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Predicting and Preventing Protocol Violations
June 14th, 2007
Dr. Brett Bishop
Executive Director
Operational Strategy & Planning
Covance
Download this Audio Conference (MP3)
Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities, which could help predict and prevent errors. This presentation discussed clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation discussed how clinical trial protocol violations are preventable within a risk management paradigm, and outlined a process for addressing protocol violations using the FMEA approach. Finally, the presentation addressed the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
This audio conference addressed:
- Understanding the main principles of FMEA and how to apply them in an clinical trial setting
- Analyzing the main drivers of clinical trial protocol violations and how to plan around and manage these drivers
- How to recognize early warning signals
- Understanding proactive response strategies to manage the impact of environmental, regulatory and clinical changes
About the speaker:
Dr. Brett Bishop is Executive Director, Operational Planning & Strategy with Covance. He leads a group of key operational professionals in providing relevant data and expertise to project teams and clients in the formulation of strategies for the successful implementation and conduct of Phase II/III clinical trials. Prior to moving into this role, he held several key positions at Covance which included leading clinical operations in both the Asia Pacific region and more recently, across the Americas. He also served as a Client Relationship Director, working globally across all departments as a key advocate for clients and their projects, regardless of therapeutic area or study phase. Dr. Bishop's clinical therapeutic experience includes indications in oncology, immunology, anesthesiology, endocrinology, neurology, cardiovascular and gastrointestinal medicine. Dr. Bishop received his PhD from the University of Auckland and his MSc from the University of Otago.
Who should attend?
- Middle & Senior Management — R&D
- Operations
- Program Management
- Risk Mitigation
- Regulatory
- Medical/Scientific
- Outsourcing/Contracts
Download this Audio Conference (MP3) |
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