Industry Efforts
for Ensuring Effective
Oversight in
Outsourced Clinical
Trials
Partnerships in Clinical Trials Conference...
2
Mission: To accelerate the development of best practice
approaches and industry standards for the proactive quality
mana...
3
Avoca Quality Consortium
Industry Participation to Date
4
Avoca Quality Consortium
5
Industry Efforts focused on Oversight
2013 Quality Consortium Leading Practices Focus:
Development of Guidelines and Lea...
6
Avoca Quality Consortium Research on Oversight
7%
59%
30%
4% Executive
Management
Middle
Management
Project
Management
O...
7
Levels of Satisfaction
Sponsor Satisfaction with Clinical Service Providers Work, Value Received,
and Quality Delivered
...
8
Satisfaction with Quality Delivery
Sponsor: Overall, how satisfied are you
with the quality delivered by your
Clinical S...
9
N=249*
16%
76%
8% A higher standard than
that to which in-house
teams are held.
The same standard to
which in-house team...
10
Root causes of quality issues in
outsourced trials
●  Sponsor's inability to provide specifics
about requirements and l...
11
CRO Oversight: Qualitative Data from the CROs’
Perspective
●  Open, honest, and proactive communication
╸ Clear, upfron...
12
Challenges Overseeing CROs: Sponsor
●  Avoiding excessive oversight and micromanagement while
ensuring quality and meet...
13
Consortium Research on Effective Oversight
●  Efficiency in use of resources
●  Definition of roles to minimize duplica...
14
Sponsor: My company
is efficient in the use of resources
applied to the oversight of
outsourced trials.
CRO: The sponso...
15
Representative Verbatim Comment
“[Sponsors] repeat processes outsourced to us as the
CRO...
then drive more resources t...
16
Sponsor: My company
clearly defines the roles of internal
and CRO staff so as
to minimize duplication of effort.
CRO: T...
17
Sponsors
The operational teams involved in
overseeing our CROs consistently
micromanage to ensure that the quality
of d...
18
Sponsors
My company clearly documents CRO
oversight practices, roles, and
responsibilities.
CROs
The sponsors with whic...
19
Sponsors
I personally have received high-quality
deliverables from CROs, even when
overseeing their work at a "strategi...
20
Sponsor: The technology systems used
by my company and its CRO partners
promote efficient oversight practices.
CRO: The...
Quality Consortium
Leading Practice
Initiative Focused on
Oversight
22
Consortium Process for Reviewing Member
Documentation
Tailor
Refine
Combine
Supplement
Member
Reviews
Edit
Adapt
Best
P...
23
And Researched Other External Sources
Internet Searches
Public and Consortia Information
Best Practices from Other Indu...
24
Governance/Organizational Construct
Technical/Project Oversight
Process Oversight
Communication
Metrics/Analytics/Techn...
25
Governance /
Organizational
Construct
Technical /
Project Oversight
Process Oversight
Communication
Oversight
Leadershi...
Thank you!
