This course is designed for Sponsor and CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. It is a well-documented fact that the current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial (typically 35% of study sites fail to enroll more than 1 participant). Feasibility questionnaires and the current process undertaken by most sponsors and CROs are not effective in predicting site success in implementing a given clinical trial.
This session will challenge the conventional wisdom regarding study feasibility assessment practices. It will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level. Examples of the use of these novel techniques and their excellent results in practice will be provided.
- Evaluate the traditional approach to study feasibility assessment
- Examine what’s working, what’s not, and why not?
- Re-define the concepts of study feasibility at the protocol, country, and site level
- Discuss the purpose and objectives for conducting feasibility assessments
- Explore paradigm shifts in the approach and methods for evaluating study feasibility
- Examine a live demonstration of several new methods, technologies, and approaches
- Discuss case study examples
- Examine real-world examples and return on investment analysis of new approaches
- Evaluate what’s broken in the traditional approach to study feasibility assessments and why
- Identify the characteristics of a high-enrolling site for a given study
- Identify how a protocol can be optimized for enrollment and how the sponsor can maximize enrollment at each site
- Employ practical, statistical, and simulation based methods for country allocation and site selection practices
- Discuss how these novel approaches have translated to improved study performance through real-world case examples
- Directors of Clinical Operations
- Regional Medical Directors
- Clinical Project Managers
- Site Selection Specialists
- Clinical Research Associates (CRAs)
- CRA Managers
Beth D. Harper, BS, MBA
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2 hours; 12:30 - 2:30 p.m. Eastern
June 23, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471