Don't miss Part I of our series: "The Coming Wave of eSource and eReg Adoption"
Clinical Research IO (CRIO) was founded on the belief that we can get life-altering drugs to market faster through the digitization of health care. We think there are already several worthy technological solutions in the marketplace that can have a meaningful impact for research sites and trial sponsors. Unfortunately, the landscape of technology offerings is cluttered and disparate, and clinical research sites in particular lag behind the industry in terms of tech adoption. We set out to discover why.
In March 2018, CRIO commissioned Insightful Alliance, a market research firm, to administer a 37-question web survey. Managers at roughly 3,000 research sites were solicited, 118 responses were received, and all responses were anonymized to CRIO. Here's a breakdown of the survey respondents:
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Research sites spend less on IT than the health care sector as a whole
We mentioned this in Part I of this series, but it's worth repeating here. Physician practices are the only type of research site that reports spending as a percentage of revenue close to the industry average. However, given the relatively low adoption of research-specific software within this segment, it's unclear if these practices truly invest at this level, or are merely reporting their spend as an allocation of their overall EMR budget. Non-physician practices report spending significantly less than the health care sector benchmark, suggesting an opportunity to make further investment.
Now let's focus on the research site workflows for which CTMS software was built: patient recruiting, scheduling, and financial management.
The choice of different software solutions varies widely by site type
CTMS has much broader adoption than newer research software solutions like eSource and eRegulatory. Plenty of sites, however, still use general software like Excel and Outlook, as opposed to industry-specific software like CTMS. As with source and regulatory workflows, freestanding research sites are the strongest adopters of industry-specific software for recruiting, scheduling, and finance. These sites are unencumbered by non-research workflows (like a physician care practice) and focused solely on research operations, which may explain higher CTMS adoption.
Electronic Medical Record (EMR) usage is the most pronounced difference between freestanding sites and hybrid or dedicated practices. Since hybrid and dedicated practices are already using the EMR to manage patient care, a natural next-step is to use the same EMR system for recruiting and scheduling in their clinical research as well.
While general software can be used for any of the CTMS workflows, finance is the only workflow in which general software dominates. Microsoft Excel was released in 1985, but there's a reason it's still used by over half a billion people worldwide. Although Excel doesn't integrate with other research software systems, its users are just as satisfied using it for finance workflows as users of CTMS, shown below.
Users are generally more satisfied with industry solutions (CTMS or EMR)
For uses besides finance, CTMS and EMR users report significantly higher satisfaction with their software compared to users of general software like Excel or Outlook.
The EMR offers benefits for hybrid and physician practice sites who are also using it for patient care. Not only are those users already familiar with the EMR interface, but they also have study participants' medical histories already in their research database, so research staff skip a manual input process.
CTMS software can offer research-specific features that general software simply isn't designed for. For example, when scheduling patients for study visits, the visit eligibility window can be displayed right on the calendar, so staff don't have to refer to any other documentation. The patient database and visit schedule exist in the same system, so there is no need to switch back and forth between calendars, emails, and spreadsheets. An effective CTMS also enables easy patient outreach, automatically logging all staff actions and patient responses.
CTMS can address the shortcomings of EMR and general software
When it comes to recruiting, EMR users' most common complaint is with the EMR's poor search functionality. Search is one of the core components of any quality CTMS offering - not a single CTMS user in our survey complained about search functionalities.
For scheduling, half of the dissatisfied general software users (again likely Excel and/or Outlook) cited "integration with other systems" as the top gap in their solution. A major advantage of using CTMS software is that one true data source is shared across recruiting, scheduling, and finance workflows. eSource enables an even deeper level of integration, whereby source data automatically updates CTMS data like patient information and invoiceable items.
"Ease of Use" was cited as a top gap by dissatisfied users of all three software types. Clearly, usability is a top criterion for any frequently-used software solution. Luckily, several vendors offer newer, well-designed CTMS products that are user-friendly and easy to learn.
Familiarity with incumbent systems like Excel, Outlook, or an EMR is a chief reason their users are reluctant to switch to a CTMS, despite the functional benefits. A CTMS that offers both fluid integrations and an easy-to-use interface can be well worth the switch.
CTMS software can offer research-specific features that general software simply isn't designed for. See the unique features CRIO's CTMS offers.
Author: Bob Bedetti collaborates with the Sales and Marketing teams at Clinical Research IO to evangelize the digitization of clinical research trials. He enjoys learning from people across the health care industry in CRIO's search for ways to get drugs to market faster. He is currently an MBA candidate at Harvard Business School.