Partnerships in Clinical Trials Co-presentation with Alan Morgan
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Industry Efforts for Ensuring Effective Oversight in Outsourced Clinical Trials

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Partnerships in Clinical Trials Co-presentation with Alan Morgan

  1. 1. Industry Efforts for Ensuring Effective Oversight in Outsourced Clinical Trials Partnerships in Clinical Trials Conference Vienna, Austria
  2. 2. 2 Mission: To accelerate the development of best practice approaches and industry standards for the proactive quality management of outsourced trials Lead Sponsors and CROs in optimizing their approaches to proactive quality management with an emphasis on bringing them into greater alignment. Avoca Quality Consortium
  3. 3. 3 Avoca Quality Consortium Industry Participation to Date
  4. 4. 4 Avoca Quality Consortium
  5. 5. 5 Industry Efforts focused on Oversight 2013 Quality Consortium Leading Practices Focus: Development of Guidelines and Leading Practices for Effective Oversight Impetus: Common Challenges among Members •  Higher level of scrutiny from regulatory authorities •  Many companies do not have comprehensive, documented process for oversight •  Inefficiency in use of resources with some companies
  6. 6. 6 Avoca Quality Consortium Research on Oversight 7% 59% 30% 4% Executive Management Middle Management Project Management Other 20% 50% 28% 2% Executive Management Middle Management Project Management Operational staff Respondent characteristics •  Total of 476 respondents from 29 companies participated in the 2013 Avoca Quality Consortium Research •  68% response rate Consortium Sponsors: Consortium CROs: N=276 N=200
  7. 7. 7 Levels of Satisfaction Sponsor Satisfaction with Clinical Service Providers Work, Value Received, and Quality Delivered 2% 3% 2% 57% 37% 45% 22% 32% 30% 17% 23% 20% 2% 5% 3% 0% 20% 40% 60% 80% 100% Satisfaction with work done Satisfaction with value received Satisfaction with quality delivered 5 - Very satisfied 4 3 - Neutral 2 1 - Very dissatisfied N 246 239 245
  8. 8. 8 Satisfaction with Quality Delivery Sponsor: Overall, how satisfied are you with the quality delivered by your Clinical Service Providers (including but not limited to CROs)? 2% 45% 30% 20% 3% 17% 70% 10% 3% CRO: Overall, how satisfied are you with the quality that your company delivers for its sponsors? N=245* N=200* 5% 13% 8% 8% 15% 15% 40% 10% 3% 11% 27% 95% 100% 67% 77% 83% 64% 58% 20% 60% 71% 57% 66% 60% 20% 15% 15% 20% 20% 20% 14% 23% 16% 10% 8% 6% 7% 20% 10% 14% 17% 7% 2% 0% 20% 40% 60% 80% 100% A B C D E F G H I J K -All- Very satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied *2013 Avoca Quality Consortium Assessment
  9. 9. 9 N=249* 16% 76% 8% A higher standard than that to which in-house teams are held. The same standard to which in-house teams are held. A lower standard than that to which in-house teams are held. Sponsors: With respect to expectations surrounding quality, my company holds its CROs to… CROs: In general, do you feel that the sponsors with which you work hold your company to a higher standard of quality, the same standard, or a lower standard than that to which they hold their own internal teams? 61% 36% 3% Sponsors hold us to higher quality standards Sponsors hold us to the same quality standards Sponsors hold us to lower quality standards N=200* Standards for Quality Delivered by CROs: Do sponsors hold CROs to a higher standard? *2012 Avoca Quality Consortium Assessment
  10. 10. 10 Root causes of quality issues in outsourced trials ●  Sponsor's inability to provide specifics about requirements and lack of planning ●  Continued push to meet timelines at all costs ●  Sponsors’ decision-Making with impacts on quality (without CRO input) Cited by CROs: ●  Need for better capture and utilization of Lessons Learned ●  Overall poor communication, particularly when it comes to escalation of issues ●  Lack of clarity around expectations and definitions of quality ●  Lack of proactivity Other specific complaints included: ●  The most common complaints had to do with resourcing. ╸ Under-resourcing at CROs ╸ Inexperience and lack of qualifications of CRO staff ╸ Inadequate training ╸ Staff turnover Cited by Sponsors:
  11. 11. 11 CRO Oversight: Qualitative Data from the CROs’ Perspective ●  Open, honest, and proactive communication ╸ Clear, upfront communication of expectations ●  Full transparency – on both sides ╸ Sponsor is fully aware of issues at all times ╸ Sponsor shares all knowledge of past trials ●  Limit micromanagement: Balance between oversight and involvement, delegation and control ●  Ensure there is a solid plan in place at start of project ╸  Roles and responsibilities defined ╸  Agreed definitions of standards ╸  Agreement on expectations What best practices should sponsors adopt?
  12. 12. 12 Challenges Overseeing CROs: Sponsor ●  Avoiding excessive oversight and micromanagement while ensuring quality and meeting timelines ●  Lack of standardization of oversight processes and procedures ╸ Variability with multiple CROs creates challenges due to CRO variations in SOPs and internal processes ●  Budget management: balance of cost and quality Within your company, what are the most significant challenges and issues that you face in overseeing CROs?
