Best Practices for Clinical Trial Site Selection - Finding High-Enrolling, High-Data Quality Producing Sites
Thursday, February 13, 2014 from 10:00 AM to 11:30 AM (PST)
This clinical compliance training will provide attendees best practices for clinical trial site selection. Attendees will learn how to identify high-quality and low-quality data sites and how to address issues in both of those scenarios.
Why Should You Attend:
Clinical trial site enrollment rate is often the leading factor in determining study length and associated costs with getting product to the market. Most large-scale trials involve a typical ratio of 25% of sites enrolling 75% of the study subjects, 25% enroll no subjects, and the remaining 50% enroll the remainder of subjects. With limited budgets and timelines, there are proven methods which virtually eliminate the non-enrolling sites and move them to high or near-high enrolling sites, which is crucial when there is a limited number of sites to work with due to budgetary and other constraints. With estimated start-up costs currently averaging $30,000 per site, it is crucial that high-enrolling, high-quality sites are selected. This process works for both trials run completely within the US and for trials on a global basis. However, there are some differences in procedures that must be followed when identifying sites outside of the US.
This webinar will cover a step-by-step procedure to identify high-enrolling sites for clinical trials. It will help the attendees to quickly identify low-enrolling sites to either remove them from the study or bring them up-to-speed. It will also explain the role of various departments in clinical trial site selection.
Areas Covered in the Webinar:
- A step-by-step procedure to identify high-enrolling sites for clinical trials.
- How to identify which countries and sites are the most suitable for conducting trials outside of the US.
- Determining cost to benefit of enrolling within various countries and between investigators.
- Determining the impact to the cost of development of the investigational product to the company using various enrollment scenarios.
- How to quickly identify low-enrolling sites to either remove them from the study or bring them up-to-speed.
- How to quickly identify high-quality and low-quality data sites and how to address issues in both of those scenarios.
- Role of various departments in clinical trial site selection.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Clinical Operations within the pharmaceutical, medical device or diagnostics clinical
- Business Development
- Regulatory Affairs
- All personnel within the company with an interest of conducting clinical trials more efficiently at overall lower costs with higher quality data
Adam Ruskin, PhD, DVM, MPH is the founder of LabCRO, Inc., one of California's largest Clinical Research Organizations. Dr. Ruskin was a researcher at the Centers for Disease Control (CDC), an FDA Advisor, and two-time TEDMED award nominee for innovation. He is the creator of LabTracker, the industry's first system for tracking clinical trial samples from the time of patient sampling until result posting. He has lead all clinical, data management and biostatistics activities at 4 successful start-up pharmaceutical, biotech, and medical device and diagnostics companies, and now leads successful clinical and data management teams for his clients through LabCRO. As a leading industry speaker for over 20 years, he knows the details of what it takes to get investigational products approved, especially under required budgets and timelines of most companies.
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