ETM: The Next Frontier

With all the attention being paid to new electronic data collection alternatives, or which clinical data management system should we migrate to, the stepchild of clinical research software, electronic trials management (ETM), continues to be underfed. This is not for a lack of trying: many sponsors have been working on their own systems for years or implementing vendor products, and CROs/SMOs are certainly aware of their need, but have been frustrated by the cost (in dollars and time) of implementing solutions which are ultimately unsatisfying.

At the recent Executive Forum on Electronic Trials Management, sponsors, vendors and service providers gathered to discuss these critical issues. The problems (or needs) fall into two buckets technology, and process. The former, it turns out, is always easier to fix than the latter.

In technology terms, current ETM software exhibits a lack of focus on who the true users are (and there are several, all different). The result is a hodgepodge of products which, when implemented, seem to serve the needs of a few and aggravate the many. The market’s frustration, expressed in many phone calls to us, is that be they sponsor or CRO or SMO, they can’t seem to find the right product for what they want to do. Part of the reason is that ETM is a very broad field, and probably needs products that are more modular and tailored.

Both sponsors and service providers appear evenly split between those who have gone to a vendor product and those who decide to write their own. There are strong arguments on both sides, but ETM can mean something so unique to a company that building your own makes sense. Any number of platforms are apparently equally effective Oracle, Notes, SAS, Microsoft.

What we heard at the Forum, and hear from customers repeatedly, is how critical it is for ETM functionality and data to be integrated with the other clinical research software components EDC, adverse event reporting, CDM, lab information, patient recruitment. Very few vendors even begin to offer such integration or know how to help you achieve it.

Process Issues at the Core

The people, political, and logistical obstacles to effective use of ETM are more problematic than the technology questions. Sponsor initiatives fail the most when the ETM program is designed to only feed information to upper management, without giving anything back to those down below entering the data. This is a surprisingly common error, producing powerful negative feedback. Upper management is pleased at the aggregated reports they are getting from the system, while those actually in the trial trenches say that those reports are inaccurate and out-of-date. Why? Because the application doesn’t provide the end user what they need in their daily work, greatly reducing their incentive to enter accurate data on a timely basis.

Another source of failure within large sponsors comes from the nature of the problem ETM is trying to solve to provide interdepartmental aggregated information. This means the application crosses the “silos” of clinical, monitoring, data management and safety. If your company’s silos have thick concrete walls, their willingness to participate in the successful design, implementation and use of ETM will be severely diminished.

These two problems, and many more like them, lead to a huge price tag in dollars and time for implementing an ETM application. Several sponsors report very high costs and years of effort. If the design and implementation of the application was seriously flawed, this is a embarrassing waste. And worst of all, if it takes too long, the application’s technology base will be obsolete by the time it’s implemented.

Service providers have some different challenges in adopting ETM. First, in many ways ETM is even more critical to them than to sponsors. Trials management means business management to a CRO or SMO, and so they are thinking about proposal management, billing histories and scheduling as much as they are about enrollment and data quality. The possibilities of value for a fully integrated application to a CRO or SMO are incalculable, and yet almost all such companies are reluctant to spend the money necessary to build a necessarily complex mission-critical application. Some public CROs still run their business on spreadsheets; it might work, but what’s being missed is enormous.

Why ETM Anyway?

Sounds like ETM is a difficult challenge: too many kinds of users with too many different needs. Why shouldn’t it stay a stepchild? Because ETM is at least as important to Time to Market as other research technology initiatives.

A month saved is a month saved, whether that month comes at the beginning of the project or at database lock. Knowing your progress in patient enrollment, the data quality level from different sites, where study drug supply should be and when, which monitors or CROs are underperforming, are critical to timely trial completion. This information needs to be known in as real time as possible, and only an electronic means can make that happen.

The lessons learned indicate that sponsors need to simplify their ETM efforts and ensure all users benefit; service providers need to spend enough money to get the value awaiting them. Both constituencies need to bring ETM out of the shadows and focus their creativity on using technology to gain control of their trial programs.