Electronic Data Capture Systems In Clinical Data Management: The myths and the reality

This post is a guest blog written by David Tashjian from Clear Clinica. The views and opinions in this post are not representative of Quanticate. By publishing Guest blog posts it does not imply Quanticate has a working relationship with any companies associated with a post and we are happy to receive guest blogs from any industry related company.

 Electronic data capture (EDC) is no longer a clinical study unicorn, but there is still a bevy of misconceptions surrounding the move from traditional, paper-based clinical data capture to EDC. We can only expect as much, being that EDC technology (and especially cloud-based systems) is relatively a recent addition to the clinical trial industry.

At this point in the timeline of EDC, the technology is old enough to no longer be novel, but still too young to be embraced as the next industry standard. EDC is caught somewhere between the frontier and business as usual.

In just 15 short years, the use of EDC in clinical trials went from almost 0 to 75% of studies using some form of electronic clinical data management, whether on-site or cloud-based (full disclosure: we overwhelmingly support the argument for cloud). However, 75% is not 99%, and there are still a quarter of all clinical studies relying on paper CRFs and Excel spreadsheets.

Change is good, but change can also be tough and requires ample time for adjustment. For the 25% of clinical study sponsors and clinicians accustomed to paper CRFs and such, overhauling the method used for data collection and monitoring can seem pointless.

If it ain’t broke, don’t fix it.

Not that paper-based data capture is an entirely broken system, but EDC absolves studies of much of the erroneous data capture and compliance adherence inherent in a paper-based model.

Today we are going to address the fallacious myths surrounding EDC and why they should be dismissed.

Myth #1: EDC is expensive

Reality: EDC saves on study costs

While some EDC systems can be rather pricey upfront to install, train staff, and implement, the overall cost savings study after study cannot be underlined enough. Sponsor ROI for switching to EDC is well worth the initial investment.

The assumption that EDC is expensive is a remnant of the early history of EDC. When the technology was first birthed, as with anything first generation, the more capable the system was the more expensive it was; cheaper EDC systems were lacking in many features study sponsors were looking for. However, that is no longer the case, with dozens of reputable EDC vendors now available, all competing to out-perform the other guys at the most attractive price point.

Myth #2: Switching to EDC takes too much time

Reality: EDC saves precious study time

While this may have been true when EDC for clinical trials was first being rolled out, it is an entirely moot argument today. Take into account that 80% of the time and money spent on pharmaceutical development is spent on conducting clinical trials, due to how heavily regulated the industry is. Not only does EDC allow for an attractive cost ROI, but time ROI as well.

Consider that most clinical studies last for at least several months, many for years. Switching to EDC saves on average 30% of the time it takes to conduct a clinical trial. If you are saving 30% of the months spent on a study, how significant are the few weeks spent to train staff on how to first use EDC? Not very.

Further, once your study team (and patients for subject-submitted data studies) are trained in using the system of your choosing, new studies year after year are able to get up and running with less time for preparation. ECRF templates are easily modified to suit each new study, saving the time on designing and producing paper CRFs. On average, EDC cuts 41% of pre-study preparation time.

Myth #3: Data stored in the cloud is unsafe

Reality: cloud storage is significantly more secure than on-site and/or paper

Everyone has heard the urban legend horror stories of identity theft, bank accounts getting hacked, etc. While there is always an exception to the rule, data storage for the vast majority of cloud systems is protected with robust and redundant security protocols against theft, loss, or corruption of integrity. EDC vendors use state-of-the-art technologies to ensure when data is collected, it is secured, and an audit trail is in place in case of accidental edits to the data.

Myth #4: EDC is only for massive Phase III+ studies

Reality: studies of every size can benefit from EDC

While EDC was first developed with larger studies in mind such as phase 3 clinical trials or later, there are systems available to match every varying degree of study simplicity or complexity. Of course, the longer the duration and greater the number of variables measured will demonstrate the undeniable value of switching to EDC.

However, EDC systems are notoriously customizable. If your next clinical trial is going to involve more or less data than the previous study, your EDC vendor can work with you to customize the system as needed, so your team does not need to spend time and effort to source another vendor.

What are the possible drawbacks of EDC for clinical data management?

Honestly, we cannot imagine a single scenario where EDC does not beat out paper-based data management in terms of increased savings on time and money, enhanced data security, and software customization. EDC is even “green” in comparison to traditional data capture methods, entirely eschewing paper forms. Now that we have addressed the common EDC myths, share with us in the comments below what you feel are the most valuable aspects of EDC. We would love to hear from you.

Quanticate’s Clinical Data Management team has a wealth of experience in managing studies in various EDC platforms and also conducting paper-based studies for our customers. If you would like more information on how we can assist your clinical trial submit an RFI.