Managing Risk in Outsourced Clinical Trials

Avoca Update:

Managing Risk in Outsourced Clinical Trials

Partnerships in Clinical Trials Meeting

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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

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2013 Avoca Research: Overview

Objective of 2013 Research

Comprehensive assessment of the

way risk is managed in the conduct of clinical studies.

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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?

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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

Risk Sharing

Sponsor and Service Provider

Results

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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)

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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.

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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.

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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:

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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:

Risk Assessment, Risk Management,

and Risk-based Monitoring

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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.

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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

Spo

nso

rs

N=34

80%

20% Positively

Neutrally

N=10 CRO

s

25%

75%

Yes

No

29%

71%

Yes No

Majority report that approaches to risk assessment and management are viewed favorably by Regulatory Authorities.

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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



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

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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)

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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

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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.

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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.

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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.

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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.

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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

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While executives generally reported a strong understanding, operational teams may benefit from more training.

Thank you!

Managing Risk in Outsourced Clinical Trials

Health & Medicine

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