Focused KPI Program Can Bolster Clinical Trial Quality Risk Management

Key Performance Indicators

Crafting an effective key performance indicator (KPI) regime from scratch is no easy task. If your parameters are too expansive, the data can become overwhelming. If too narrowly defined, the program’s full positive impact on your clinical quality risk management system can be blunted.

“When we first started, everybody wanted everything to be measured,” says Linda Peterson, associate director for Oncology Clinical Operations at Inovio. For a time, she and her team struggled to separate the wants from the needs.

The solution? Begin at the end of the decision-tree and work your way back, Peterson says. Determine what you need to figure out, then select the pertinent KPIs.

It’s not simple, of course. However, Peterson says one effective way to focus on the right data is to think in terms of attaining buy-in from senior management: “What kind of things will the executive want to know? What things do we need to measure to show whether we are successful or not?”

For example, as she and team built their program from the ground up, it became apparent that executives wanted more data about design issues around protocols (e.g., how many protocol amendments were caused by a design deficiency?).

Risk Management: The Crash Course

Prepared for risk management requirements in ICH GCP E6 (R2)? Join us at ACRP 2019 in Nashville this April and learn the key components of a risk management program and how to successfully conduct a risk assessment at the system and protocol level. Dr. Susan Lester of Barnett International will provide a high-level overview of quality risk management and leave you with practical takeaways and sample tools to use at your organization.

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ACRP 2019

It’s up to leadership to drive a culture that’s proactive about risk management rather than being reactive, Peterson says. Reward proactive behavior, but “do not reward reactive issue resolutions if the issue arose due to poor reactive risk prevention,” she adds.

Leadership must be “visibly and actively” engaged, too, Peterson says.

There are a number of advantages to adopting an effective KPI program. Peterson expects hers to help with vendor oversight, for starters. “My biggest hope is to have better measures so that we could articulate better to vendors about what they were doing well and what they were maybe not doing so well,” she explains. “We could be a better team.”

Finally, Peterson stresses that even the best KPI program is never finished. It’s critical to “keep challenging your KPIs,” she says.

Author: Michael Causey