DIRECT: The Vision for a Connected Clinical Research Industry

Shree Kalluri
Founder & CEO, Forte
October 4th, 2018

In my previous blog post, I discussed the clinical research industry’s consistent struggle to effectively communicate necessary information to enable efficient and successful clinical trials.

In the current research landscape, information exchange between industry stakeholders is still very manual and ineffective. Distrust and miscommunication have created barriers where effective communication is most valuable, such as during site selection, study feasibility and trial conduct. Sponsors/coordinating centers struggle to find sites that can successfully take on their studies, while clinical research sites lack the information they need to make accurate enrollment estimates. Sponsors lack real-time visibility into study status and trial conduct, while sites are required to manually enter data into multiple sponsor systems. These disconnects between the two stakeholders lead to severe consequences and profound inefficiencies in clinical trial conduct.

What if we could leverage the systems sites are already using to streamline the communication of critical trial information? What if we could give all stakeholders the information they need without increased administrative burden?

Creating a connected clinical trial ecosystem

At Forte, we’re actively working to develop a more streamlined approach to data exchange in the clinical research industry. At the 2018 Spring Onsemble Conference, I introduced DIRECT, an initiative focused on addressing the challenges of conducting multi-site trials by developing a connected clinical trial ecosystem.

The DIRECT concept is to create a two-sided network, where systems used to collect clinical data and optimize research performance are connected and channel information to each stakeholder for more efficient and higher quality clinical trials. In this ecosystem, sponsors are able to seamlessly send sites protocol documents, draft budgets and coverage analyses, while sites in return provide up-to-the-minute activation statuses, subject registrations and visit completions. Sites save time with eTMF documents that are automatically uploaded and CV’s updated based on their electronic regulatory (eReg) management systems. And finally, sites manage their electronic case report form (eCRF) data, populated from electronic health record (EHR) systems data and a site-centric eSource system, to provide data to sponsors quickly and accurately, eliminating the need for source data verification and truly enabling risk-based approaches.  

Integrated Solutions

Connecting the systems sites already use to collect, manage and report on clinical operational and trial data across their enterprise is a key part of the DIRECT initiative. Systems such as EHRs, clinical trial management systems (CTMS), eReg systems, and more act as the source of truth for clinical operational and trial data for research sites. Integrating these systems would eliminate duplicate data entry and significantly improve communication among stakeholders.

With DIRECT, our goal is to build an infrastructure that connects these integrated systems at the research site with the sponsors’ electronic data capture (EDC) systems to create a seamless flow of information. This would allow sites to use the same system for all clinical trials they participate on, regardless of the trial’s sponsor or coordinating center. It would allow sites to manage their entire research portfolio using their existing infrastructure. 

The DIRECT Consortium

Since I introduced DIRECT in March 2018, we brought together a group of leading research institutions, such as Yale University and Duke University, to create the DIRECT Consortium. The purpose of the consortium is to make seamless data exchange a reality and determine guidelines to enable faster digital exchange of clinical research data through connected technology. While DIRECT has the potential to benefit both industry and investigator-initiated trials (IITs), the Consortium’s initial focus is to test the infrastructure of interconnected systems for multi-site IITs.

After numerous collaboration calls, we brought members of the consortium together for an in-person meeting and panel discussion at the 2018 Fall Onsemble Conference. Representatives on the panel included Tesheia Johnson, Deputy Director and Chief Operating Officer of YCCI and the Associate Director for Clinical Research at the Yale School of Medicine, Denise Snyder, Associate Dean for Clinical Research at Duke University School of Medicine, Mathew Innes, Administrative Director of the Clinical Research University of Michigan Rogel Cancer Center, and Nick Fisher, Executive Director of Research & Business Administration at the Siteman Cancer Center.

Visions for a connected industry

During the panel, consortium members explored their visions for a connected clinical research industry, including the potential benefits, as well as hurdles that will need to be overcome.

Johnson expressed her enthusiasm about the increased transparency connected systems could bring to all stakeholders. “We’re really at the beginning of the kind of innovation that can happen when we all work together… If we could all see each other’s dashboards, recruitment data, activation timelines, and where we are in the study at any given time, it could really change where we all go” she said.

In addition, Fisher noted the extraordinary potential benefits of connecting a site’s eSource to sponsor EDC systems. “One of the biggest pain points for industry is still delayed data entry. And after working in a clinical research office for a number of years, I know that one of the biggest pain points for us is data entry and delayed data entry. The EHRs that we all have hold a lot of discrete data that is critical for clinical research—lab values, AEs, SAEs, medications, medical history, things that we enter individually on patients every time they go on a trial. Why can’t we find a way to connect those systems so that data is automatically moved from our EHR system to the EDC system? There’s potential to do this in a pilot setting for multi-center studies, where centers like the four of us here [on the panel] can collaborate on a clinical trial and see if we can connect this data through an EHR to an EDC system. Then the long-term vision, if this is successful, is to collaborate and coordinate with industry to transfer that technology across their trials, as well” he said.

Both Snyder and Innes highlighted how these benefits extend to all players involved in the clinical trials process and the ways in which system integration could save time and resources for “boots-on-the-ground” research staff. “There’s so much potential in managing and structuring information into actionable and usable analytics… From my perspective as an administrator, just seeing the reduced burden for my staff and helping them manage their day-to-day workflows sparks my interest” said Innes.

Progress Continues

All panel members agreed the potential benefits of DIRECT are enormous, but there’s a good amount of work that still needs to be done to make this happen. At Forte, we will continue to collaborate with consortium members to develop a successful infrastructure for future phases of the initiative.

After years of envisioning a more efficient research industry, I’m excited to see the vision for a connected clinical trial ecosystem become more and more of a reality. As the DIRECT initiative continues to progress, we take greater strides towards more efficient and higher quality clinical trials. Learn more about DIRECT and the necessary steps to make this vision a reality, register for our free, upcoming webinar, “Steps to Transform Clinical Research Through a Site-Centric Approach”. 

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