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Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing [email protected] ©2013 Industry Standard Research www.ISRreports.com PREVIEW
Risk-based Monitoring: Industry Guidance on
Adoption, Use, and Outsourcing
©2013 Industry Standard Research www.ISRreports.com
PREVIEW
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Report Overview
This report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance on
the adoption, use, and outsourcing of risk-based monitoring.
145pages
78respondents
83 charts and graphs
1. Executive Summary
2. Risk-based Monitoring (RBM) Awareness and Definition
3. Best Practices & Operational Impact of RBM
4. Sponsor Perception and Use of RBM
5. Data and Technology
6. Outsourcing Environment
7. RBM Economics
8. Respondent Demographics
Major Sections:
What you will learn in this report:• Sponsors’ interests in and use of RBM studies, why RBM is gaining momentum, what is driving
adoption, and a high-level look at sponsors’ expected financial and operational outcomes of RBM studies
• Real-world lessons-learned, including advice for individuals and companies wanting to implement RBM studies
• Study types that are seen as most appropriate for RBM and which departments are involved in the planning of these studies
• On-the-ground suggestions for improving the RBM regulatory and training processes
• Which technologies are most important to running a successful RBM-based trial and which are most difficult to implement
• The percentage of RBM studies outsourced, the preferred types of service providers, and most important service provider attributes impacting selection
How you can use this report:For sponsors: Use this information to help drive RBM adoption in your organization, avoid pitfalls that might stagger RBM growth, inform your data infrastructure strategies, and benchmark the use of RBM.
For service providers: Better understand the inner working of sponsors as it relates to the adoption of RBM models and craft better messages and service offerings to account for these views.
Valuable for:Clinical Operations, Medical Directors, R&D Management, Therapeutic Heads, Clinical Service Providers
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Table of Contents
Copyright and Usage Guidelines
Introduction
Methodology
Respondent Demographics and Qualifications
Major Sections
Executive Summary
RBM Awareness and Definition
Familiarity with RBM (before given industry definition)
Familiarity with RBM (after given industry definition)
Respondent-defined definition of RBM
Best Practices & Operational Impact of RBM
Study Characteristics Best Fit for a RBM Study
Preferred phase for risk-based monitoring
Appropriateness of RBM: interventional & non-interventional studies
Roles involved in the risk evaluation/assessment process
Advice for those conducting RBM studies for the first time
Lessons-learned to improve RBM
Improving the regulatory aspects of RBM trials
Improving the monitoring operations/ execution aspect of RBM trials
Relative speed of the pre-trial regulatory trial planning process
Change in the number of planning/ interactions with regulatory bodies
Difficulty training employees in risk-based
monitoring
Top five triggers companies use in risk-based monitoring
Use of specific task forces for RBM
Leading departmental support for RBM
Sponsor Perception and Use of RBM
Riskiness of RBM from an operations and regulatory standpoint
Overall interest in risk-based monitoring
Drivers of RBM interest
Drivers of RBM avoidance
Percent of studies using risk-based monitoring
Cost-benefit of risk-based monitoring
Catalysts for initial RBM use
Adoption momentum of risk-based monitoring
Drivers of RBM momentum
Drivers of RBM losing momentum
Driving adoption of risk-based monitoring
Top barriers while conducting risk-based monitoring
Top reasons that are hindering risk-based monitoring
Top benefits to conducting risk-based monitoring
Centralized monitoring use
Impact of adoption of centralized monitoring on RBM adoption
General opinion of using risk-based monitoring
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Table of Contents
Data and Technology
Most important data-related capabilities
Hardest data-related capability to implement
Most important data components of risk-based monitoring
Recommended technical improvements for RBM studies
Outsourcing Environment
Percent of clinical development outsourced
Percent of clinical monitoring outsourced
Frequency of outsourcing monitoring of RBM studies
Preferred type of service providers
Best type of outsourcing partnership for RBM
Service provider proof-points
Preference between therapeutic vs. RBM vs. data analytics
Important service provider attributes
Use of regulatory consulting service providers
RBM Economics
Save Money With RBM?
