Electronic data capture for clinical trials is a multi-billion-dollar industry1 that has brought demonstrable benefits to all phases of clinical research. Still, the portion of clinical trials collecting and managing their data on paper is too large to ignore. As recently as 2015, Open Health News reported that less than half of all new clinical trials were using EDC. And while researchers continue to sift through file cabinets and manila folders, the eClinical industry is roaring forward with cutting-edge refinements and developments like eSource, randomization, RBM, and more. With EDC creating new potential for shorter timelines, budget savings, and easier data management every year, why do so many clinical trials still limit themselves to paper-based data capture?
Old habits die hard
To be sure, in some cases, such as clinical research performed in the developing world, the continued reliance on paper is difficult to avoid, owing to factors such as the perceived higher costs of EDC. But in other cases, it is, in fact, a matter of choice. To many veteran clinical researchers who have grown comfortable with paper-based data capture, EDC can appear as an unnecessary technological burden, one that requires a tech-savviness they’ve never needed before and may not possess. It may also raise concerns related to job security, eliciting parallels with the automation that has affected much of the workforce in recent years. In a case study we published last year, a consulting firm working with Medrio noted this mentality as a significant impediment to more widespread adoption of EDC.
It would be misguided to view reluctance to adopt EDC as a matter of simple stubbornness. A fundamental change in the nature of one’s work is, indeed, daunting. And many EDC vendors do impose a burden on users during implementation, requiring programming and offering an interface geared more toward tech experts than clinical researchers. Rather than demand new skillsets and technological experience from users, the burden should be on the EDC vendor to make the transition away from paper as smooth and natural as possible.
Accessible EDC through better support
With this in mind, one of Medrio’s biggest mandates is to be universally accessible. Perhaps the most fundamental manifestation of this goal is the absence of required programming: Users neither need to possess a skillset outside the domain of their profession nor hire coders to set up their software. Beyond this, though, Medrio addresses reluctance toward EDC adoption with a particular focus on training and support. Through training sessions offered both onsite and via teleconference, extensive customer support availability, and complementary training for members of Medrio’s Partner Program, Medrio aims to acknowledge and appease the concerns that have closed off many researchers from modern methods of data capture.
Research suggests these are wise investments. Insufficient training has been cited as one of the barriers to more widespread adoption of EDC.2 And as the technology evolves, there are more people to train and more features and tools to train them in. Data managers, for example, may be comfortable with EDC but not yet familiar with the latest technology for adaptive study designs. At the sites, staff working on EDC-equipped studies may still use paper to collect source data, but the advent of eSource is changing that.
The intention of EDC is, of course, to catalyze and simplify clinical trials. Requiring users to invest great time and effort into becoming fluent in their software would defeat the purpose entirely and legitimize the resistance to technological change that has kept portions of the clinical research industry reliant on paper-based data capture. To bring the efficiencies of EDC to these holdouts, vendors must show them that the technology doesn’t necessarily represent such a burden, that with solid, convenient training and an intuitive interface, it can be accessible even to the industry’s paper veterans.
1 Reportlinker; Global E-Clinical Solution Market Size, Share, Development, Growth and Demand Forecast to 2020 – Industry Insights by Type, by Products, by Delivery Mode by End Users [press release]; PR Newswire; 3 Feb 2016
2 Parekh, Sameer; Electronic Data Capture in Clinical Trials: Does the emerging world still lag behind in EDC adoption?; Applied Clinical Trials; 1 September, 2013