While the ICH E6 addendum, (R2), is already in force in Europe, the FDA has yet to publish the final guidance here in the U.S. Sponsors and CROs alike have been evaluating, discussing, and generally worrying about how to prepare for this guidance. The draft guidance sets out some key areas to focus on, but every pharmaceutical company must make considered decisions as to how to align its processes and automation.
A 2016 poll of clinical leaders from global pharmaceutical companies revealed that ICH E6(R2) compliance was a top priority for more than 70% of respondents, yet 90% said they were still using spreadsheets for oversight and collaboration—resulting in delays of more than 6 months in some cases, as well as significant cost overruns and failed inspections. Issues such as these were discussed in a recent Comprehend webinar, where a number of best practices were presented to help sponsors and CROs find their way through the ICH E6(R2) maze.
While every organization has its specific goals and hierarchy, the “12 Best Practice Steps to Operationalizing ICH E6(R2)” can help companies conducting clinical trials think through key areas where alignment with regulations can be a challenge. With regard to the addendum, areas such as risk management, sponsor-CRO collaboration and oversight, and the use of automation must all be addressed.
In a Metrics Champion Consortium (MCC) presentation at last year’s Clinical Metrics Performance Summit, founder Linda Sullivan pointed out that pharmaceuticals should not only consider oversight at the study level, but also at the operational and executive levels. Each of these concerns requires a hard look at the steps pharmaceuticals are taking to reach database lock, while considering the requirements of the new addendum.
Understanding the Guidance
In our ICH E6(R2) webinar, we spell out FDA guidance for the addendum and explain the technology and process alignments organizations should be considering. In one example, we show how collaboration among study strategists, vendor managers, and operational leaders can ensure adherence to quality agreements, oversight plans, and data transfer agreements. By operationalizing quality agreements, for instance, agreed-upon metrics can be automatically measured in real time, and freely shared by the sponsor and CRO. What’s more, appropriate team members can be automatically alerted when breaches occur, making issue identification and resolution much more efficient.
Linking Plans to Automated Insights
The webinar defined four areas where sponsors can apply automation to support ICH E6(R2), but the key to success is the ability to unify and update clinical data from disparate systems. 73% of respondents to a recent Comprehend poll agreed that the most difficult part of operationalizing to ICH E6(R2) comes from aggregating and harmonizing data that needs to be reviewed, evaluated, and reported on. When managing data from in-house sources and external partners, sponsors are overwhelmed by the effort required to make decisions based on rigorous analysis.
However, if the data can be integrated in a timely manner and updated in real-time through automation, the stress and frustration can be alleviated. The key to peak clinical trial performance depends on the ability to visualize the current status and progress of studies, sites, systems, and vendors in real time. With the right scorecards and dashboards, study teams can make better decisions early enough in the study phases to impact the success of every project.
Editor’s Note: Since this blog was first posted in 2017, we’ve made it even easier to manage oversight with the Comprehend Oversight Scorecard. This powerful new data visualization and analytics solution delivers a quick, comprehensive overview of risk, quality, and performance Indicators across a single study or an entire portfolio. With the Oversight Scorecard, users can monitor scores for sites, studies, countries, and vendors—based on pre-selected metrics—to make better, faster decisions.
We’re Here for You!
Let us help you overcome your clinical trial challenges.