The Challenge with the Current Approach
Metrics, analytics, artificial intelligence, big data…these are the hot topics of clinical research today, all in hopes of finding the magic bullet to plan trials, predict site performance and select the best sites, and execute trials successfully. There are so many initiatives along these lines, and while there are certainly plenty of exciting endeavors and progress being made, they tend to be very targeted and not easily applied to other organizations. Most importantly, they tend to use limited data that may actually skew the perspective gained, like the man looking for his keys under the light because that’s the only thing he can see, not actually where he likely lost them.
Sponsors have been talking about how to use metrics for a very long time, through initiatives including the Metrics Champion Consortium, the SCRS site study dashboard initiative and others. The challenge in implementing such initiatives is not in the value or identifying which metrics would be useful, but rather in the lack of standardized data. The variety of trials and therapeutic areas, as well as the mix of outsourced trials versus sponsor-led trials make it difficult for sponsors to collect standard data and understand holistic site performance. Even for those sponsors that have their data standardized, they are unable to understand how sites might perform with other sponsors or how the site may define major milestones differently than the sponsor. Based on your own set of data, it can be easy to make subjective conclusions about the state of a site, but how do you know if your assessment is correct or if there’s a targeted way you can help?
Understanding the historical performance of a site for study startup timelines and enrollment targets met for particular types of trials, for example, is critical for sponsors and CROs to more accurately and effectively plan for upcoming trials. Leveraging only data sources that the sponsor or CRO has limits their ability to plan and continue to identify new potential sites.
A Better Approach
There has got to be a better way! To take on these challenges, Forte is launching a new initiative that approaches this problem from a new perspective to enable better partnerships between sites and sponsors. This can be done by inverting the traditional focus which is typically single sponsor-centric, and instead taking a cross-sponsor, site-centric approach. Not only are sites critical to running clinical trials, but large research centers also have a treasure trove of data due to standardized processes and technology they employ across their organizations.
Leveraging these large data sets, Forte launched the site-focused Benchmarks initiative in 2013 which was able to aggregate this standardized data and provide comparative analytics for sites to be able to compare themselves to anonymous aggregate performance data of their peers.
The Sponsor Scorecard Initiative
Taking a similar approach, the Sponsor Scorecard initiative leverages research centers’ vast experience with all sponsors. What this means for sponsors is that they are no longer confined to their own experiences, but can leverage the sites’ experience across all of the sponsors.
By taking this approach, sites and sponsors can see the same set of historical data of their joint performance compared to the research center’s performance with all other sponsors. This enables them to have data-driven, transparent conversations that lead to true progress. The Sponsor Scorecard pilot is currently in progress and includes select research centers and sponsors who have this mutual goal in mind.
The Sponsor Scorecard will include metrics such as overall study startup timelines, as well as sub-processes like Clinical Trial Agreement, IRB, Contract and Budget turnaround times, as well as Open to Enrollment to First Patient In. It also will include enrollment performance compared to the target, in addition to site payment turnaround time. These metrics are focused on a research center/sponsor joint performance compared to that research center’s experience with other sponsors. Several filter options enable further analysis, for example, to understand specific therapeutic areas performance or impact of a CRO on performance.
From the sponsor perspective, having the same definitions of metrics, such as what is considered the trigger point for certain activities and study start-up, will be extremely valuable to drive better process improvement initiatives. Being able to understand a site’s processes more clearly and focus on specific areas of improvement for the joint site/sponsor relationship will help target study teams’ activities in the most impactful way.
Teri Grieb, Senior Director of Research and Chief of Staff at the University of Michigan Medical School, said of the Sponsor Scorecard, “This will enable us to have fruitful conversations about how we both contributed to our performance, and as partners how we can both contribute to what we want, which is quicker activation and stronger joint performance. By leveraging the data we have enterprise-wide in our clinical trial management system to drive our conversations, it will foster transparency, open dialogue and mutual process improvement together.”
Benefits to the Site-Centric Approach
In summary, by enabling sponsors to see research center data, research centers can have more productive, transparent conversations which will help them focus discussions on specific areas of performance, and it will enable research centers to proactively work with sponsors to address any challenges. Sponsors will gain deeper insights into the collective site/sponsor performance by having access to the site’s performance with other sponsors as well. The ability for both parties to speak the same language enables sponsors and sites to work effectively together to improve joint performance.
Another related initiative that takes a site-centric approach is the Trial Data Exchange, which is focused on making every trial a success by interconnecting stakeholders. Learn more through prior articles here.
Forte Founder and CEO Shree Kalluri said of the project, “This is the culmination of 19 years in the making where we have collaborated with research centers through standards-based technology. We are extremely excited to be turning this page and entering the new frontier of clinical research where stakeholders are truly collaborating and finding ways to expedite drug development together.”
Learn More at Onsemble
I’m very excited about Forte’s vision to better connect Site and Sponsor teams. If you’d like to learn more, consider joining us at the Spring Onsemble Conference, where the Forte Leadership and Product teams will provide an update on our advancements in helping trial teams transform the clinical research industry.