Estimated monitoring costs saved using RBM
Investigative sites: risk-level assessment
Clinical studies: risk-level assessment
Respondent Demographics
Company type
Role and responsibility
Primary area of responsibility
Involvement with risk-based monitoring
Past and future use of risk-based monitoring
Job level
Therapeutic area responsibilities
Phase responsibilities
Geography
About Industry Standard Research
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Sample Page: Report Introduction
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www.ISRreports.com ©2013 | 2013 CRO Quality Benchmarking – Phase II/III Service Providers 2
Covance
ICON
INC Research
PAREXEL
PharmaNet/i3
PPD
PRA
Quintiles
Bioclinica
DCRI-Duke
Medpace
Premier Research
RPS
SGS Life Sciences
World Wide Clinical Trials
Minimizing Sta�
TurnoverCRA QualityProject Team
ChemistryTherapeutic
ExpertiseTimely Project
Communications
Commercial Market
Knowledge
Project Manager Quality
Sta� Characteristics
Ratings Key: Clear leadership Better than most About average Falling a bit short
Local Market / Regulatory Knowledge
Figure 1 – “Staff Characteristics” Ratings
Responses have been randomized. Data available in the full report.
© 2013 Industry Standard Research
What’s in a name?
Well, if you ask marketing and branding experts, they will tell you a name can be everything. At ISR, we have found it interesting that someone in the pharmaceutical industry named a process for monitoring investigative sites and patient data “risk-based monitoring.” For an industry that is notoriously risk-averse and highly regulated, we would have bet against a solution named “risk-based monitoring” gaining traction. But it has.
ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on the pharmaceutical industry. First, while it has taken what seems like an eternity, electronic data capture (EDC) technology is now the de facto standard for site/ patient data capture. Second, the patent cliff and declining R&D productivity rates have conspired to “force” pharmaceutical companies to look at ways to cut costs, while increasing efficiency. This has led companies to ask whether 100% source document verification (SDV) is really necessary and whether dispatching throngs of medical monitors has a corresponding positive impact on data quality. Third, regulators have begun to output guidance documents that center on alternative drug development models and processes (risk-based monitoring, adaptive trials, electronic data as source data), making it less risky for sponsors to employ these methodologies/ strategies.
What we learned from the data in this report is that RBM is a process. The awareness of and interest in RBM is relatively high. Sponsors are, or should be, doing their due diligence on the topic. They are looking for both internal subject matter experts across many different disciplines within their organization and for CROs who have experience in not only operationally executing RBM studies, but for CROs who can/ will input on the design and strategies surrounding them.
At this point in the life cycle of RBM, planning is king.
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Sample Pages
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− www.isrreports.com ©2013| Risk-‐based Monitoring Market Assessment 84
3%
6%
38%
44%
9%
0% 15% 30% 45% 60%
Strongly disagree
Disagree
Neither agree or disagree
Agree
Strongly agree
Cost-benefit of r isk-based monitoring
“Using the agree/disagree scale below, please indicate your agreement with the following statement: The overall benefits of risk-based monitoring outweigh the time and resources needed upfront to gain regulatory approval of the protocol and risk-based monitoring plan/strategy?” (Base = 78)
© 2013 Industry Standard Research
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37%
23%
20%
41%
43%
36%
0% 20% 40% 60% 80% 100%
No RBM experience (N=9)
RBM-‐experienced (N=69)
High risk; required more verificaRon/ review
Medium risk; requires moderate verificaRon/ review
Low risk; requires less/ no verificaRon/ review
26%
29%
36%
41%
38%
30%
0% 20% 40% 60% 80% 100%
No RBM experience (N=9)
RBM-‐experienced (N=69)
High risk; required more verificaRon/ review
Medium risk; requires moderate verificaRon/ review
Low risk; requires less/ no verificaRon/ review
Investigative sites: r isk-level assessment
“What percent of your investigative sites fall under the following three levels of risk?”
Clinical studies: r isk-level assessment
“What percent of your studies fall under the following three levels of risk?”
© 2013 Industry Standard Research
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93%
7%
Yes
No
“If it were completely up to you, would you design a study with a risk-based monitoring component?”
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11%
33%
44%
44%
56%
33%
22%
1%
49%
70%
64%
58%
35%
13%
0% 20% 40% 60% 80%
None
Phase IV
Phase IIIb
Phase IIIa
Phase IIb
Phase IIa
Phase I RBM-‐experienced (N=69)
No RBM experience (N=9)
Preferred phase for r isk-based monitoring
“Which phases of clinical development would you recommend your company use for risk-based monitoring? Select all that apply.”
© 2013 Industry Standard Research
© 2013 Industry Standard Research
Data available in full report
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