MCC Industry Practices Insight Reports

An Updated Look at Risk Assessment and Risk-based Management Practices

A Survey of Risk Assessment Practices and a Review of Current Organizational Approaches and e-Data Sources Driving Risk-based Monitoring Programs

The clinical trials industry has seen Risk-Based Monitoring (RBM) move from conception to vanguard over the past decade. This change in acceptance of RBM is a key finding in an online survey conducted by Metrics Champion Consortium (MCC) between November 2015 and January 2016. The survey is a follow-up to the seminal work piloted by MCC in 2013, which was the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.

That earlier research documented the widespread use of RBM across all phases of trials, in all regions, on a pilot basis as well as across programs, and in pivotal trials. Specifically, in 2013, 30% of respondents reported using RBM in pivotal trials. Now, two years later, the updated survey finds that 50% of respondents are using RBM in pivotal trials, a significant shift. In addition, this report delves into how RBM approaches have evolved, the characteristics of those approaches, the types of studies in which each RBM approach is applied, reasons behind implementation of RBM programs, and the central data analytic methods being used.

New questions explore risk assessment practices and RBM program effectiveness metrics. The survey questionnaire was updated to explore the industry’s growing use of formal risk assessment (RA) as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial and as it unfolds. Additionally, new questions gathered feedback about how company assesses (or plans to assess within a year) the effectiveness of their RBM programs.

Key Questions Explored In This Study

Section I: Risk Assessment
  • Are Organizations Conducting Formal Risk Assessments?
  • What Electronic Data Sources Do Organizations Review During Risk Assessments?
  • Why Do Organizations Conduct Risk Assessments?
Section II: Risk-based Site Monitoring
  • How Many Organizations Use a Risk-Based Approach to Site Monitoring?
  • In Which Study Phases Do Organizations Operate a Risk-Based Approach to Monitoring?
  • In Which Regions of the World Do Organizations Operate a Risk-Based Approach to Monitoring?
  • How Do Organizations Approach the Study Monitoring Process?
  • What Strategies Are Used for Reduced SDV and other Risk-based On-Site Monitoring?
  • Why Do Organizations Implement a Risk-Based Approach to Monitoring?
  • Which Electronic Data Sources Do Organizations use?
  • Which Analysis Methods Do Organizations?
  • How Do Organizations Assess the Effectiveness of RBM Programs?

The survey contained 28 questions and represents the experiences of nearly 70 respondents at pharmaceutical, contract research organizations (CRO), biotechnology, medical device, academic research, and other institutions. The rich data gathered in the survey are presented in more than 50 charts and graphs.

Table of Contents

  • Executive Summary
  • RBM Models, Approaches and Definitions
  • Survey Methodology
  • Section I: Risk Assessment Results
  • Section II: Risk-based Site Monitoring Results
  • Conclusion


