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The basis and success of any drug or device development program is the clinical trial protocol. As the protocol is used to directly inform, instruct, guide, or provide a rationale for nearly all study start-up activities and their work products -- including everything from site identification, feasibility and trial registry filing -- it is critical that protocol development is a well thought out and seamlessly executed process. Knowing how to effectively develop a clinical trial protocol is essential to a compound achieving IRB approval, ensuring the success of the study and ultimately achieving market approval, and there is much variability between companies and individuals on how to optimally approach the development of this critical document. At Barnett/CHI’s forum, stakeholders in the protocol development, clinical operations and compliance arenas will come together to discuss strategies to optimize the overall protocol development process.
Tuesday, October 9
1:00 Welcome & Intro
1:05 Chairperson’s welcome
» FEATURED PRESENTATION
1:15 Writing the Protocol to Achieve the Best Study Outcomes: Linking Objectives to Endpoints
Nariman A. Nasser, CCRP, Director, UCSF Participant Recruitment Service, Clinical & Translational Science Institute University of California, San Francisco
Having clearly defined protocol objectives and endpoints that measure whether the objectives have been met are critical for the success of any clinical trial. Ensuring that the right data is captured over the course of the trial to assess those endpoints starts with protocol development. This session will explore timing and order of protocol sections development, linking objectives to endpoints and procedures so as to effectively capture the right data to achieve those protocol goals.
2:00 Study Design Optimization: The Right Tools, Better Data and Streamlined Processes
Igor Altman, Product Manager, Medidata Solutions
Today’s studies are burdened by overly complex designs and inefficient protocol development processes, resulting in nearly a quarter of all procedures conducted in clinical trials not being associated to primary or secondary endpoints. By leveraging a structured design approach powered by the right tools and data, organizations can reduce study design complexity and drive toward fewer procedures and less data collection without adversely impacting a study’s primary goals.
» CASE STUDY
2:30 Post-Mortem Analyses and Lessons Learned for Avoiding Amendments
Beth Harper, President, Clinical Performance Partners, Inc.
Jane Fang, M.D., M.S., Associate Director, Clinical Informatics, MedImmune
In early 2012, MedImmune undertook an extensive post mortem analysis review of several protocols across different phases and therapeutic areas. The objective was to uncover what could be done during the protocol design, feasibility, and up-front planning stages to avoid amendments. This session will focus on describing the methodology and approach to conducting the post-mortem analysis, and share the findings of the analysis. An interactive discussion will follow to highlight what is currently being done with the results from the analysis to drive process improvements at MedImmune.
3:15 Sponsored Presentation (Opportunity Available; contact Ilana Quigley, email@example.com)
3:30 Refreshment Break with Exhibit Viewing
4:00 Site Training Considerations in Risk-Based Monitoring and Quality Management Systems
Amy Adams, Clinical Project Manager I, Clinical Monitoring Research Program, SAIC-Frederick, Inc.
Denise M. Shelley, M.S., Clinical Project Manager II, Clinical Monitoring Research Program, SAIC-Frederick, Inc.
This presentation will provide an analysis of the data collected from monitoring visits (findings and observations) demonstrating how risk-based monitoring plans are developed and how this data can also be used to develop training to sites on implementing quality systems. With a Risk-Based Monitoring approach there will be a reduction in time that monitors spend at each site and the frequency that they visit each site. In this presentation, we will demonstrate how we develop and execute a risk based monitoring plan based on site observations and findings, then in turn offer a wide variety of training to assist site staff in developing their quality systems approach based on the findings.
» CASE STUDY
4:45 Phone Screen Analytics for Sites
Justin W. Withers, MBA, Director, Clinical Operations, DermResearch, Inc.
Are your phone screeners productive? How do you know? This session will examine phone screening as it relates to clinic scheduling, clinic capacity, no-show rates, projected recruitment, and ultimately, randomization rates. We’ll go over how our site preps for incoming calls, tracks responses, refines our database, evaluates phone screener productivity, and corrects performance.
5:30 Welcome Reception with Exhibit Viewing
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