Can You Afford Not To Go Electronic? (Part 1)

5 January, 2015, by ClinCaptureTeam

With the technology advances we have seen in the last 10 years, and changes that we continue to see every day, it’s hard to believe that, worldwide, only around 20% of clinical trials are using electronic data capture (EDC). The other 80% of data is still being captured on paper or in Excel spreadsheets. With any luck, in ten years we will see 99% of trials capturing data electronically. Many changes are occurring which will enable that to happen, but life science companies will need to educate themselves on the changing landscape.

Of course the first question you have to ask is why the low adoption rate. The answer lies in perceptions about the cost and complexity of migrating to EDC. Barriers that existed in the past could generally be navigated by large pharma companies that had the money and manpower to overcome them. For startup life science companies, it was a different story. They did not have the knowledge, the resources, or the budget to move to electronic trials. The situation has now changed, and the reality is that it is almost always cheaper to capture data electronically than to do it only on paper. However, misconceptions still exist in the market. Going forward, education and better access to available tools will allow them to take advantage of EDC as well.

Lower Cost, Greater Ease of Use

Cost is the first factor that will help the industry get to the 99% acceptance rate. In the past, the price of an EDC system varied widely, but you always got what you paid for. If you purchased a cheap system, you generally found yourself lacking in features. That forced companies to purchase more expensive systems to get the functionality they needed. The advent of the Internet and cloud capabilities has changed all that.

EDC software with the same capabilities as the more expensive systems has come down in price dramatically. In some cases, the software is even free. This has happened for two reasons. The costs for supplying cloud software are far reduced from the traditional licensed delivery model that existed in the past. Today we also have a validated regulatory environment in the cloud, whereas in the past companies had to establish their own data center and validate it at a high cost. All of this is causing a dramatic drop in the initial entry cost (the license and startup cost) for starting a trial.

In addition, new tools have been emerging that allow companies embarking on trials to do a lot of the work themselves. In the past pharma had to pay a CRO, software vendor, or other professional services provider to perform functions such as changing case report forms from paper to electronic. The trend now is to provide free or inexpensive software along with do-it-yourself capabilities that allow even small companies to do much of the work themselves. In most cases it costs less than doing the same work on paper.

Driving Adoption in Pharma

Even with the cost benefits, the conservative nature of pharma means most firms won’t be lining up to implement new systems. In bigger pharma companies, buy in will generally occur at the management level and then get driven down into the company. In smaller companies, the growth of adoption will likely be more organic, as those companies will not be able to afford not to do it. As they adopt the most cost efficient technologies and most economical methods, their actions will likely drive greater adoption in the larger companies that are traditionally more stuck in their ways. To put it simply, the larger companies should be doing it, but the smaller companies will have to do it.

There will certainly be a role for CROs to assist with the adoption of these technologies as well. Sponsors will often tell their CROs how to perform studies and what tools to use, but more and more CROs will implement technology advances on their own in order to better serve clients. If a CRO is making use of a cloud-based technology that is free of charge, they can pass those savings on to the sponsor. With CROs responsible for about 50% of studies in the U.S. alone, those changes will obviously have a huge impact.