EDC is Off the Back Burner: Is the Right Dish Being Cooked?

For those of us who have worked for many years to help the industry redefine clinical data processing, it is highly gratifying to see substantial interest in electronic data collection (EDC) not only spreading broadly across the industry, but also creating an air of “inevitability” for EDC use. As we sit down to our holiday dinners, I worry that now that EDC is off the back burner, do its purchasers think of it as the grand turkey in the center of the table, or the acorn squash in the corner that only the more adventurous health nuts make room for?

Do companies now laying plans to adopt EDC really understand what EDC is, and what it really allows them to do?

Understandably, EDC acquisition or use decisions are usually made by, or involve, clinical data managers, IT personnel and regulatory staff. These folks usually bring to the table a structural picture in their mind of clinical data processing — a picture which is “CDM-centric”. In this picture, EDC is only a moon orbiting the CDM sun, along with other moons, like trials management and adverse event systems, and asteroids like drug supply logistics and site communications.

This approach will set back the adoption of EDC many years. Why? For at least 5 key reasons:

Today’s EDC tools are moving closer to full CDM and ETM (electronic trials management) functionality.

As EDC use increases (and its functionality broadens), CDM’s usefulness is increasingly marginalized.

A CDM-centric approach, to have any logic at all, would require study designs to be built in the CDM application, none of which are designed to take advantage of the process and usability improvements EDC applications bring.

Dramatic improvements in drug development depend entirely on sponsors becoming Site-centric, which a continuing focus on CDM prevents.

Clinical staff, and sites themselves, must become equal, if not greater, partners in the design of any sponsor’s next clinical data processing system.

What is the basis for my concern? Recent industry meetings, while gratifyingly filled with EDC stories, indicate sponsors are using it marginally, without applying adequate resources, or assuming it should be limited to a handful of trials, or show a reluctance to use EDC technologies which stray more than a step or two from paper.

I am also concerned for the vendor community. Our recent report on the EDC market, now available to the industry as a whole, reveals dozens of groups attempting to provide sponsors with an “off-the-shelf” solution for EDC, but even those who “deserve” to survive cannot possibly do so if sponsors think of their offerings as a side dish.

A picture for the future of clinical data processing would look more like the following: A data warehouse underlies all clinical development applications, whose interfaces to all users share a common look-and-feel. The dominant application sitting on top of this warehouse is electronic data collection (now encompassing many traditional CDM functions, including study design and CRF standards, coding dictionaries, query management, and even a path for entry off of paper CRFs). This EDC application is wrapped in an ETM envelope, deriving data from EDC and sister applications, feeding the data warehouse, so that management can have a single integrated view of the progress and quality of the trial, the danger signs, the unexpected good and bad news. In this picture something akin to traditional CDM remains, but is used only for specific, limited, reporting and export functions feeding analysis and submission.

Why should sponsors hang this new picture in their dining room? Because it is only through focusing on what happens at the site, and involving the clinical operations staff in accelerating that activity — recruitment, evaluable patients, rapid identification of problem enrollment or poor CRF design, keeping to the study schedule, and real-time data cleaning which will lead to rapid database lock, timely decision-making, and compressed development timelines. EDC is the catalyst (not the answer in itself) to this crucial process change.

It is in this context that a sponsor’s strategy for adopting EDC must be considered, and potential vendors subsequently evaluated. To view EDC as a satellite to CDM will hobble EDC’s contribution to accelerating drug development and lead to inevitable disappointment in its ROI. To view EDC where it belongs, as the trigger to a clinical data processing re-design, is the key to realizing the benefits that have long been promised but rarely realized.

Make sure you give electronic data collection and trials management the right opportunity to shine at your table. It is the main dish: prepare it correctly and you will feast on the results.