Case Study: How a Continuous Risk Reduction System Drove RBM Success
October 6th, 2015
By Rick Morrison, CEO and Founder Comprehend Systems and Ken Wu, Former Head of Clinical Operations at Scios, a Johnson and Johnson company
The VP of Clinical Operations at a global medical device company was increasingly anxious about the emerging negative trends on three studies. Three out of seven studies had turned from green to red on his Continuous Risk Management dashboard. The studies were critical to the company’s future, and competition in this cardiovascular indication was fierce. A delayed launch in the multi-billion dollar opportunity would translate to a loss in market share. No one needed to remind him that his job and the future of his department, was at risk if the company lost its leadership position.
In previous years, even the most experienced and skilled study teams, had trouble manually updating and tracking performance indicators on an ongoing basis. The teams were distracted collecting and tracking metrics and failed to recognize risks early enough. The VP of Clinical Operations described his portfolio with ‘risk uncertainty.’ He was unsure about what risks existed and where they were throughout the study portfolio.
Fortunately, his organization had recently piloted a Continuous Risk Management solution on a handful of studies. When 3 studies turned to red on his Continuous Risk dashboard, the VP of ClinOps was able to leverage the solution to quickly return the red studies to green.
Through a case study, this post illustrates how a leading ClinOps executive leveraged a Continuous Risk Management Solution. The team used the solution to drive their RBM program and return their “red” high risk studies to “green” in weeks not months.
Action 1: Identify the root cause of emerging study risks
When study #3 breached the risk score threshold with a score of 60, the VP of ClinOps received an urgent alert on his cell phone. By clicking on Study #3 on his dashboard, he was given specific details about the alert:
- Several sites in Study #3 had excessive levels of queries and was taking three times longer than other sites to close them
When reviewing the task assignments, the VP of ClinOps saw that the study leader requested additional monitoring support from the CRO to close queries and retrain the site to reduce the number of queries.
Action 2: Track assigned corrective actions to ensure quick achievement of desired results
Study #5 also triggered an alert on the Continuous Risk Management dashboard. The click through from the dashboard revealed that two sites had higher than expected missing endpoint data.
The VP of ClinOps was able to view the study leader’s instructions to the in-house CRA. The action was to assign the CRO site monitors to follow up on missing data points at these specific sites. The CRO monitor acknowledged the assignment and scheduled a site visit with the study coordinator.
Action 3: Proactively manage a forecasted risk
Study #6 was the most troubling among all three studies out of compliance. A click through from the study level dashboard to EDC revealed that:
- Three sites had more protocol deviations than planned
- Protocol deviations were higher at visits 5 and 6 when compared to other visits
- Several patients recently completed visit 4 and were scheduled for visit 5
The study leader immediately convened a meeting with the CRO and study team to discuss potential root causes for the high deviation rates at the three sites. There seemed to be a correlation with protocol deviations at visits 5 and 6. This suggested that a high protocol deviation rate may be related to protocol design.
By taking a proactive, continuous approach to risk management, the VP of ClinOps was able to:
- Forecast acceptable risk variances based on enrolled patients, by study and indication
- Alert a study team when studies breach a predetermined risk threshold
- Assign corrective actions and track them with a deadline for completion
- Validate that corrective actions were successful, showing studies returning to green
Within two weeks, the VP was relieved to see all studies were tracking well under the overall risk score. The program Continuous Risk Management dashboard confirmed previous RED studies were back in the green and continued to trend within the preset risk thresholds.