I’m sure everyone has heard the saying “team work makes the dream work.” Is it a little cheesy? Sure. Over-used? Probably. Does it apply to the performance of a clinical trial? You bet it does – let me explain.
When you think of your clinical trial ‘team”, you may initially focus on key individuals within your organization. These are the folks you collaborate with frequently, see in-person around the office, and maybe even sit next to. This is your immediate team, so to speak. Let’s also consider the expanded team. This includes folks from other organizations, who may represent another research Site, a CRO, or a Sponsor. Although titles, roles, and locations vary, at the end of the day, the full expanded team is all working toward successful completion of the study.
At Forte, we strongly believe that technology can help your expanded trial team. We’re actively working on several initiatives that will create breakthrough efficiencies, not only within individual Sites, but also between Sites and Sponsors.
Trial Data Exchange
Our solution to better connect Sites and Sponsors is the Trial Data Exchange (formerly known as DIRECT). The idea is to standardize and automate the data exchange between stakeholders, rather than relying on ad hoc communication and manual report compilation. Where the Trial Data Exchange will be able to exchange multiple categories of data, today I’m going to focus on operational data created within the trial lifecycle. Today’s current method of sharing operational information such as the schedule of events, study start-up status, or subject visit completion, is shared inefficiently, often manually.
Current State Challenges
Let’s take the schedule of events, also known as the protocol calendar, within the protocol document for example. The success of the clinical trial hinges on the sites’ understanding of the protocol calendar and ability to adhere to that plan throughout the study. The current way this information is shared is a Sponsor will email a text-heavy PDF of the protocol document and calendar to each Site when it’s ready. This introduces risk that the details of the study will be interpreted and entered inconsistently into Site CTMS applications, which are used to direct their research activities. This is further complicated by the amendment process. As amendments are made, the changes to the protocol need to again be distributed to the Sites and entered. Without a central source of truth, the protocol’s definition, eligibility criteria, or schedule of events across sites could easily get out of sync and compromise the quality of the clinical trial.
Enrollment progress and visit completion data are also shared manually from the Site back to the Sponsor today. This adds administrative burden for both teams. Sponsors need to request progress updates on a regular basis. Site teams then need to export, compile, and share out reports. Finally, Sponsor teams need to combine the reports from each Site in order to create a comprehensive view of how the study is progressing. Since this process takes time, the data shared quickly becomes outdated, which impacts the quality of the decisions that can be made.
Efficiency Through Automation
Thankfully, there’s a better way. The goal of the Trial Data Exchange is to build a connected ecosystem and promote real-time, data-driven discussions between Sites and Sponsors. Forte is currently working on several initiatives to achieve this goal. One initiative that I’d like to share is called the Enrollment and Visit Visibility Pilot. This new application will show Sponsor teams the enrollment and visit completion metrics they use to analyze the overall performance of a study by leveraging on Site systems. This approach directly utilizes data that Sites are already tracking on a day to day basis and provides information much faster than a Sponsor typically is able to see. This enables Sponsors to proactively identify issues at one Site that may impact other Sites, before they encounter the same problem. Not only will they be able to see trends across Sites, Sponsor teams will also be able to dig into the metrics of a single Site to better understand what’s going on.
As mentioned, operational data is a broad category of trial data. The team leading this project is starting with enrollment and visit data for several reasons. First, meeting enrollment goals is a real challenge that we know Sites and Sponsors are facing. In fact, according to a recent abstract published by the Journal of Clinical Oncology, about 38 % of the CTEP/NCI supporting oncology trials close due to inadequate enrollment, though this problem is not limited to oncology. Secondly, the Forte customer community is already using OnCore to manage enrollment and visit workflows. We have the opportunity to help Sites and Sponsors better collaborate, without changing the processes Sites use today.
The Enrollment and Visit Visibility Pilot is open to small group of Sites and Sponsors so the Forte team can gather feedback and iterate quickly. Sites that chose to actively participate in this pilot will be able to share relevant enrollment and visit metrics seamlessly with trial Sponsors through the Trial Data Exchange.
Learn More at Onsemble
I’m very excited about Forte’s vision to better connect Site and Sponsor teams as well as the progress that the Enrollment and Visit Visibility Team is making. If you’d like to learn more, consider joining me 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.