In this special guest feature, Rani Hublou, Chief Product Officer at Comprehend, provides her views on why pharmaceutical data is such a sticking point for the R&D process. Closely aligned with customers and the sales organization, Rani focuses her team on enabling prospects and customers on Comprehend clinical operations solutions. She manages go to market strategy, lead generation, sales enablement, product marketing and branding. Her enterprise marketing experience is derived from her years with — B2B Software Companies: BEA Systems, SAP, VMware, PSS Systems/IBM, OneLogin, BroadVision, Icarian; McKinsey & Co and Accenture: innovated with the G500; Non-Profits: improved educational outcomes for underprivileged children in Santa Clara County; worked full-time at Rebuild LA to create jobs in South Central LA. Rani holds a Bachelor and Masters in Engineering Stanford University.
Clinical trials for new pharmaceuticals are typically long, complex and arduous processes. As a result, new drugs can take a decade or more to make it from the bench to the bedside and begin to actually help patients. Of course, patient safety is one reason, along with a lengthy FDA review process and backlogs. But, one hurdle in bringing new drugs to market faster is something arguably more frustrating: making clinical decisions under operational uncertainty.
- Are the studies doing what they planned to do?
- Is the CRO adhering to the quality plan?
- Is study performance meeting or exceeding our expectations?
- Where is the study or site meeting expectations?
- Where is it underperforming?
In fact, a recent survey of clinical operations leaders revealed that a startling two-thirds (67 percent) still rely on spreadsheets as their primary decision tool for managing clinical trials. That is a contributing factor for why fewer than 10 percent of trials are completed on time, delaying results, market delivery and ultimately, favorable patient outcomes.
This reliance on a spreadsheet decision support “system” means each study team is pulling data from diverse source systems in order to aggregate the data into a master study spreadsheet. Not only is this relatively manual process time consuming and difficult, especially when data from disparate systems complicates the harmonization, but it also introduces the risk of errors. By the time issues are investigated and escalated to team leaders, conditions have changed, resulting in painfully uncertain decision-making.
- If enrollment continues at current rate, how will that affect milestone achievement?
- Do we need to add sites to boost enrollment?
- If so, where do we add sites?
- How is enrollment relative to other studies in the program?
- Is one study less productive or more difficult?
- Are screen failures contributing to enrollment shortfalls?
- What is the risk that withdrawals will impact enrollment levels?
Fortunately, leading life sciences companies are utilizing a new breed of cloud-based clinical intelligence solutions that eliminate decision uncertainty. Clinical operations teams now have access to more powerful, best practice application software to actively conduct a clinical trial —from patient enrollment and compliance to data quality and site productivity—across disparate systems and studies. Continuous quality solutions provide data aggregation, monitors and forecasted analytics, and workflow for the portfolio’s key performance indicators (KPIs). Always on, continuous quality solutions are designed to handle the real-time data demands of executives and their clinical operations teams, to simultaneously reduce patient and regulatory risk, reduce excess cost, provide management insight into workflows, and accelerate trial productivity.
- Which studies, regions sites should we focus on to improve protocol compliance?
- Is the protocol deviation risk systemic, regional or site-specific?
- Is a specific visit the source of protocol deviations?
- What actions been taken and are in progress to reduce protocol deviations?
Aside from eliminating the time-consuming and risk-inherent process of manual spreadsheet use, these new solutions provide unprecedented operations visibility across the portfolio in a single dashboard for VP-level executives through to CRAs. With a cross-study, cross-system dashboard that provides simple, at-a-glance indicators for metrics thresholds (red, yellow and green), study managers and executives have a much clearer picture of current milestones and projected progress. Now, they can proactively address potential enrollment and compliance issues, drill down to see the complicit factors and correct potential problems before they impact progress.
- How should we optimally deploy our monitoring resources?
- Which issues should we escalate with the CRO?
With built-in real-time monitoring capabilities, continuous quality solutions alert team members at all levels at the first sign of deviations, outliers or delays. This provides insight into issues as they unfold across dozens of active studies in a portfolio, providing ample time for corrective action. Because trial data and dashboards are all managed, stored and accessible in the cloud, this enables team managers and executives to understand which trials, sites and indicators are at risk, and review plans with actual and forecast data, to determine appropriate steps. Leaders can assign tasks and monitor their implementation within the dashboard, while teams at each site can be more proactive in taking steps to put studies back on track.
- What KPIs do the executives need on their continuously updated dashboards?
- What thresholds, alerts and notifications do we set for our priority KPIs?
This new way of operating and ensuring continuous quality in the data is creating efficiencies that will forever change the way clinical trials are managed. With real-time situational awareness, the ability to take immediate corrective actions and live collaboration across multiple sites, clinical operations teams now have a strategic solution to help them make smarter, faster decisions to ensure compliance and productivity across their entire portfolio of studies.
This new approach to data management, analytics, collaboration and quality assurance promises to deliver both operational and financial advantages for clinical research organizations, potentially eliminating months of delays and hundreds of thousands of dollars per study. And, equally, these advances translate directly into faster time-to-market for new pharmaceuticals and help to reduce the cost of critical drugs for patients, which can dramatically accelerate and improve access to the latest life-saving treatments.
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