There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt for the paper default or the DIY option for monitoring. None of which are a particular good idea.

But – as medical device trials often involve patient reported outcomes (ePRO), and complex data models with 600-900 variables; using paper is not only more expensive and slower but it will require expensive and time consuming data cleaning at the end of the study. The time you spend cleaning data is time you burn cash in your medical device startup and that is much more expensive than using a modern cloud EDC, eSource and ePro for clinical data management.

So – before you look at the nickel in your pocket – consider the benefits of being able to monitor data from sites in real time and stay in control of data quality and patient safety.

The technology is available for paperless clinical trials.  Just not for me

We all feel safer with paper – yes? or no?

Paper-based data capture, the traditional method for performing clinical studies, has been practically used since time immemorial. Many clinical research organizations are familiar with the paper-based methodology, and perhaps follow the ideology of “if it isn’t broken, don’t fix it.” True, while the paper-based system has been used to success for nearly countless decades, there may be a more efficient, less costly system to be exploited for clinical data management during a pharmaceutical or medical device study.

EDC is a minimum but not-sufficient requirement for clinical data management

Electronic data capture (EDC) systems entered the clinical trial industry some 15+ years ago, and came with a lofty promise – trials would be completed faster and at a lower expenditure of resources than in the past. However, while that sounds all well and good, it begs the question of why medical device companies are still conducting clinical trials with paper?

What are the alternatives?

1. Paper – the going rate is about $1000/patient. FlaskData.io list price for an integrated EDC and remote monitoring solution is $25K/year for unlimited patients, users and data.    In a 2 year study this places the break-even point for paper (not including the cost of storage and shipping and the astronomical cost of latency to detection and response to protocol deviations) at 50 patients.  If you have more than 50 patients – paper is a more expensive not a less expensive option.
2. EDC and paper source.  The most common option. Not necessarily the most efficient because you are still stuck with SDV and your clinical trial monitoring costs will sky-rocket.
3. EDC and eSource.   An excellent alternative because it eliminates SDV.
4. EDC and eSource/ePRO and medical IoT.  The future is here. Patients reporting via their devices directly into the EDC. No paper. No SDV. No latency to detection and response to deviations. Reduce costs of clinical trial monitoring  by 90%.

Although EDC systems have been around for over 10 years, only 20-25% of clinical studies conduct their clinical trial monitoring and clinical trial data management entirely electronically. What is even more striking is the comparison with the level of computing in modern transaction processing systems.   Cloud EDC in 2017 is conceptually stuck in the late 80s – with notions of people and paper-intensive processes for monitoring the study.

For the purposes of this article we will be comparing cloud EDC with the paper data capture methodology for clinical trial data management. Let’s get into some of the primary benefits of using cloud EDC.

The pros of using cloud EDC instead of paper

(source: ibm.com)

The promise of more reliable capture of data

One of the greatest features of cloud EDC over paper is the reliability of the data quality. In a paper-based system, data errors can come in every shape imaginable, from illegible writing to absent fields; from misspellings to incorrect recording of patient ID numbers. Study sponsors are tasked with delivering drug, medical device and biotechnology R&D at an increasingly more rapid rate. While aiming to conduct studies in as little time as possible, mistakes can happen.

In a paper-based data capture system for a clinical study, the case report form (CRF) is manually written, which poses many threats to data integrity. A clinician records the patient data and then it is sent to the study monitor, who then needs to review the data and determine the level of patient risk.

Cloud EDC mitigates almost every risk to data integrity inherent in a paper-based system. When using a mobile device or computer for data entry, monitoring logic is in place to ensure that data is free of errors. For example, say a clinician plainly forgets to fill out a field on paper – the mistake is only noticed down the line and then the clinician needs to go back and correct the mistake after the fact. With an eCRF, while studies are being planned and the eCRF is designed, there are safety measures in place to notify clinicians as soon as an entry field is out of line with format, or empty. Also, data is more secure with a cloud EDC system because a form can never be lost or misplaced, which is a historical hazard with using paper forms.

Mistakes will happen even with an EDC system, but as soon as the software notices an erroneous entry or missing data, the user is immediately informed and can correct the mistake. This is especially valuable for studies using patient-submitted data. Many patients are likely not experienced with clinical trials, but with cloud EDC they can follow the logic of the eCRF easily, and will be notified whenever they submit erroneous data.

Further, particularly for studies that are repetitive in nature, eCRF templates can be stored in the cloud for later use. This saves time on not needing to redesign another CRF for a following study.

 Real-time data transmission from clinicians to monitors

The time savings, and financial savings, are profound for the clinical trial manager when cloud EDC is used for clinical data management instead of paper. Study monitors do not need to wait for paper forms to be sent to them – one the data is in the cloud they have access to data the very moment it is entered.

Real-time data access in the cloud reduces the costs of clinical trial monitoring because it reduces the need for physical site visits and in turn enables remote risk-based monitoring – with potential costs reductions of 80-95% in total cost of monitoring.

The cons of using cloud EDC for clinical data management

Price

To start off, we are not really going to argue that there are any drawbacks to using cloud EDC for clinical trials, but there are some roadblocks to implementing it. The primary impediment to successful cloud EDC implementation is rather straightforward: price.

Paper-wise and penny-foolish

Paper systems, despite all of their issues, require a rather minimal up-front investment on behalf of the CRO or study sponsor. Paper is quite affordable. Many EDC vendors charge tens of thousands of dollars a year for their software service. It is true that some zero-cost EDC platforms exist, but they do not have the features required for many clinical trials to be successfully conducted.

Especially for some smaller Phase I studies and startup CROs, a fully featured cloud EDC system may be outside of their reach in terms of affordability. However, this should not continue to be a major issue in the near future as the industry is now bolstering with robust competition, which lowers prices. Vendors such as FlaskData.io even provide comprehensive EDC platforms at an average of 30-50% less than equivalent software.

While EDC does require an initial investment, sponsors reap enormous ROI when studies are completed with less errors and with easier communication amongst personnel. On average, a trial that implements EDC is completed 30% more quickly than a paper-based study.

Training and human interface

To round up, the other main con to EDC is plainly that some study personnel may be unfamiliar with it. That being said, the majority of clinical trial professionals now have experience with cloud EDC systems, so while unfamiliarity may be understood as possibly being a “con” to EDC adoption, it is not as frequent as it used to be. Especially that the majority of cloud EDC vendors design the software to be accessed via smartphone and tablet, there is very little learning curve involved as staff are already familiar with how to operate mobile devices. Even for those uninitiated with EDC, many vendors like FlaskData.io provide fanatical support for new users.

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