Why Is Study Build in Clinical Research Still Taking So Long?

clinical trials, electronic data capture, EDC solutions

The Tufts Center for the Study of Drug Development released its 2017 eClinical Landscape Study last month, and among the results is a troubling statistic: Companies conducting clinical trials are taking an average of 68 days to build their studies, with 77% of survey respondents reporting problems entering data into their electronic data capture (EDC) solution.

This comes at a time when EDC has grown into a robust industry, with a whole host of companies working to create innovations that have unlocked capabilities that early developers of the technology never imagined. These innovations are purported to make EDC more flexible and efficient, and to accelerate clinical data management as a result. So why is the average average study build timeline still hovering at over two months?


At the root of the EDC usage issues

Among survey respondents who reported issues entering data into their EDC, the majority cited either integration issues (34%) or technical demands on support staff (29%) as causes. Both of these concerns are on our minds a lot here at Medrio, to the point at which we’ve centered much of our functionality around mitigating them. Let’s take a quick look at each, exploring some of the details and their pertinence to clinical trials today.

  • Integration – It wasn’t long ago that the vast majority of clinical trials were beholden exclusively to paper in their clinical data management. Now, it’s common for trials to use not only EDC, but numerous other electronic systems like CTMS, IRT, and more. The ability of those systems to seamlessly communicate with one another is essential for the efficiency the industry demands and to ensuring that clinical trial technology doesn’t in fact create more delays than it eliminates. Survey respondents cited both cost and effort as the sources of their integration issues.
  • Technical demands – About half of those who experienced this issue cited demands on external support staff, specifically, as the root of the problem. This points to an issue we’ve long recognized at Medrio: the cost, delays, and general headaches that come from having to coordinate with external programmers for functions like study build and mid-study changes. The other half of these respondents cited demands on internal support staff, pointing to another aspect of the issue: Clinical researchers should, of course, be free to focus primarily on clinical research – if too much of their time is spent dealing with the technological side of things, something is wrong.


What’s at stake when it comes to slow study build

The EDC usage issues that contribute to slow study build times can also lead to a variety of delays throughout the data management process. It can extend the time that elapses between a patient visit to data from that visit being entered into the EDC, and in turn slow overall progress to database lock. Both of these are touched upon in the Tufts report.

But perhaps what’s most alarming about the report’s findings is that they’re ultimately avoidable. Medrio developed our drag-and-drop process for study build for the express purpose of reducing reliance on programming and IT staff and keeping study build in the hands of clinical data managers. As a result, we’ve seen studies built in as little as one day. And the APIs that help integrate Medrio with other systems are free, so users can streamline their transmission of data from one system to another without incurring extra costs. This all stems from a simple reading of the direction in which clinical research is headed: As trials continue to become more complex, the efficiency unlocked by these resources will only become more valuable.