For several years the Clinical Organization has tried to build operational delivery visualization tools for trial planning and monitoring using live data from clinical trial management systems. The attempt failed many times due to a lack of overall process and systems thinking, limited technical capabilities in integrating clinical trial information from various data sources, limited partnership between Clinical and IS, and time constraints from subject matter experts in shaping the right user requirements. In the absence of robust eClinical integration and visualization tools, the clinical organization continued to manage enrollment and trial performance in spreadsheets and other diverse primitive tools. The various stop-gap approaches also resulted in poor data quality in the primary trial data sources and the use of key systems deteriorated over time.
Thinking it Through
Several workshops were developed to break out the various tasks and to focus our delivery (business focus):
- Critical business need,
- Eclinical eco-system environment
- Integration and BI tools to use, and,
- A goal of Simple / intuitive / easy approach to use meaningful information.
- To meet these needs there were two other key areas of focus (IT focused):
- Assess the eco-system environment used by Clinical systems (CTMS, EDC, etc.), and,
- Assess the metadata standard across the systems and formulate an information management plan.
These latter two were an obvious extension as this focused on the availability of the source data. Making sure that the integrations were the key part of the overall development of the operational data visualizations resulted in the data being readily available for our initial implementation as well as for future enhancements. Without proper eclinical integration strategy and implementation, dashboard build effort would not achieve any success to gain business efficiency and benefits.
The Business Need
The primary business need was the standard reporting of a study to senior management. The secondary need was to make a more efficient use of the Project Manager’s time: measured as how much time is returned to the Project Manager if the senior management team requests are now fulfilled by the tool? The other supplementary efficiency for the Project Manager was found in the assessment of how much replication of data can be removed, as a task, from the Project Manager. This was measured as how much time is returned to the Project Manager if we integrated the data to allow for only single-point-single-system entry?
The Integration & BI Tools
MedImmune conducted an enterprise-wide review of automated tools available and which would be supported by IT. The assessment and evaluation of the tools would look at the pros and cons of each tool and focus on the best use. Using the suggested tool as outlined from this review would result in easy adoption of the tool. The integration tool was Oracle SOA platform and the visualization tool adopted was Qlikview for operational data visualizations in a dashboard.
Simple / Intuitive / Easy to Use
The business users felt that the dashboard tool should be intuitive without much training. Make the tool easy and simple by allowing them to navigate the tool at their leisure. This would prove a very beneficial decision as the tool became more widely used than anticipated. With the added number of users, the tool gained momentum.
The release of the first Dashboard with aligned eclinical integrations came six months after the requirements were first gathered. To complete the assessment, once the dashboard was released a survey was distributed to see the response from the end users. The response actually provided great feedback as well as an 87 percent rating to continue building on the initial dashboard.
- Subsequent Releases: Further enhancements were added to the next iteration of the Dashboard:
- Study Budget / Spend
- Efficient use of Clinical systems (phase 2)
With the requirement of adding budget/spend visualizations the integration to the financial system was done. And, with the additional efficiency gains several other integrations needed to be completed. An example was the integration of IVRS data to our EDC and CTMS systems. In this instance, the efficiency gain was to the clinical site where the site would only be required to initiate the IVRS entry. The data would replicate to EDC and to CTMS removing the duplicate entry burden placed on the site, specifically between the creation of a subject in IVRS and placing the same information in to EDC.
Automated Clinical Delivery Dashboard
The Clinical Organization is at a pivotal juncture to deliver a huge portfolio of studies at unprecedented timelines. Having a consistent and easy to use tool to plan, manage and monitor trial performance by all levels of the organization is critical to enable delivery of our portfolio. With strong cross-functional collaboration between Clinical and technology team, the team delivered the first Automated Clinical Delivery Dashboard that displays live data directly from the main clinical trial management systems in record time. The team completed the tool development from concept to launch in six months (compared to > six years of several repeated and failed attempts). Since the launch of the new automated dashboard, we have seen ~30 percent – 50 percent improvement in data quality in our primary data sources and are forecasting ~3,000 hours/year of time savings by eliminating other redundant reporting. Today, all MedI active clinical trials across 37 countries, >700 sites with > 3,000 active subjects are easily accessible across the enterprise.
Best-in-class Digital Innovation
This eClinical integration and automated visualization platform is clearly industry best-in-class. It’s very easy to use without any training and has customizable views that are fit-for-purpose at all levels of the organization. Using an adaptive agile approach, the tool was fashioned from the generation of user stories based on “what are the critical business questions?” The answers were the basis of a storyboard that took the shape of a wireframe that was a simple slide visualization of the data. Agreement of the team on the slide visualization was then programmed to build the back-end connection to the data sources.
The eClinical Integration & Dashboard has provided the real time progress and metrics transparency of critical clinical studies to the organization through best-in-class integration technology. The project has been recognized as a Process Excellence example at major industry conferences. It has also built a solid foundation for the future One Clinical Delivery Dashboard for all the clinical trials across three R&D Science Units within the whole AZ Company.
*Ron Bourque is the Associate Director of Clinical R&D IS Business Management & Analytics at MedImmune, LLC