CSI: Clinical Site Intelligence

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CSI: Clinical Site Intelligence

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Clinical Site intelligence provides sponsors and CROs with a method to analyze data, measure performance, and more confidently predict results on investigative sites for clinical studies. ...

Clinical Site intelligence provides sponsors and CROs with a method to analyze data, measure performance, and more confidently predict results on investigative sites for clinical studies.

It draws upon the perspectives of Christy Gilchrist and Todd Tullis, as well as questions common asked by sponsors and CROs.

Addressing topics like...
- the predictive approach to site selection
- measuring and sharing metrics during startup
- evaluating performance vs plan
...and many more!

The CSI document is presented simply and clearly, and is elaborated more fully in each successive slide, providing a rich set of questions for people who are interested in asking the right questions when assessing sites.

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  • 1. Christy Gilchrist Todd TullisBriefing on Director of Research Sr. Director, Product ManagementSite selection & startup Wellspan Health goBalto, Inc.
  • 2. What is site intelligence?• Our capability to analyze data, measure performance, and more confidently predict results• For CROs, sponsors, and sites
  • 3. If you could wave yourCSI magic wand…What would be included?What would that mean to you?
  • 4. Haven’t we asked thesefeasibility questions before? Which sites do we think will enroll at a sufficient rate? Can we trust these new sites? Is our investigator database current? This change won’t bean issue for sites, right? What are the ‘initiation wrinkles’ for this site again?
  • 5. Haven’t we answered these feasibility questions before? (like, last week?)Do we have the right Will we get another chancepatients for this trial? if we say “no”? Is this study good Doesn’t the sponsor for our business? have our CVs on file? What’s my plan for What do I need to do IRB approval? to get initiated?Have we been selected? When will we be ready to enroll?
  • 6. Site example:strategic research program planning• Find your niche• Tell the world• Contacting you must be easy
  • 7. Sponsor/CRO example:a predictive approach to site selection• Objective and subjective measures• Everything is relative• Finding historical data can be tough• No substitute for building site rapport
  • 8. Site example:EHR analysis for enrollment expectations• Screening/flagging potential patients• Epidemiology models for patients, advertising• Statistical modeling for success• Contract specifically for patient feasibility
  • 9. Sponsor/CRO example:measure & share metrics during startup• Site and sponsor “responsiveness” to startup tasks• Real-time intelligence facilitates faster resolution• Transparency to metrics can drive performance
  • 10. Site example:evaluating our performance vs. plan• Enrollment goals met – target numbers and date?• Compliance goals met?• Business goals met – plan budget vs. actual cost?• How can we do better next time?
  • 11. Sponsor/CRO example:post-study utility of CSI data• An opportunity to build better relationships • “They never offered to share the data they were keeping on me”• Allow for rationalization of outlier metrics• Should performance data be posted to registries? • Rafael Dal-re et. al, 27 Dec 2011
  • 12. Takeaways for sponsors/CROs: for sites:• Measure what you • You are selling usable think is important data, and plenty of it!• Data can motivate • Preparation pays off• Sites care about • Leverage the data that your evaluations you collect
  • 13. Thank you! Christy Gilchrist Todd Tulliscgilchrist@wellspan.org ttullis@gobalto.com