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Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing

  • June 2013
  • -
  • Industry Standard Research
  • -
  • 145 pages

ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on the pharmaceutical industry. First, 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. 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.

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.

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

Table Of Contents

Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing
Table of Contents

Copyright and Usage Guidelines 4
Introduction 5
Methodology 6
Respondent Demographics and Qualifications 7
Major Sections 9
Executive Summary 11
RBM Awareness and Definition 27
Familiarity with RBM (before given industry definition) 27
Familiarity with RBM (after given industry definition) 28
Respondent-defined definition of RBM 29
Best Practices and Operational Impact of RBM 34
Study characteristics best fit for a RBM study 34
Preferred phase for risk-based monitoring 40
Appropriateness of RBM: interventional and non-interventional studies 41
Roles involved in the risk evaluation/assessment process 43
Advice for those conducting RBM studies for the first time 44
Lessons-learned to improve RBM 48
Improving the regulatory aspects of RBM trials 52
Improving the monitoring operations/ execution aspect of RBM trials 57
Relative speed of the pre-trial regulatory trial planning process 62
Change in the number of planning/ interactions with regulatory bodies 63
Difficulty training employees in risk-based monitoring 64
Top five triggers companies use in risk-based monitoring 65
Use of specific task forces for RBM 72
Leading departmental support for RBM 74
Sponsor Perception and Use of RBM 75
Riskiness of RBM from an operations and regulatory standpoint 75
Overall interest in risk-based monitoring 76
Rationale for being interested in RBM 77
Rationale for non-interest in RBM 81
Percent of studies using risk-based monitoring 83
Cost-benefit of risk-based monitoring 84
Catalysts for initial RBM use 85
Adoption momentum of risk-based monitoring 88
Rationale for gaining momentum 89
Rationale for losing momentum 90
Driving adoption of risk-based monitoring 91
Top barriers while conducting risk-based monitoring 92
Top reasons that are hindering risk-based monitoring 100
Top benefits to conducting risk-based monitoring 101
Centralized monitoring use 109
Impact of adoption of centralized monitoring on RBM adoption 110
General opinion of using risk-based monitoring 111
Data and Technology 112
Most important data-related capabilities 112
Hardest data-related capability to implement 113
Most important data components of risk-based monitoring 114
Recommended technical improvements for RBM studies 116
Outsourcing Environment 120
Percent of clinical development outsourced 120
Percent of clinical monitoring outsourced 120
Frequency of outsourcing monitoring of RBM studies 121
Preferred type of service providers 122
Best type of outsourcing partnership for RBM 123
Service provider proof-points 124
Preference between therapeutic vs. RBM vs. data analytics 129
Important service provider attributes 130
Use of regulatory consulting service providers 131
RBM Economics 132
Save money with RBM? 132
Estimated monitoring costs saved using RBM 134
Investigative sites: risk-level assessment 135
Clinical studies: risk-level assessment 135
Respondent Demographics 136
Company type 136
Role and responsibility 137
Primary area of responsibility 138
Involvement with risk-based monitoring 139
Past and future use of risk based monitoring 140
Job level 141
Therapeutic area responsibilities 142
Phase responsibilities 143
Geography 144
About Industry Standard Research 145

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