Saama continues our new blog series, “Saama to the Rescue,” in which we profile common, real-life challenges encountered by various levels of clinical trial leadership every day, and how Saama solutions can pave the way for more efficient and effective clinical operations.
We recognize that, in any clinical study, trial leadership at every level have an abundance of details to manage, people to supervise, deadlines to meet, and budgets administer, among other things. What trial leadership does not have is an abundance of time to solve the inevitable challenges that arise in relation to these various moving parts. Saama can help.
Our fourth installment focuses on a fictional Central Monitor in a trial conduct scenario.
Situation: “Welcome to the company, Sue.” As the new Central Monitor at XYZ Pharma, I hear that a lot these days, which is great. However, I want to quickly turn those greetings into acknowledgements of my contributions to the company. Though gaining traction in the industry, the Central Monitor position is still a comparatively new one, and I left my previous company because I was frustrated at its failure to support the role and provide critical resources. XYZ Pharma is very forward-thinking, so I already feel more empowered and well-positioned to earn the trust and respect of my colleagues. “Great job, Sue” would be music to my ears.
Challenge: One of the critical factors in my decision to join XYZ Pharma were the state-of-the-art technology and solutions the company’s Central Monitors can leverage to oversee and manage trial portfolios. This morning when I log into Saama’s Life Science Analytics Cloud (LSAC) to check the status of my compound’s trials, I notice that, across the portfolio, data entry rates look good (indicated by green), but the percent of source data verification (SDV), discontinuations and unresolved data clarification forms (DCFs) are in yellow. They need my attention. However, of most concern are the high number of serious adverse events (SAEs), adverse events (AEs) and protocol deviations, which have been red-flagged. Clearly we have some major issues that need to be addressed ASAP.
Solution: As I mentioned, the ability to leverage a platform like LSAC is one of the benefits that drew me to XYZ Pharma, so I take full advantage of its capabilities to get to the bottom of these problems and troubleshoot. When I click on the red-flagged areas, I notice that Spain and Belgium are reporting higher incidences of SAEs, AEs and protocol deviations than their peers on the same three studies. By clicking through on Spain, I see that four sites in particular, run by Drs. A, B, C and D, are causing these discrepant numbers. Each have higher numbers of unresolved DCFs and patient discontinuations. Even when we normalize for the number of patients at these sites, the numbers are still out of line. This could possibly be a training or site resource issue across these four sites, or there could be something else going on. I get in touch with my clinical research associate (CRA) in Spain to discuss the situation, and agree that immediate site visits are required to identify the issue. My CRA drops everything, heads to each site, then calls me back. It turns out that each site recently lost some personnel and hired new team members. Re-training is required to ensure protocol compliance and related safety, and we implement that at once.
Summary: The ability to arm myself with such a powerful, AI-enabled tool as LSAC was one of the factors that drew me to XYZ Pharma, and my instincts were on-target. LSAC not only flagged serious issues in real-time, it’s statistical analysis of the at-risk sites and trial elements triggered critical site visits and the subsequent response to rectify potentially disastrous situations. As the life sciences industry continues to trend toward centralized monitoring, solutions like LSAC will support the function, enhance patient safety, improve data integrity, and ensure clinical development success. And it also got me my first “Great job, Sue.”
To learn more or request a demo of Saama’s Life Science Analytics Cloud, click here. “Saama to the Rescue” will continue next week with a look at how LSAC supports a Trial Manager in a planning scenario.