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Using Metrics for Quality Improvement Enhancing Clinical Investigation by Improved Management

Using Metrics for Quality Improvement Enhancing Clinical Investigation by Improved Management. Tesheia H. Johnson, MBA June 24, 2008. Yale University School of Medicine. Major Programmatic Goals of CTSA Program.

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Using Metrics for Quality Improvement Enhancing Clinical Investigation by Improved Management

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  1. Using Metrics for Quality ImprovementEnhancing Clinical Investigation by Improved Management Tesheia H. Johnson, MBA June 24, 2008 Yale University School of Medicine

  2. Major Programmatic Goals of CTSA Program • Regulatory Support for research teams to protect human subjects and facilitate regulatory compliance. • To create a true “One Stop Shopping” for all resources needed for the design, implementation & oversight of clinical and translational research studies. Workshop Goal: Enhancing Clinical Investigation by Improved Management • In order to achieve these goals our collective centers must focus on broad quality improvement based on defined success measures

  3. US Reduction in the Market Share: Sources of 1572 filings Source: Thomson CenterWatch Analysis 2006; FDA, 2006

  4. US Reduction in the Market Share: First Time Investigators Source: Thomson CenterWatch Analysis; FDA, 2008

  5. Shifting Share of Clinical ProjectsShare of Industry-Sponsored Projects % % % % % % % % % % % % % % % % % Source: Thomson CenterWatch Analysis 2007

  6. Factors Most Often Causing Study DelaysUnited States Source: Thomson CenterWatch 2007 Survey of 522 Investigative Sites in the U.S.

  7. The Local Setting The CTSA Opportunity • To consolidate the review process • Work collaboratively with University Compliance, IRB, and Contracting Office Challenges/ Roadblocks • As competition for clinical research support has intensified, sponsors are looking much more closely at time to initiation. In order to be considered a top-tier research site, Yale’s study initiation process will need major improvements to its implementation timeline. • Major factors in study delay are within our control • Many delays are as a result of an internal process • Changing the culture has not been / will not be easy • Metric Needed for Quality Improvement: • Contract approval timeline (from receipt by PI from sponsor to final sign off) • IRB approval timeline (from submission by PI to final IRB approval) • We will be tracking all events and time associated with each.

  8. The Local Setting The CTSA Opportunity • To provide PIs with appropriate support at all levels of the study process to relieve process burden Challenges/ Roadblocks • Developing a structure that will maximize subject safety and allow for data collection for tracking purposes, without developing institutional processes which will be burdensome to investigators • Metric Needed for Quality Improvement: • How does our internal process influence study start-up and does the process add value? • We will be tracking all events related to internal processes, time associated with each, and PI perceptions.

  9. National CTSA Role: Using Metrics We have all been asked to collect data on our institutional study implementation process and timelines. How can this be used to improve overall quality? • Demonstration of capabilities to the outside world • Promotion of best practice sharing • Allow individual institutions to compare data and influence leadership regarding enterprise-wide change • Without a starting point, how can we show the added value the CTSA will bring to clinical and translational research

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