From The Editor | October 23, 2024

Plodding Toward Better Data Integration & SSO

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By Dan Schell, Chief Editor, Clinical Leader

Laura Hilty
"If you are offering some type of SSO, but sites still have a bunch of duplicate data entry, you’re not solving the whole problem,” says Laura Hilty.

Have you heard about this new platform that enables sites to use their preferred — even proprietary — data collection technologies and offers a true single sign-on (SSO) that eliminates all other passwords, and seamlessly integrates EHR data into their EDC?

Yeah, me neither.

Sure, there are lots of companies out there today touting various one-portal-to-rule-them-all solutions and whiz-bang SSO and EHR-EDC integration apps, but let's face it, none of them are living up to their hype. Duplication of data is still rampant, and password management — even for some sponsor emails — has become the bane of many CRCs.

Laura Hilty is no stranger to hearing about the woes of sites. Currently, she is a principal at HealthX Ventures a digital healthcare-focused venture capital firm, but previously she had worked at Advarra and Epic. In whatever her role, I'd say she is an advocate for helping sites become more productive and efficient. She gave a great presentation two years ago at the Innovation Network Gathering conference that highlighted some of the struggles sites have with sponsor technology, which can create innovation bottlenecks for clinical research. “I was really encouraging sponsor-facing systems to integrate with the site systems to ease the burden on the sites,” she recalls. “It’s interesting, now that I'm at a VC, I'm seeing that those tech vendors who try to “boil the ocean” and become a single platform — they don't make it.”

Whenever anyone starts talking about an “integrated ecosystem” in clinical trials, the subject of SSO rises to the top of the conversation — and maybe, justifiably so. These days, site personnel can get burned out quickly, especially when part of their day-to-day job is simply remembering which systems were used on which studies and what passwords go with each application. The stress can be overwhelming and frustrating.

Hilty notes that there are some SSO solutions at academic centers/health systems where they use their local LDAP (lightweight directory access protocol) or something similar that works in conjunction with their EHR and/or internal applications. There are also some SSO systems that are designed specifically for sponsors, but not sites. “If you are offering some type of SSO, but sites still have a bunch of duplicate data entry, you’re not solving the whole problem,” she says.

WILL LARGER SITE NETWORKS HELP?

With all the scuttlebutt about the rise of site networks and patient access organizations (PAOs) as well as PE firms (and CROs) investing in site networks, I was curious if this shift in the power dynamic could help “move the needle” on a more integrated tech ecosystem or even just SSO. Hilty says from a big-picture standpoint, this trend is a good thing considering traditionally, “sites have been treated less than stellar — and arguably not fair — which has a negative effect on clinical research and its participants.” She believes the conglomeration of site networks could help the large ones to increase the voice of the sites and help drive changes that will ultimately ease site burden.

3 THINGS HOLDING BACK EHR-EDC INTEGRATION

When our conversation turned to EHR-EDC integration, Hilty was quick to say she believes the following are three points about this topic that aren’t often talked about:

  1. Even for trials that have the most potential for EHR data like oncology, only 50% to 60% of the EDC data comes from the EHR, and of that, there is less structured data. This is where I see an opportunity for NLP (natural language processing) and AI capabilities as they mature. Using those technologies, you’ll be able to populate the EDC — in a more accurate way — with unstructured data. Of course, someone still needs to review that data.
  2. A lot of the current solutions have been trying to connect to EHRs at the beginning of the study. But in AMCs, which hold a lot of that data, there's just a lot more bureaucracy. You can't do it [integrate] quickly. There are a ton of security reviews because of a fear of cyber-attacks. When I was at Advarra, they had an EHR-EDC integration for academic centers to run investigator-initiated studies. But to go beyond the FHIR (fast healthcare interoperability resources)-based structured fields, it is a lot more work, and the AMCs have to trust the data.
  3. There’s also the data-mapping issue. For example, each health system that implements an EHR chooses slightly different ways to implement it. So, you almost need a mapping exercise potentially at the site level, but then some at the study level, as well, to figure out how to map the fields.

Like Hilty, I’m optimistic that the slow pace we’ve been on regarding better integrating platforms and point solutions will speed up, and SSO will piggyback on that progress. Why do I feel that way? Because we can’t go backwards, and we all know that these issues are just some of the many bottlenecks in our current clinical trials process. Somehow, for the sake of the patients seeking these new therapies, we need to figure out more ways to work together — and more efficiently.