Can You Afford Not To Go Electronic? (Part 2)

12 January, 2015, by ClinCaptureTeam

Selling EDC to the Checkbook Holders

If your company should be using EDC but isn’t, how can you help to seal the deal? Case studies are always helpful, as they can provide examples of the savings that can be realized. It may seem free or cheap to use paper, but you need to get management to look at the cost of increased labor time when using paper vs. EDC (data entry, query management, etc), as well as to evaluate the cost of using that data later or how errors and corrupt data can affect the study. When you use EDC the total costs always end up being significantly less, and those savings will compound when doing additional studies.

Some people will always resist new technologies simply based on risk/reward and the return on investment. But those arguments are getting easier to overcome as the costs of an EDC implementation head towards zero. Rather than taking three years to recoup an initial investment, companies are now able to do it in a week. You can now start a trial, build your CRF on the vendor’s system, add complex rules if necessary, and do all of that for free or a very low cost. The labor it will take to do that is also significantly lower than the labor it would take to manage it on paper. Taking that kind of a proposal to management is almost a no-brainer because in many cases you won’t even have to ask for a check. It is no longer a funding issue. It is a data quality and efficiency issue. There are really no longer any reasons for someone not to go electronic.

A Look into the Future

In ten years I envision for every study, key personnel signing into a single secure system, looking at trial documents and the trial management system, checking up to the minute total spending amounts, and viewing real time outcomes and analytics data from studies in progress. This view into the data will allow them to know much sooner in the process whether and when a study should be cancelled. This will potentially save companies millions of dollars and allow them to focus personnel and other resources into trials showing the most promise. The seamless integration of applications on an open platform and providing secure access to the collected data by any of the programs will be inherent in the system.

All of that information will be on a dashboard and available to approved personnel at the touch of a finger. This is actually not that hard to do in a cloud environment with open APIs and where developers can build applications on robust platforms. When you start attracting people to a new paradigm and hit a critical mass of users and data, it suddenly becomes worthwhile for developers and companies to enable other applications on it. That is something we will continue to try to make into a reality.

Finally, it is important to note that technology is not at a standstill. In the last 10 years we have seen significant changes in technology. Going forward, we will continue to see new technologies hit the market. Smart phones and tablets will continue to play a greater role in clinical trials for mobile and off-line data entry. An explosion in wearable monitoring devices such as sneakers, wrist bands, and even clothing, in addition to things like web-enabled scales, will continue to be a strong lure for both consumers and clinicians. I believe the quantities of data generated and gathered will be much greater, making it a crime for life science companies to not take advantage. Unfortunately, for that to happen, regulatory agencies will also have to figure out how to best make those devices a part of the trial process.

Right now you can’t use invalidated devices in a trial, which I believe will lead to some interesting debates. If you’re doing a study on diabetics who need to weigh themselves every day, will they be able to get on their web-enabled scale that will automatically upload their weight into a system or are we going to have to go with the less robust method of them reporting their weight by paper or by phone? Will we get accurate weight data or have to continue to worry about patients making up the numbers or not performing the weigh-ins at the proper times? Technology can alleviate those situations and deliver better data, but we need the regulatory agencies to step up and make decisions on what will and will not be allowed.