Why Pharma Needs an EHR to EDC Connection
by Hugh Levaux, on Jun 19, 2018 10:00:00 AM
I know for many readers this is a rhetorical question but asking the question helps us to understand better the solution and what is at stake here. So the big question is why do Sponsors need an EHR to EDC connection? There is an easy answer, it makes for better data, but there are several facets to this answer.
Manual data entry and manual verification of data entered into EDC, is 100% manual and can be one of the most problematic issues in clinical trials. The problems revolve around correct identification of source (correct subject, correct visit, correct data) and data transcription. Problems surrounding identification of source are known problems at the clinical site but are rarely understood let alone quantified by the Pharma Sponsor. We will discuss this issue in a subsequent blog. Classically, transcription has been the only reliable, brute force method to get data into your EDC - it works across all source data modalities. Transcription works, but there are significant limitations, namely the human element.
The reason why we have transcription brings us back to the Faustian Bargain at the beginning of the EDC industry. EDC was, and still is the grand attempt to digitize the subject data that becomes the clinical data reported to the FDA, getting rid of paper in the process. The bargain at the time, around 1998-2003, was that electronic hospital systems were not generally available just yet, and other technologies were not quite ready. But the ability to collect clinical data over the internet was ready, and the industry needed a way to get all that valuable patient data into these exciting new web-enabled EDC databases.
With only EDC as a proper technology available, an entire new workstream developed around the manual transcription of source data into EDC -- a web-enabled paper process. This is the “swivel chair" between source data and EDC data entry.
This process created new problems for data management. Gone was double data entry. Now data management had to figure out how to “guide” data entry with a large array of edit checks. Edit checks notwithstanding, source data validation (SDV) remains necessary. In other words, while EDC was successful at displacing paper, manual transcription created its own set of challenges, without removing the need for SDV.
So the idea of getting rid of the human element in the transcription process remains the key to unlocking productivity and data quality. .
Fortunately, while the Pharma industry was investing in deploying EDC, the healthcare industry invested heavily in their own Health Electronic Record (EHR) systems. Nowadays, sophisticated EHR systems relying on common data standards and interfaces are now available to make the EHR-to-EDC data transfer a reality. Such transfer eliminates the need for transcription and associated SDV. In short, the original promise of EDC gets realized: better data management that transcends data entry errors and focuses on clinical issues with the data. To be clear, we are talking about Clinical Pipe and its ability to insert data straight from EHRs directly into existing EDCs, like Rave. All the site coordinator needs to do is to correctly match the data between the EHR and the EDC timepoints. With a simple click of a button the data gets inserted in the EDC database, the Sponsor’s system of record. Here are the key benefits of a connection between EHR and EDC.
100% Consistent Data
At the heart of why we need the EHR to EDC connection is to get 100% accurate data. When data is simply copied from EHRs to EDCs via APIs, then there is no transcription. There is no need for SDV as the data in EDC is identical to the source, simply because it came directly from the EHR, no human intervention. If the data is wrong, then it’s wrong in the EHR and that is a different issue that requires data changes in both systems. So as you can see, by simply getting rid of transcription we have made our data in the EDC that much better, and with better data, you get less SDV, less data review, and less monitoring. Imagine that!
Time and Timelines
And so when your data is pulled directly from the EHR, your data is now much cleaner, and of course, clean data needs less review and validation. When that happens, you start to spend less time in mind-numbing SDV review and can focus on higher-level clinical review. And of course when you know your data is clean and correct sitting in your EDC, well then you start hitting your timelines more often, with less stress. Imagine being able to cut your timeline! Imagine sitting at the meeting and knowing Data Management has gotten the job done on time, all the time.
Well, now we know you have got your clean data, on time, with less stress, and now you get the benefit of Reduced Cost. It is not hard to imagine that when you get rid of the overhead of transcription, you will inevitability save money. (In a future blog post we will explore those numbers in much more detail but rest assured the saving are amazing.) Think about what you buy when you buy transcription, an army of highly trained and educated clinicians dispersed at sites across the world doing simple data entry. What a waste!
This might be news to you, but I am going to let you on a little secret, what the sites hate is doing transcription. That's right I know it’s shocking, but the reality is that transcription is driving them crazy. The pain gets even more acute when they need to respond to countless queries that only reminds them of how painful data entry is. And with the increasing complexity of clinical trials, EDC is last on the todo list. With the EHR to EDC connection, they don't have to dread the work. On a product like Clinical Pipe, it's as easy as clicking a button within the EHR to transfer. And then the prospect of less SDV, less review, less Sponsor, or gulp CRO over their shoulder making sure they got every 1, 0 and decimal point correct. You get to make the job better, sure there is a new process, but it's a new process that will add up to more free time for them and less stress. Offering Clinical Pipe will make you the site's ”Sponsor of choice”.
As you can see, Pharma needs the ability to quickly and easily integrate EHR to EDC. The process of transcription is a process of the past that costs stress, time and money on the industry. The time has come for innovation and technology to be able to overcome this legacy of the past. That is what Clinical Pipe is all about. Our mission is to leverage innovation and technology to make the job of Sites and Sponsors better and easier. Most of all we want to make sure Data Management is getting the right data, the first time and every time.
We are here to help and so Please contact us to continue the conversation or to learn how we can quickly get the process started so you can get your site’s EHR connected to you existing EDC system.