How EHR-to-EDC technology is sparking better collaboration in clinical trials

March, 2024
How EHR-to-EDC technology is sparking better collaboration in clinical trials

Joe Lengfellner is Senior Director, Clinical Research Informatics at Memorial Sloan Kettering Cancer Center (MSK). Here, he talks about how EHR-to-EDC projects, including MSK’s collaboration with IgniteData and leading sponsors, is sparking a new wave of cross-industry collaboration.

I’ve spent the last 15 years or so immersed in the data requirements of clinical trials and, up until the last few years, the lack of meaningful collaboration across the different players in the industry was a source of frustration for many I know. Certainly, we saw consortiums of sponsors come together to address shared challenges. We also saw many research site consortiums and collaborations. But wider cross-industry collaboration was sorely lacking.

Over recent years, however, this dynamic has seen a welcome shift. We’re now seeing much greater cross-pollination of ideas between sites, sponsors, technology partners and regulators, which can only lead to better discussions and better solutions for clinical trials.

Why this shift?

The shift we’re witnessing in the landscape of clinical trial execution is rooted in the acknowledgment that some of the primary challenges we encounter in this domain have shown little improvement and, in certain aspects, have even intensified. A notable issue is the prolongation of timelines for completing clinical trials. According to a 2023 Tufts Center for the Study of Drug Development (CSDD) Impact Report, the mean overall durations of both phase two and phase three trials have increased since 2015. In recent years, there has been a growing realisation that addressing this situation necessitates collaborative efforts to achieve progress.

A prime example of this trend is evident in the clinical trials technology space. Previously, sponsors often collaborated with vendors to select and develop technology for trials, subsequently imposing that technology on sites. However, there has been a significant shift in this approach, with sponsors now exhibiting greater receptiveness to sites bringing forth the technology that suits their needs for the trial. Consequently, sponsors, sites, and technology partners are collaborating more closely to devise solutions tailored to specific scenarios.

EHR-to-EDC has sparked collaboration

The advent of EHR-to-EDC technology has been an important development that’s helped spark this kind of collaboration and opened up everyone’s eyes to the potential benefits. The streamlining of the transfer of clinical trial data from site to sponsor brings such clear advantages to both sites and sponsors that it has encouraged the different parties to work together in new ways to achieve shared objectives. And it’s been a real catalyst for change.

In my role at MSK, where we’re working closely with sponsors to implement IgniteData’s site-to-sponsor solution, Archer, a really strong collaboration has developed between our MSK group and trial sponsors. The core benefits of more efficient trials, less manual re-keying of data, better quality data and reduced errors and queries apply to both sites and sponsors. These benefits were enticing enough to bring everyone to the table to work together.

But the advantages just keep adding up, in something of a virtuous circle of collaboration. As a site, having been involved in this kind of deep collaboration, we now have much stronger connections with our sponsors. We know who to approach within our sponsors’ teams when we have an idea for innovation. So our project to implement an EHR-to-EDC solution has actually led to all sorts of exciting conversations about other innovative spaces we might want to look at together and other ways we can collaborate to solve challenges.

What other kinds of collaborations are we seeing?

This more collaborative approach has included the site team having more input at the earlier stages of trial design, such as the questions included in case report forms (CRFs) and overall design of the study. It has also led to discussions around using data from EHRs to facilitate other portions of the clinical trial process, including automating of site fesability assesments and patient matching to clinical trials. Once the ability to utilize EHR data becomes more automated, it opens up a number of really interesting possibilities.

Widespread benefits

The benefits we’re seeing from the types of close, multi-stakeholder collaborations I’ve mentioned are widespread. Using our implementation of IgniteData’s Archer as an example, there are many beneficiaries. IgniteData benefits from the opportunity to pressure test the technology, add to their understanding of the pain points of clinical trial implementation and co-design further developments. At MSK, we have the opportunity to implement an industry-shifting technology along with partners that are dedicated to making it work for our very large clinical trials program. We’ve started tracking how we’re improving job satisfaction for clinical trial staff who are able to shed the burden of tedious data entry and focus instead on more valuable tasks. Our sponsors benefit, of course, from the added efficiencies and higher quality data.

But it doesn’t stop there. These collaborations are proving to be a great opportunity to bring other stakeholders into conversations. Regulatory bodies, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), are increasingly seeking input into the new methodologies for executing clinical trials, and taking the opportunity to learn from collaborations so they can adopt an informed stance on developments.

Most importantly, our end goal for collaborations like this is always, ultimately, about making improvements for patients. The benefits we are beginning to see from solutions like site-to-sponsor data transfer can only help us make clinical trials more efficient from a time – as well as cost – perspective. This, in turn, means faster access to more life changing treatments for patients. And, at the end of the day, that’s what we’re all here for.

Hopes for a bright future

With these benefits beginning to emerge, I hope we continue to see the level of collaboration we’ve been involved in with site-to-sponsor data transfer, and for those collaborations to continue to grow, strengthen and become faster and faster at rolling out solutions.

In the near future I can foresee a time where the technology advancements mean that the software tools used by sites and sponsors come into line. In this way, rather than us looking at two different views of the same world, clinical trial sites and sponsors can literally be ‘on the same page’.

To ensure this happens, we need sponsors to continue treating solutions such as site-to-sponsor data transfer as a pre-competitive technology, so that the industry can quickly come to agreement on the standards that will be adopted. As it stands, I personally have been in many scenarios where representatives from several different sponsors talk very openly about the work being done in this area. This is encouraging to see and I hope it continues to apply to the further innovations that will undoubtedly follow.

More than anything, I hope – and believe – that as an industry we’re moving towards real action to make progress in how we execute clinical trials. We’re still trying to move this big ship of clinical research in a new direction and what we’re aiming for is a pretty dramatic shift. But the time is now to really move on from academic exercises and discussions about what might work, towards action for the benefit of patients. To my clinical trial colleagues I’d say “Let’s try some things and see them working in the real world.”

Joseph Lengfellner on the challenges and solutions for clinical trials
Joe Lengfellner

Senior Director of Clinical Research Informatics and Technology

Memorial Sloan Kettering Cancer Center

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