Who's Keeping Score? A Quantitative Approach to Trial Feasibility
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With most trials failing to meet enrollment timelines, current approaches for feasibility fall short of identifying and minimizing risk. Sponsors must arm themselves with the right tools to own this analysis throughout the trial lifecycle. We will discuss a quantitative approach that operationalizes feasibility score tracking. Luke Stewart used this presentation at Clinical Trial Innovation Summit in Boston on April 25, 2017.
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Who's Keeping Score? A Quantitative Approach to Trial Feasibility
- 1. 1Copyright © 2017, Saama Technologies Who’s Keeping Score? A Quantitative Approach to Trial Feasibility Luke Stewart Director, Product Management April 25, 2017
- 2. 2Copyright © 2017, Saama Technologies Trial Feasibility and Site Selection: A Losing Battle…?
- 3. 3Copyright © 2017, Saama Technologies Who’s Keeping Score?
- 4. 4Copyright © 2017, Saama Technologies Close Loop on Actual Performance vs Projected Scoring Attributes of Approach • Sponsor-driven • Systematic scoring • Learning over time Early Protocol Feasibility Site Feasibility Study Startup Study Execution 0 months-18 months -6 months 12+ months Scoring i.e., Protocol Amendmentsi.e., Site Surveys i.e., Site Screening Rate
- 5. 5Copyright © 2017, Saama Technologies Predictive Example PREDICTING PATIENT ENROLLMENT USING MACHINE LEARNING AND ARTIFICIAL INTELIGENCE: • Previous participation in clinical trials • Disease / Therapeutic area • Proximity to site • Study complexity • Demographic information • Socio-economic status PREDICTING SITE PERFORMANCE USING MACHINE LEARNING AND ARTIFICIAL INTELIGENCE: • Previous terminated studies at the site • Screen failure rate • Study complexity • Number of patients matching inclusion/exclusion criteria within close proximity (25 miles) of site • Socioeconomic status of eligible patients in close proximity of site • Disease / TA • Staffing and facility information
- 6. 6Copyright © 2017, Saama Technologies Call to Action Visit us at Booth 16 – Share your thoughts and stories – See demo Start Keeping Score
Editor's Notes
- So many stats… Preaching to the choir; we all know this Committed to improve patient experience: at least present opportunity to join trial that may help them soon; get therapy to market sooner to address indication Cost factor Patient centricity [graph with historical nature of problem]
- When feel losing, don’t keep score. Important to keep score like a scrimmage/pre-season so can assess and improve. Ex. Learning golf Who’s Keeping Score
- Feedback Loop – Assess Actual vs Projected Trial/Site Performance Inclusion/Exclusion Criteria evaluation As get more real-time info then can have higher confidence of the enrollment performance of your study/site; goal is to know this earlier so can avoid site abandonment and instead focus resources on sites with highest potential Benefits of this approach Systematic (limits bias of PI and CRO) Institutionalizes lessons learned about studies/protocols