Has EDC jumped the shark?
Electronic data capture (EDC) has brought 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?
Clarification added March 14, 2008:
A Note on Confidentiality:
This is the first time that I've used LinkedIn for this purpose. I neglected to state that I would treat all responses, both public and private, as confidential. I will not quote, repeat or otherwise attribute the content of any answer in conversation or in any of my published research. This Q&A is for our mutual edification.
Good Answers (6)
Current vendors are promising too much for the fees they are charging. I believe very strongly that EDC [and all it's complimentary solutions] can become the transactional systems to transform how trials are conducted IF sponsors and others who conduct research are open to change and viewing their world differently.
Just as ERP have transformed business [just in time inventory, integrated ordering/sales systems] and EHRs are changing how medicine is delivered [still a work in progress] EDC has the potential and the technology is readily available.
I just hope we can accelerate the change management. IMHO EHR adoption is being held back by legacy thinking and failure to manage behavior change. We in the vendor community need to do a better job of communicating and delivering value to users and customers IF EDC has a shot at transforming clinical research. Value is defined differently, but we need to make it easier for folks to purchase, deploy and use our [collective] software.
This space is ripe for disruption and the forces of the market will begin baring down on the incumbents. there are small, innovative companies out there that will bring better software and a cheaper price to the market, and only those whose business/cost model can adapt will survive.
Every software market has evolved this way and EDC is no different. We have the potential to change and optimize research BUT only if we deliver on our promises and it's going to take industry leaders, along with second and third generation software vendors to push the industry forward.
Joe K
Candidate: US Senate | VP of Architecture & UX F250 Financial | Founder of: Charity, IT Consulting & Bath Products Cpny
Best Answers in: Business Development (1), Computers and Software (1), Web Development (1)
Only an opinion: In general the clinical space (or a part of it) is still trying to deal with compliance issues of recent legislation. It seems that the medical industry and other industries are battling on 2 fronts - how to implement instantaneous data capture - work flow and storage which would really revolutionize the industry, while at the same time trying to implement some very very basic needs around compliance (HIPAA).
There is no doubt that if planned and implemented from a clean slate EDC feeding in real time transactional data is possible. But that is not the space we live in. Any legacy facility with legacy systems has to worry about integration, process and reporting and the solutions can't do it all - namely they can't integrate instantaneously - there is a delay.
Opinion: EDC is an evolution toward real time data acquisition, but if you can't address the core problems that are still occurring in the industry around basic documentation compliance, you can't move immediately to real time acquisition.
I don't think the majority of the industry is ready...I can sell you a hydrogen car today but if you cant fill it up... why buy it. I am all for trying to speed up technology, but when you try to sprint from a slow walk sometimes you trip... or slow yourself down more.
Links:
Joe K also suggests this expert on this topic:
I don’t believe it has jumped the shark. I do believe that eClinical solutions have yet to fulfill all that has been promised. EDC in a hybridized solution set (electronic, paper, fax) combined with CTMS, IVRS and adaptive trial design will in the future provide the increases in operating efficiency, cost reductions, and enhanced clinical quality that has been promised. Companies like ClinPhone and MediData have the best chance of meeting this challenge in the near term.
Chris, the following is my blog entry on your question (minus the html links). The original can be found at www.tjkuhn.com:
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.
(Chris' Question)
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
Links:
I believe the issue is integration between EDC and CTMS, plus how well clinical operation is supported by corporate IT.
Chris,
To answer your questions :
Yes - EDC vendors are perceived to be promising too much since this is a technology / process in transition which needs equal contribution from all involved - product owners, investigating sites, sponsors etc., to make it successful in delivering its end result.
No - since EDC is a technology driven workflow / data processing and validating system - again, in its present form, which cannot enable real time adaptive trial design in the transaction mode.
Yes - EDC is an interim technology in its present state and it is exiting and interesting to see how it will progress in the near future !
More Answers (1)
Sean P
Scientist and Biotech Entrepreneur
Best Answers in: Biotech (3), Compensation and Benefits (1), Product Design (1), Starting Up (1)
Hi Chris:
You may be interested in the following conference
IBC’s Adaptive Designs for Clinical Trials conference,
to be held April 21-22 in Boston, MA
http://www.ibclifesciences.com/adaptive/9197.xml
