T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

The difference between eDC and eCRF

Posted by tjkuhn on March 14, 2008

I got this LinkedIn question from Chris Connor (Health Industry Insights) about the future of eDC and whether it has “Jumped the Shark”….whether it has peaked.

Has EDC jumped the shark?

A phrase once used exclusively within the entertainment industry, “jumping the shark” has recently entered the public vernacular as a way to mark the point at which something passes the zenith in its popularity.
Electronic data capture (EDC) has ushered in many changes to clinical development. And in many ways, it is transforming the way clinical trials are conducted. But are EDC vendors promising too much? Can EDC become the real-time, transactional system that enables adaptive trial design? Or is EDC an interim technology?
If you have an opinion, I’d love to hear it.
~Chris

His question is a good one that is on the minds of many in the industry (Pharma), including mine. I’ve been meaning to resume my posting here since my move, and this seemed to be a good topic with which to start.

I met Chris at the last ExL Pharma meeting on eHR’s (Electronic Health Records) and eDC (electronic Data Capture). Chris works for what I’d term a Healthcare/Pharma/Technology Think Tank (a HPT3). Well, we got into a discussion at the conference and continued it over dinner. Our backgrounds are pretty different, and yet we still felt the same passion about this geeky medical/science/ethics/technology stuff. It was a really good exchange of ideas.

I have been thinking about eDC a lot of late, mostly because what is commonly called eDC is not eDC. I asked the guy who was at the same ExL Pharma conference presenting for Oracle about whether he was talking about “True eDC”. He was confused and asked for clarification on what I meant. I explained what I meant…My colleagues, both past and present, have heard this before….

What many people are calling eDC is actually eCRF (electonic Case Report Form). A CRF is the standardized form on which the Clinical site (Lay People can think doctor’s office) transcribes relevant data from the medical chart (also called the source) of a clinical trial subject. This form is sent to the sponsor (typically a pharmaceutical company) who enters this data into a computer system and analyzes it to see if their treatment is safe and effective. An eCRF is an electronic form that does the same thing. The clinical site types the data into an electronic form that gets electronically submitted to the sponsor. Essentially, the sponsor is removing a (paper based) step and pushing the data entry from their internal (Data Management) group to the clinical site. That’s eCRF.

Now “True eDC” deals with data being recorded as source in an electronic format. That means that it isn’t written in a paper medical chart. The first time it is recorded (in any manner) it is recorded electronically. For example, an electronic blood pressure (BP) cuff that automatically transmits the BP to a computer system OR a physical exam that is directly typed into a computer system (not written first). eDC can entail structured data fields, free-text entries, or combination of both.

Although the terms eDC and eCRF are used pretty much interchangeably in the clinical/GCP arena (with most using the eDC term, there are very few implementations of “True eDC” (mostly in Self-contained Phase I units). To Chris’ primary question about whether eDC has peaked, I say “No, we haven’t even begun to scratch the surface of what is possible yet”. There’s a long way to go and the benefits of going there will be tremendous….It is also likely that the costs for early adopters will be quite tremendous as well.

Big Pharma is a pretty conservative beast…they will likely be slow to adopt. Over the longterm, this turns the industry on its head. The small Biopharma that traditionally followed what Big Pharma did will now be the leader…and Big Pharma will follow (or slowly become irrelevant). Chris asked if eDC was an “interim technology”. I say all things are transient and all technologies are “interim”. The next ten years will be a very interesting period in the Healthcare/Pharma fields, and I for one will be interested to see where it all goes.

~TJK

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