevalence of use of Risk-based Monitoring
18%
16%
4%
29%
33%
For >75% of
clinical trials
For 51% - 75%
of clinica...
22
Opportunities to Enhance Understanding
How would you rate your understanding of best practices in risk
assessment and m...
Thank you!
Managing Risk in Outsourced Clinical Trials
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Managing Risk in Outsourced Clinical Trials

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Avoca Update: Managing Risk in Outsourced Clinical Trials

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Managing Risk in Outsourced Clinical Trials

  1. 1. Avoca Update: Managing Risk in Outsourced Clinical Trials Partnerships in Clinical Trials Meeting
  2. 2. 2 Patricia Leuchten (Moderator) CEO, The Avoca Group Coleen Glessner VP & Head of Clinical Trial Process & Quality Pfizer Jamie Macdonald CEO, INC Research Patrick Nealon Senior Director Clinical Operations Millennium the Takeda Oncology Company Panel Members
  3. 3. 3 2013 Avoca Research: Overview Objective of 2013 Research Comprehensive assessment of the way risk is managed in the conduct of clinical studies.
  4. 4. 4 2013 Avoca Research: Overview Questions Explored ●  Risk-sharing models:  What kinds of models are most often used?  Under what circumstances?   What are the magnitudes of the incentives/ penalties?  Have the incentives been successful?   Is the success realized mostly in time, cost, or quality?  What have been the downsides? ●  Risk assessment: How is it conducted?   Are assessments just qualitative or also quantitative?  Has it been successful or not?  In what ways? ●  Risk-based management approaches:  To what tasks have such approaches been applied?   Have the approaches used quantitative modeling or have they been qualitative?   Have they been successful?  If so, how is success realized? What have been the downsides?  How is this work viewed by regulators?
  5. 5. 5 2013 Avoca Research: Overview 234 Respondents ●  Sponsors: 113 Respondents ╸ Approximately half in top 20 in terms of revenue o  66% Pharma o  26% Biotech o  5% Device o  3% Combination/Other ●  Clinical Service Providers: 124 Respondents ╸ 60% in top 20 in terms of revenue o  86% CROs o  11% Niche o  3% Laboratories
  6. 6. Risk Sharing Sponsor and Service Provider Results
  7. 7. 7 Risk-sharing between Sponsors and Providers Types of Risk-sharing ●  Provider bonuses for achieving milestones and targets ●  Provider penalties for missing milestones and targets ●  Guarantees of continued work/revenue stream in exchange for provider commitments ●  Provider stake in outcome of study (e.g., company stock)
  8. 8. 8 Sponsors’ Experience with Risk-sharing When providers receive rewards for performance, most sponsors report a mix of positive and negative experiences     However, when providers are penalized, experiences have been   more negative.  
  9. 9. 9 CROs’ Experience with Risk-sharing And CROs report similar experiences:    Penalties generally lead to more negative experiences.   54% of sponsors and 58% of providers were most likely to have had “primarily positive” experiences with guarantees of continued work/ revenue stream in exchange for provider commitments.
  10. 10. 10 Comments on Experiences “These relationships require absolute clarity in roles and responsibilities and up- front planning assumptions that we have not always had, which has caused difficulties along the way.” “The inclusion of provider bonuses and penalties has had a detrimental affect on study team morale. OK when the target has been reached outright, but lots of 'extra' negotiating when a negative outcome.” Sponsors:
  11. 11. 11 Comments on Experiences “Increased work/revenue stream in return for quality deliverables is a good motivator. With bonuses and penalties a great deal of time can be wasted attributing blame rather than focusing on timely high quality delivery.” Providers:
  12. 12. Risk Assessment, Risk Management, and Risk-based Monitoring
  13. 13. 13 Prevalence of Systematic, Formal Risk Assessments 38% 18% 16% 14% 14% For >75% of outsourced clinical trials For 51% - 75% of outsourced clinical trials For 25% - 50% of outsourced clinical trials For 1% - 24% of outsourced clinical trials Never N=50 39% 19% 26% 13% 3% N=31 Sponsors CROs Most sponsors and clinical service providers reported that a systematic risk assessment process was used for the majority of their clinical trials, whether in-house or outsourced.
  14. 14. 14 N=40 Review by Regulatory Authorities Have your approaches to risk assessment and management been reviewed by any regulatory authority? 73% 27% Positively Neutrally If "Yes", how were they viewed by the regulatory authority? N=11 Sponsors N=34 80% 20% Positively Neutrally N=10 CROs 25% 75% Yes No 29% 71% Yes No Majority report that approaches to risk assessment and management are viewed favorably by Regulatory Authorities.
  15. 15. 15 N=50 Use of Risk-related information to determine levels of CRO oversight 24% 22% 20% 14% 20% For >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trials For 1% - 24% of clinical trials Never How often do your teams use risk-related information to determine the level and/or type of sponsor oversight that you will employ for your CRO partners? For over 50% of clinical trials, almost half (46%) of sponsor respondents use risk-related information to determine level of oversight
  16. 16. 16 8% 9% 75% 73% 40% 57% 70% 8% 9% 50% 43% 30% 8% 9% 10% 0% 20% 40% 60% 80% 100% For >75% For 51% - 75% For 25% - 50% For 1% - 24% Never Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied How often do your teams use risk-related information to determine the level and/or type of sponsor oversight that you will employ for your CRO partners? N 12 11 10 7 10 Sponsors who use risk information to determine oversight levels tend to be more satisfied with CRO performance. Overall Sponsor Satisfaction (by use of risk-related information to determine levels of CRO oversight)
  17. 17. 17 What risks are assessed?         When a systematic assessment is conducted, the following risks are typically formally assessed (by more than half the sample): •  Patient enrollment risks •  Vendor performance risks •  Data quality risks •  Other timeline risks •  Site compliance risks •  Cost risks •  Clinical trial subject safety risks •  Drug/device supply related risks  
  18. 18. 18 Are risk-based approaches leading to greater efficiency and higher quality? While not all are seeing the more efficient use of resources through risk assessment and management approaches… …most sponsors ARE seeing increased quality, at least sometimes.  
  19. 19. 19 Are risk-based approaches leading to greater efficiency and higher quality?   While not all are seeing the more efficient use of resources through risk assessment and management approaches… …most sponsors ARE seeing increased quality, at least sometimes.  
  20. 20. 20 Satisfaction Rates of Specific Variables Related to Risk Management Sponsor respondents surveyed are, on average, more satisfied with in- house teams compared to CROs and other service providers on a number of points including: •  Proactive identification of risks •  Communications regarding risk-related trial information •  Frequency of review of risk- related trial information. Sponsor respondents rate CRO performance, on average, lower than CROs rate themselves.
  21. 21. 21 N=45 Prevalence of use of Risk-based Monitoring 18% 16% 4% 29% 33% For >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trials For 1% - 24% of clinical trials Never How often do your project/program teams use a risk-based approach to the monitoring of Investigative Sites for outsourced clinical trials? 18% 20% 15% 29% 18% N=34 Sponsors CROs Sponsors and CROs were divided in their reported use of risk-based monitoring.
  22. 22. 22 Opportunities to Enhance Understanding How would you rate your understanding of best practices in risk assessment and management in clinical trials? (Sponsor Data) 38% 13% 9% 23% 54% 36% 31% 23% 45% 8% 10% 9% 0% 20% 40% 60% 80% 100% Executive Management Middle Management Project Management Very strong understanding Good understanding Fair understanding Poor understanding N 13 39 11 While executives generally reported a strong understanding, operational teams may benefit from more training.
  23. 23. Thank you!

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