List of Figures

  • Table 1: Summary of survey questions and findings
  • Figure 1: Risk-based monitoring program characteristics described in 2013 & 2015 survey
  • Figure 2: Central data analytic approaches described in 2013 & 2015 surveys
  • Figure 3: Remote monitoring approaches described in the 2013 & 2015 surveys
  • Figure 4: On-site monitoring approaches described in the 2013 & 2015 surveys
  • Table 2: Overview of survey methodology
  • Figure 5: Profile of Respondents by Organization Type [2015]
  • Figure 6: Profile of Respondents by Organization Type (2013 compared to 2015)
  • Figure 7: Profile of Respondents by Organization Size [2015]
  • Figure 8: Companies conducting or planning to conduct formal assessments of project/protocol-level risk prior to study conduct by organization size [2015]
  • Figure 9: Companies conducting or planning to conduct formal assessments of project/protocol-level risk prior to study conduct by organization type [2015]
  • Figure 10: Companies conducting or planning to conduct repeat formal assessments of project/protocol-level risk during study conduct by organization size [2015]
  • Figure 11: Companies conducting or planning to conduct repeat formal assessments of project/protocol-level risk during study conduct by organization type [2015]
  • Figure 12: Companies conducting or planning to conduct and repeat formal assessments of project/protocol-level risk by organization size [2015]
  • Figure 13: Electronic data sources organizations review/plan to review during risk assessments [2015]
  • Figure 14: Electronic data sources small organizations review/plan to review during risk assessments [2015]
  • Figure 15: Electronic data sources medium organizations review/plan to review during risk assessments [2015]
  • Figure 16: Electronic data sources large organizations review/plan to review during risk assessments [2015]
  • Figure 17: Reasons organizations conduct/plan to conduct risk assessments [2015]
  • Figure 18: Reasons organizations conduct/plan to conduct risk assessments by organization size [2015]
  • Figure 19: Utilization of risk-based monitoring approaches by organization size [2015]Figure 20: Utilization of risk-based monitoring approaches by organization type [2015]
  • Figure 20: Figure 20: Utilization of risk-based monitoring approaches by organization type [2015]
  • Figure 21: Utilization of risk-based monitoring approaches by study phase [2015]
  • Figure 22: Utilization of risk-based monitoring approaches by study phase [2013-2015]
  • Figure 23: Utilization of risk-based monitoring approaches by global region [2015]
  • Figure 24: Comparison of utilization of risk-based monitoring approaches by global region [2013 – 2015]
  • Figure 25: Onsite, Remote & Central Analytics monitoring practices [2015]
  • Figure 26: Onsite, Remote & Central Analytics monitoring practices among small organizations [2015]
  • Figure 27: Onsite, Remote & Central Analytics monitoring practices among medium
  • Figure 28: Onsite, Remote & Central Analytics monitoring practices among large organizations [2015]
  • Figure 29: Study monitoring approaches organizations utilize/plan to utilize [2015]
  • Figure 30: Study monitoring approaches small organizations utilize/plan to utilize [2015]
  • Figure 31: Study monitoring approaches medium organizations utilize/plan to utilize [2015]
  • Figure 32: Study monitoring approaches large organizations utilize/plan to utilize [2015]
  • Figure 33: Comparison of study monitoring approaches organizations utilize/plan to utilize [2013 to 2015]
  • Figure 34: Remote site monitoring strategies organizations utilize [2015]
  • Figure 35: Comparison of remote site monitoring approaches organizations utilize [2013 to 2015]
  • Figure 36: Remote site monitoring communication channels [2015]
  • Figure 37: Comparison of remote site monitoring communication channels [2013 to 2015]
  • Figure 38: Reduced SDV & other risk-based onsite monitoring strategies organizations use/plan to use [2015]
  • Figure 39: Reduced SDV & other risk-based onsite monitoring strategies small organizations use/plan to use [201]
  • Figure 40: Reduced SDV & other risk-based onsite monitoring strategies medium organizations use/plan to use [2015]
  • Figure 41: Reduced SDV & other risk-based onsite monitoring strategies large organizations use/plan to use [2015]
  • Figure 42: Comparison of reduced SDV & other risk-based onsite monitoring strategies organizations use/plan to use [2013 to 2015]
  • Figure 43: Comparison of reasons for implementing RBM [2013 to 2015]
  • Figure 44: Reasons for implementing RBM by organization size [2015]
  • Figure 45: Electronic data sources used in central monitoring and/or remote site monitoring [2015]
  • Figure 46: Comparison of electronic data sources used in central monitoring and/or remote site monitoring [2013 to 2015]
  • Figure 47: Electronic data sources used in risk assessment (RA) compared to central monitoring and/or remote site monitoring (RBM) [2015]
  • Figure 48: Data analytic approaches used in central monitoring [2015]
  • Figure 49: Comparison of data analytic approaches used in central monitoring [2013 to 2015]
  • Table 3: Types of metrics organizations use to assess RBM programs [2015]
  • Figure 50: Top ten metrics organizations use to assess RBM programs success [2015]
  • Figure 51: Time and cost metrics organizations use to assess RBM programs success [2015]
  • Figure 52: Efficiency and quality metrics organizations use to assess RBM programs success [2015]
  • Figure 53: Relationship and monitoring action item metrics organizations use to assess RBM programs success [2015]
  • Figure 54: MCC’s risk-based monitoring road map
Report cover

Pricing:

MCC members are eligible to receive a 20% discount rate on this report. Please use the discount code available on the MCC Member Homepage or contact MCC to obtain the code.

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