Blogs & eSource: some ponderings

Over the last few months, Dave and I have been working hard and as a consequence our blogging has not been as prolific as it has been in past months. However, like all good ‘bloggers’ we continue to read the blogs of others with fervour. So I have been intrigued by a few posts in recent weeks that I thought I would draw your attention to, either because like me you are interested in the power of social media or because as the biopharmaceutical industry moves forward, social media goes with it.

First of all I thought I’d draw your attention to John Halamka’s blog. It’s an interesting mix of highly technical records of the current developments in the HIT world (which at times seems mind boggling!) and government policy, along with some new and interesting technology observations and some very personal revelations about his family. I don’t think I have ever read anything controversial or even remotely tricky in his Blogs (which in my opinion is not the purpose of a Blog, it should always raise questions and invite comments), however to read that he has had his Blog used against him was rather surprising. Blogs and other forms of social media are public documents that are there to engage an audience; they are snapshots of thoughts and ideas that help to create a better understanding of our industry. I think we need to be careful about what we say but not so careful that freedom of expression and good debate are squandered for dry renditions of current developments that don’t interest anyone! Most criticism seems to come from those who either don’t write blogs themselves or can’t imagine how anyone who is doing any work has time for such linguistic efforts.

So moving on, CDISC have been producing some interesting Blogs about the Interoperability Showcase at the recent DIA Annual meeting in Chicago (There’s a good webinar about it here). For Dave and I, this has a personal interest as we are an integral part of the Archiving solution for the Retrieve Form for Data (RFD) capture profile (developed by IHE) along with our partners IPL. From the first moment Dave and I started working together, he had a deep conviction about the way that an electronic archiver could solve many of the ‘paper’ based challenges for research and also that having an archiver meant that health records did not have to be 21 CFR Part 11 compliant (This is a fairly weighty but important tome which you can find here). Dave and Dr Kush (CEO CDISC) worked together on the highly influential eSDI document that has been referenced by EMA and I was extremely privileged to be at White Oak when they met with the FDA to give some clarity around the 12 scenarios. You can find out more about the archiver by contacting us and of course we are more than happy to explain how important it is to the success of RFD. One of the key benefits of the archiver however is the notion of traceability. When the regulator asks to see the source of your data 7 years after you started your study, can you find it easily? Is the physician’s office where you conducted the original research still there? Is the CD of the paper report forms still in existence and does it still work? What if you are looking for data to look for new indications for a therapy? Can you quickly retrieve all the original data? If you don’t have a central source, this can be tricky at best, time consuming at worst or perhaps a complete disaster if you can’t find the data at all. Another important consideration is that while there are disparate electronic health records and systems that have been implemented globally, the RFD solution is the best possible way to capture research data in order to develop that truly electronic trial. This is something Assero is passionate about (in fact Dave has written about it here in a recent blog and our main page on Standards for eClinical also outlines what we do). It was a shame that Dave and I were simply too busy to attend the Showcase and the Annual but I am hoping a certain Landen Bain will be bringing his great carnival to Europe next year, as after all we have electronic health records here too and it would be interesting to get a discussion going this side of the pond!

Finally, I know that the on-going debate about social media for research has moved on from when I wrote one of my previous blogs, there has been news about Pfizer using social media (or an interactive method for collecting data)  and there is a good blog here about the relationships involved and participation in trials where you don’t necessarily talk to a  physician. It makes for an interesting read and, as I suspect the industry seeks better data and compliance by patients, new methodologies will be sought to capture data of that I am sure. So watch this space as the debate rumbles on and don’t be shy, let us know your thoughts.

 

4 comments on “Blogs & eSource: some ponderings

  1. Yes, the DIA Showcase was a hoot, and yes we hope to bring the same concept to the DIA meeting in Copenhagen. Thanks for the mention, and for the links to the blogs at CDISC.org.

    There is one anecdote from the Showcase that sums up the value of the RFD approach. One
    EDC company who participated in the demonstrations for the first time did not find the right technical resource to prepare for their part until June 3, and the Showcase was slated for June 20. And they made it. In a mere three weeks, one technician wrote the Form Manager and Form Receiver actors, and developed the transactions that accepted and applied EMR pre-pop data, surfaced the form in the EHR, and send data to the archiver. The technician did an extraordinary job, and deserves credit. But this short term accomplishment is also a credit to RFD, which has a simplicity and elegance that allows for simple adoption. In fact, I believe that RFD is poised to go viral, which nothing complicated ever does, as Doug Fridsma said, after seeing the demo in Chicago.

    If you are interested in more, Wayne Kubick’s blog at http://blog.appliedclinicaltrialsonline.com/ might just be the best last word.

    1. Thanks for the feedback Landen, that’s great news that the Showcase is making its way to Europe! As you know, I am a keen advocate of any methodology or concept that keeps things clear and simple. Implementation of standards is only going to work if solutions like RFD are forthcoming, as in my newly forming experience the barriers to adoption are considerable. Thanks for the link to Wayne’s blog too, well worth a read!
      AJ

  2. I fully agree with Landen about the credit to RFD.

    I recently took part in the SMArt Challenge “SMArt Apps for Health” (http://challenge.gov/challenges/134) where an EHR system was made available with the challenge of “doing something useful with the EHRs”.

    I essentially used the RFD and CRD profiles to generate an “App” for prepopulating CDASH DM and CM forms in a mock EDC system.

    Creating the “App” and getting it up and running just took me three weeks, the amount of work involved was about 1 man-week. I must admit that I had the advantage having already some things in place, like the XForms web application, and the CDASH forms in ODM and XForms format. Also an archiver application using transformation to ODM and to PDF was already in place.

    I didn’t win first price, but got an “honorable mention”.

    The RFD and CRD profiles gave me exactly the framework I needed to get this done so quickly.

    1. Thanks Jozef!

      I like the idea of Apps and I think your approach is fantastic. I am seeing wider adoption of the App approach in the healthcare world (there seems to be increasing use of iPads and Android equivalents).

      I am keen to see Landen’s RPE come to life too … that would make the front end process really open up to a fully electronic clinical trial.

      Great discussion,

      AJ

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