RISK-BASED MONITORING: THE GOOD, THE BAD AND THE UGLY

Transcription

1 RISK-BASED MONITORING: THE GOOD, THE BAD AND THE UGLY Outsourcing in Clinical Trials Canada 2015 October 28, 2015 Kara Lee McWatters Project Management Stiris Research Inc.

2 AGENDA What is Risk-Based Monitoring (RBM)? RBM: The Stiris Experience Learnings- the good, bad and ugly Strategies for improving and implementing a RBM program

3 WHAT IS RISK-BASED MONITORING (RBM) Also Known As (AKA): Targeted Monitoring (%, specific fields) Centralized Monitoring (trends, listings review) Remote Monitoring (CRA review)

4 WHY USE A RBM APPROACH? FDA Guidance of August 2013 reinforces support of RBM 1 Advantages Cost-savings of 15-20% 2 as a result of less frequent on-site monitoring visits and reduced source document verification Average % of SDV queries generated by monitoring 7.8%(2.4% in critical data) 3 Quicker completion of studies=quicker to market Lower cost and similar quality?? Only 33% of CROs and 23% of pharmaceutical companies always use a centralized monitoring process to guide, target or supplement on-site visits 4 89% of CROs and 94% of pharmaceutical companies always perform on-site monitoring visits 5

5 RBM- THE STIRIS EXPERIENCE Designed and/or implemented risk-based monitoring programs in 2 North American clinical trials Managed transition from conventional monitoring to RBM Large (70 sites) and small (12 sites) study experience Studies with slow and rapid recruitment

6 LESSONS LEARNED - THE GOOD Weekly review of specific site metrics allowed for rapid identification of current and potential issues Quicker resolution of issues versus conventional monitoring Reduced time on site- focused monitoring Regular/frequent site communication Effective use of CRA time/expertise

7 LESSONS LEARNED - THE BAD AND THE UGLY Investigators must be available when CRAs are onsite. Investigators and site staff must take responsibility for the quality of the data entered. Increase in responsibilities of PI and study coordinator (already overburdened with other trials-investigators expected them to spend more time on their studies than allotted 5,6) Loss of personal touch- reliance on information systems and technology

8 No. of Respondents SITE SURVEY 6 What is your overall satisfaction level with risk-based monitoring? Clinical Study Coordinator/Clinical Research Nurse Clinical Research Associate/Study Monitor (Independent, Pharmaceutical or Contract Research Organization) Satisfied Needs improvement Not satisfied 0 Unacceptable

9 SITE SURVEY 6 Are you confident that the quality of data is equivalent to that of conventional monitoring? Clinical Research Associate/Study Monitor (Independent, Pharmaceutical or Contract Research Organization) Clinical Study Coordinator/Clinical Research Nurse 0 Strongly agree or agree Neither agree nor disagree Strongly disagree or disagree

10 SITE SURVEY 6 Has risk-based monitoring impacted the Study Coordinator/Research Nurse s responsibilities? Clinical Study Coordinator/Clinical Research Nurse 0 Clinical Research Associate/Study Monitor (Independent, Pharmaceutical or Contract Research Organization)

11 Administrative responsibilities (regulatory documents processing/filing/copying) Data management (data entry/query resolution) Investigational Product management SITE SURVEY 6 If you answered significantly increased or slightly increased, what areas have increased in responsibility? Clinical Study Coordinator/Clinical Research Nurse Clinical Research Associate/Study Monitor (Independent, Pharmaceutical or Contract Research Organization) 0

12 No. of Respondents SITE SURVEY 6 The role of the Clinical Research Associate has transitioned to that of a trainer and site manager Clinical Study Coordinator/Clinical Research Nurse 10 5 Clinical Research Associate/Study Monitor (Independent, Pharmaceutical or Contract Research Organization) 0 Agree Disagree P=0.023

13 STRATEGIES FOR IMPROVING AND IMPLEMENTING A RBM PROGRAM Use experienced CRAs/mentor less experienced CRAs Determine the critical data points Determine those that require on-site verification/discuss the consequences/risks of not verifying them Determine expectations for on-site versus centralized review Update/create the monitoring plan Create the tools

14 STRATEGIES FOR IMPROVING AND IMPLEMENTING A RBM PROGRAM CRAs Change management- CRA as a site manager and educator Training and mentoring Provide tools for on-site and remote monitoring Leveraging information technology and making it meaningful Moving the pegs forward, week to week instead of visit to visit Sites Change management- CRA/site partnership and changing responsibilities Training and mentoring Leveraging information technology- meaningful but not overwhelming Regular, effective communication

15 THANK YOU! Kara Lee McWatters Project Management Stiris Research Inc.

16 REFERENCES 1 United States Food and Drug Administration (2013). Guidance for Industry: Oversight of Clinical Investigations- A Risk-Based Approach to Monitoring [Online]. Available at: (Accessed: 20 Sep 2013) 2 PriceWaterhouseCoopers (2013). Risk-based monitoring- Reduce clinical trial costs while protecting safety and quality [Online]. Available at: (Accessed: 18 Jun 2013) 3 TransCelerate Biopharma Inc. (2013). Position Paper: Risk-Based Monitoring Methodology [Online]. Available at: 4 Morrisson, B.W. (2011). Monitoring the quality of conduct of clinical trials: a survey of current practices [Online]. Available at: (Accessed: 2 July 2013) 5 Speicher, L.A. (2011). The Critical Need for Academic Health Centers to Assess the Training, Support and Career Development Requirements of Clinical Research Coordinators: Recommendations From the Clinical and Translational Science Award Research Coordinator Taskforce [Online]. Available at: %20for%20Acad%20Med%20Nov% pdf (Accessed: 18 Jun 2013) 6 MCWATTERS, K. (2014). The Impact Of Risk-based Monitoring On Resource Utilization Of Clinical Trial Research Site Staff At Canadian Cancer Centres: A Comparison Of Site And Clinical Research Associate (CRA) Perspectives. M.SC. DISSERTATION, UNIVERSITY OF LIVERPOOL.