Predicting and Preventing Protocol Violations

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 discusses 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 also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation addresses 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.

Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com

Predicting and Preventing Protocol Violations

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 will discuss 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 will examine 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 will look at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation will address 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 event is presented by Brett Bishop of Covance. To learn more, please visit www.fxconferences.com.