Feasibility: Laying The Foundation for a Successful Clinical Trial

is being presented by Kim Nelson, Director, Global Feasibility Strategy, with PPD and airs on Wednesday, October 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.

By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.

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.