partnerships in clinical trials co-presentation with alan morgan

Industry Efforts for Ensuring Effective

Oversight in Outsourced Clinical

Trials

Partnerships in Clinical Trials Conference Vienna, Austria

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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

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Avoca Quality Consortium Industry Participation to Date

4

Avoca Quality Consortium

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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

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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

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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

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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

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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

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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:

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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?

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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?

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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

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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

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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.”

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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%









deliverables.


Defining Roles and Responsibilities

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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%









deliverables.


Prevalence of Micromanagement

21%

30% 34%

11% 4% 8%

46% 32%

11% 3%

N=219 N=157

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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%









deliverables.


Documenting Roles

13%

42% 21%

20%

4% 5%

33%

34%

23%

5%

N=219 N=153

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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%









deliverables.


Overseeing Work at a Strategic Level

5%

35%

34%

18%

8% 4%

22%

29%

29%

16%

N=203 N=158

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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%









deliverables.


Technology and the Impact on Efficiency

Quality Consortium Leading Practice

Initiative Focused on Oversight

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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

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And Researched Other External Sources

Internet Searches

Public and Consortia Information

Best Practices from Other Industries

Regulatory Guidance Documents

Other Institutional Materials

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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

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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

Thank you!

partnerships in clinical trials co-presentation with alan morgan

Health & Medicine

higher standard of quality

consortium cros

quality delivery sponsor

lower quality standards

root causes of quality

cro oversight

multiple cros

cros inexperience