Guest Commentary: The New Software User Paradigm for Electronic Data Capture
By Martin Young, senior vice president, integration and product strategy at Phase Forward
In the evolution of software there often comes a point when an application’s original utility is no longer novel but has instead evolved to become the common method for performing the task it was designed to simplify.
Through continual use, operators of the software become adept with its capabilities and push the boundaries of its functionality and initial intent. Related tasks, and tasks that previous to the use of the software were not connected, or arose as a result of the use of the software, logically become tied to the application. This dynamic, reflexive relationship between user and software ultimately creates a new user paradigm in which the original design of the program is inadequate for its current purposes. Such a transition has occurred in the evolution of electronic data capture (EDC) technology as it is applied to drug development activities.
Today’s clinical trials are more complex and longer than they were just several years ago, requiring the management of much larger volumes of information. Some of this complexity comes from the interwoven pressures on the pharmaceutical industry, the increasing global nature of many clinical trials, and the proliferation of electronic data sources (including EDC, interactive response technology, electronic patient reported outcomes, etc.), but it also stems from the success of EDC itself. As users became more comfortable with the technology, they were able to apply its efficiencies to new areas of clinical development and accommodate new data sources.
The increased numbers of subjects, sites, visits, forms and queries that need to be captured and analyzed in a clinical study, however, have made the jobs of EDC users more difficult than ever before (as one might expect) and unearthed limitations to traditional EDC interface designs. Software designed five or more years ago is not really relevant to how clinical trials are conducted in 2009 and does not account for the elevated ability of today’s increasingly sophisticated users—both from their experience with the software and the ubiquity of the Internet and computer-based technology.
Clinical research coordinators are using EDC across multiple trials and sponsors (often geographically dispersed and conducted in multiple languages), and need to stay on top of what needs to be done, while balancing different processes and expectations. Clinical research associates are looking at wide swaths of data and need to be able to quickly see what requires attention, not just what has been done. And data managers working with huge sets of data need to viscerally understand what is happening in a trial and what has changed. EDC software with an interface that has not evolved to address these needs runs the risk of becoming outdated and a burden to its users.
Because today’s clinical professionals are so proficient with EDC and related technology, there is now a great opportunity to rework how they interact with the software and to integrate the multiple electronic data tools into a single technology suite that accommodates a seamless interchange of data. When working with such large sets of data, it becomes vital for important information to stand out from areas of the user interface that aren’t conveying any information. Likewise, grouping information in a useful and meaningful way to allow users to make fast conclusions about what is happening will drive workflow. The result should be queries that are resolved quicker, errors that are reduced, and the streamlining of the progression of documents and forms, as well as task delegation, from employee to employee (or from sponsor to site as is often necessary in clinical studies).
Users of EDC have borne the brunt of a lot of the industry pressures that have manifested in clinical trials. New and innovative ways of delivering functionality to end users are critical for this technology to continue to deliver value to its end users, trial sponsors and, ultimately, the public at large that wants access to better and safer life-saving medicines and treatments.