Clinical trials can’t focus on everything when it comes to process improvement, so sponsors and sites need to focus on critical success factors, such as data reliability and protecting subjects.
Sponsors need to follow data end-to-end, from subject to final database, and look for weak spots, said Keith Dorricott of Dorricott Metrics and Process Improvement at a WCG-sponsored webinar. Think about, for example, what processes data go through, whether vendors or subcontractors are involved, and whether there is any data transfer.
Once critical success factors are defined, said Linda Sullivan, president of Metrics Champion Consortium (MCC), you need to identify key performance questions for each factor to tell you whether you are on track to achieve those success factors.
It’s often a challenge to decide what level of metrics you need to analyze, Dorricott said. He noted four basic levels:
Portfolio – Measures across multiple studies, which are useful for vendor oversight;
Study – Measures across a single study, which also are useful for drill-down of portfolio-level metrics;
Country – Measures across a country, which are useful for oversight of country-specific challenges and drill-down of study-level results; and
Investigative Site – Measures site performance against a target or compares against other sites in the same country or study.
Sullivan likened metrics-based risk management to a three-legged stool: trial success is the seat propped up by the legs of time, cost and quality. All three legs matter, she says. Too often, metrics focus on just one and neglect the others, unbalancing the stool.
“What you measure sends a signal about what you think is important, and it does, in fact, influence behavior,” Sullivan said. “Using a balanced set of metrics provides those incentives for people to behave the way you want them to.”
For more information on metrics and risk management, register for MCC’s Clinical Trial Risk and Performance Management Summit scheduled for September 4-5 in Philadelphia.