  13. 13. 13 Consortium Research on Effective Oversight ●  Efficiency in use of resources ●  Definition of roles to minimize duplication of effort ●  Micromanagement ●  Documentation around roles and responsibilities ●  Overseeing work at a strategic level rather than tactical ●  Use of technology to promote efficient oversight practices Research Pertaining to Oversight - Topics
  14. 14. 14 Sponsor: My company is efficient in the use of resources applied to the oversight of outsourced trials. CRO: The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. N=207 N=128 5% 28% 30% 32% 6% 5% 14% 41% 34% 6% 7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Efficiency in Use of Resources
  15. 15. 15 Representative Verbatim Comment “[Sponsors] repeat processes outsourced to us as the CRO... then drive more resources to discuss and address mismatches at every step instead of just evaluating the quality of the final product.”
  16. 16. 16 Sponsor: My company clearly defines the roles of internal and CRO staff so as to minimize duplication of effort. CRO: The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. N=209 N=127 6% 34% 34% 18% 8% 4% 25% 34% 29% 8% 7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Defining Roles and Responsibilities
  17. 17. 17 Sponsors The operational teams involved in overseeing our CROs consistently micromanage to ensure that the quality of deliverables meets expectations. CROs The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations.7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Prevalence of Micromanagement 21% 30% 34% 11% 4% 8% 46% 32% 11% 3% N=219 N=157
  18. 18. 18 Sponsors My company clearly documents CRO oversight practices, roles, and responsibilities. CROs The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. 7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Documenting Roles 13% 42%21% 20% 4% 5% 33% 34% 23% 5% N=219 N=153
  19. 19. 19 Sponsors I personally have received high-quality deliverables from CROs, even when overseeing their work at a "strategic" rather than detailed level. CROs There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables.7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Overseeing Work at a Strategic Level 5% 35% 34% 18% 8% 4% 22% 29% 29% 16% N=203 N=158
  20. 20. 20 Sponsor: The technology systems used by my company and its CRO partners promote efficient oversight practices. CRO: The technology systems used by my company and its sponsor partners promote efficient oversight practices. N=204 N=136 2% 19% 31% 32% 16% 2% 31% 33% 24% 10% 7% 5% 1% 4% 5% 4% 47% 31% 31% 25% 14% 21% 31% 34% 33% 34% 41% 29% 12% 24% 24% 29% 34% 30% 3% 5% 10% 8% 6% 16% 0% 20% 40% 60% 80% 100% The sponsors with which I work consistently micromanage to ensure that the quality of deliverables meets expectations. The sponsors with which I work clearly document CRO oversight practices, roles, and responsibilities. The technology systems used by my company and its sponsor partners promote efficient oversight practices. The sponsors with which I work clearly define the roles of internal and CRO staff so as to minimize duplication of effort. The sponsors with which I work are efficient in the use of resources applied to the oversight of outsourced trials. There is a direct positive relationship between the intensity of sponsor oversight and the quality of CRO deliverables. 5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree Technology and the Impact on Efficiency
  21. 21. Quality Consortium Leading Practice Initiative Focused on Oversight
  22. 22. 22 Consortium Process for Reviewing Member Documentation Tailor Refine Combine Supplement Member Reviews Edit Adapt Best Practices Concepts Descriptions Details What/How Tools Select Read Interpret Assess Extract Discuss Review Documents Presentations Interviews Meetings Collect
  23. 23. 23 And Researched Other External Sources Internet Searches Public and Consortia Information Best Practices from Other Industries Regulatory Guidance Documents Other Institutional Materials
  24. 24. 24 Governance/Organizational Construct Technical/Project Oversight Process Oversight Communication Metrics/Analytics/Technology Roles/Responsibilities Oversight Leadership Requirements Proactive Risk/Opportunity Management Consortium Guidelines and Tools for Operationalizing Proactive Approaches to Oversight
  25. 25. 25 Governance / Organizational Construct Technical / Project Oversight Process Oversight Communication Oversight Leadership Requirements Metrics / Analytics / Technology Roles / Responsibilities Proactive Risk / Opportunity Management Define Plan Lead Decide Deliver Measure Proactive Quality Management Consortium Guidelines and Tools for Operationalizing Proactive Approaches to Oversight
  26. 26. Thank you!

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