A few days ago I was alerted to a discussion thread on LinkedIn by a good friend. I started reading and became increasingly alarmed by what I found. The thread can be found here. Please read the thread.
My concern is based around a commercial organization taking out a patent on work that I consider to be already in the public domain. What is worse is that I, and many others, worked hard to not only produce the idea but also ensure that the work was placed into the public domain with no restrictions on who could use it.
My story begins in 2000 and before working with eDiaries within clinical trials. When working with customers, about the fourth question they asked was, – this is after the “is it part 11 compliant” question – “Where is the source data?” At that time, I did not have an answer but it interested me. So, when in 2002, I had some time, I started reading everything I could find on the regulations about source data. I remember reading papers by Paul Bleicher, then at Phase Forward, and by Steve Raymond of PHT fame and discussing the issues with these learned folks at DIA meetings. In 2003, I wrote a paper for the peer-reviewed, Applied Clinical Trials. In order to get that article past peer-review, I remember having to remove a suggestion that the basis of an eSource Data Store should be the CDISC Operational Data Model (ODM). Apparently, the suggestion of using standards at that time was considered too controversial! The article was published in February of 2004.
By this time, I was working with CDISC furthering the cause of the ODM with the FDA. I have just looked back at presentations that I gave with Dr Rebecca Kush at the FDA in late 2004, extolling the virtues of the ODM and starting to discuss eSource. In late 2004 the FDA invited CDISC to look at the question of eSource and the existing regulations. I was fortunate enough to co-lead the team and, in November of 2006, the final version (after six drafts, four of which went out for public review) of the eSDI paper was published.
While working on the eSDI paper, CDISC were attacked for having the audacity to tackle the subject and there were those on the CDISC Board who questioned whether CDISC should be dealing with such a topic. But in the end the work was well worth it because that document lays the foundation for the use of eSource within clinical trials, irrespective of technology. By developing the 12 principles that are described within the document, any solution can be assessed and seen to meet the regulatory need or not. The paper also presented five potential architectures.
Then came something that I am proud of. The EMA decided to base their eSource guidance on the eSDI work and by doing so, I believe, improved on the eSDI content. The FDA also updated the Computerized Systems Used in Clinical Trials (CSUCT) document to become the CSUCI guidance document and put a toe into the eSource waters. Unfortunately the FDA then released a draft eSource guidance and failed to follow the EMA’s lead by utilizing the CDISC paper.
In parallel with all of this, I was working with Landen Bain as he led the charge to look at practical – and I stress the practical – ways to integrate Electronic Health Records with Clinical Research. Through Integrating the Healthcare Enterprise (IHE), he led the work on the RFD profile that came to fruition in 2007, with several demonstrations of capability at the HIMSS conference in New Orleans. Included in that demonstration was the first incarnation of an eSource Archive based upon the CDISC ODM. This demonstration turned into a formally developed system that has been used in subsequent IHE connectathons and HIMSS events both in the US and Europe. It has been used in several demonstrations of eSource capability to the FDA and has been demonstrated at the 2011 DIA Annual conference. That eSource tool contains the ability to use ODM as an eSource Document, read them, it has audit trails, user roles and leverages the ODM’s metadata to provide meaningful displays of the data and audit trail.
The picture I am painting is one of several threads of activity, all undertaken within open standards development organizations since 2004, with many volunteers and organizations giving their time feely and working in a spirit of cooperation to develop solutions that are for the benefit not only for those giving their time but also for the benefit of clinical research organizations (in the most generic sense), regulatory agencies and ultimately the public with the provision of better and safer products.
I looked back through many presentations that I have given on eSource. Within these presentations are ideas for system topologies, descriptions of the issues and many suggestions. Audiences include the FDA, EMA GCP inspectors and DIA meetings in both the US and Europe.
I am deeply saddened by the discussion in the thread. Having put in many hours working with many others who have also made significant contributions to bring clarity to a difficult subject for the benefit of all, it is galling to consider that an organization can patent ideas where there appears to be a huge overlap with the work done by CDISC and IHE. I have yet to see anything within this patent – I am happy to be proved wrong – that is not covered by the work undertaken by many volunteers since the first steps back in 2004.
Here are just a few of the presentations across the year’s to give a flavour
DIA Euro Meeting, Lisbon, March 2005
Slides 37 through to 43 inclusive discuss the Trusted Third Party
EMEA, London, June 2006
Slides 49 & 50 are interesting. They present the generic eSource archive/store architecture.
DIA CDM Meeting, Florida, March 2007
Slides 22 to 25 show the relationship between the IHE RFD profile, eSource and a Trusted Third Party (the Archiver)