RE: CDISC models clarification and context of use case for EHR - Clinical Research Interoperability



Thanks for the well thought out e-mail. Would like to share a few thoughts...


I am trying to determine the over-arching use-case context for this Clinical
Observations Interoperability demo, in order to determine the appropriate CDISC
model for this pilot project. I think a broad context (e.g., EHR --> screening
for trial eligibility, or EHR --> Phase1 trial adverse events) needs to be
defined here first; and then specific examples, such as the breast cancer
domain, and a project strategy (OWL, RDF, etc) can easily be generated.
However, I am having considerable difficulty in identifying a context and
justification for the use case and wanted to solicit feedback from the group
before our next call on 8/28.

[VK] Absolutely agree with you on this one.


I had originally thought that a clear and easy context, one that would be
relevant both to investigator-initiated and industry-sponsored studies, would be
the use of EHR data to estimate study population sizes or to identify persons to
participate in trials. But, this would not be a "regulated" use of the clinical
data, so I do not even see CDISC standards (at least current ones) logically
fitting into that scenario.

[VK] Would like to propose that we approach this iteratively. For instance,
let's first develop the use case without worrying about the CDISC models to
start with

As we proceed on our design and analysis avtivity a potential outcome could be
(a) The gaps in the CDISC standards; and/or 9b) supplementation of these gaps
using appropriate clinical models such as DCM, for e.g,.


So maybe one could try to flesh out Stan's use case idea posted on the wiki.


The CDISC Study Data Tabulation Model (SDTM) is the standard for the regulatory
*submission* of clinical trials data (implying that the trial has already been
conducted). The SDTM standard is designed only for the regulatory submission,
and is not necessarily an operational standard.  I assume individual
pharmaceutical companies store their data in a variety of different models (for
which none are "standard") and then they convert the data into SDTM before
submission. So, if the group wants to use SDTM as part of this demo, a use case
based upon sharing EHR data for a phase 1 or 2 trial would seem more

[VK] One of the key goals of Semantic Web standards is to reuse data and
metadata for different purposes. For instance, it would be perfectly fine to
re-use the SDTM data elements, that have been created for submission

of data in the context of patient recruitment/EHR, etc. Of course, there will be
gaps, etc. identification and address of which could be one of the outcomes of
this work.


However, I am not convinced that EHR data is collected in a structured fashion
or at time points that would make it useful in that scenario (e.g., Do all study
visits necessarily collide with a clinical visit? If so, does the clinician need
a formal association with study or training in order to collect the data with
rigor required by the research protocol?)  

[VK] I think the key issue is to investigate whether some of the data collected
in a clinical encounter can be re-used in the context of a clinical study,  Can
you elaborate what the impact of a stuffy colliding with a clinical visit be? 


"Data collection with the rigor required in a research protocol" is an
interesting point and wondering if one could bring out some of these
requirements in the use case we develop. We can then try to see the

extent to which these requirements can be captured in the information models and
mappings, and the extent to which they can be automated by other means.


CDASH is still early in development and focused on determining a set of
(minimum) required elements for data collection (forms) in certain areas, such
as adverse events, medical history, demographics, etc. There is significant
potential for overlap in scope/activity of CDASH with the SDTM activities, and
the CDISC organization has just recently developed processes to make sure that
the terminology suggested by CDASH does not conflict with what are becoming
close-to-final standards for SDTM terminology.  Since CDASH is really a data
capture standard, it seems to be more appropriate to use as a target model in
this project, but it is really quite new and I am not sure when it will become a
finalized CDISC standard.

[VK] I don't think we need to worry about whether a CDISC standard is finalized
at this time. In fact, if we demonstrate a convincing use case, then we can
probably ask them to include it in the standard or something?


We could assume that SDTM represents (or will represent) a (FDA) standardized
data structure, terminology, and code sets, and that CDASH will be harmonized
with it some day (soon I hope). In that sense we could justify its use, but it
would be nice to find some business justification for EHR-Clinical Trials
interoperability that could be appreciated by a wide audience.  [[What about
post-market surveillance for AEs? Or populating the EHR with clinical trial
data? Or retrospective studies that abstract data from EHR, but these are not
typically FDA-regulated, are they?]]

[VK] I think that could be a valid assumption in this context. And to keep
things simple, one could focus on the information flow from the EHR ==> Pharma
and not the other way around. Would propose that we

focus for now on Eligibility criteria...


What is very clear to me, as most of you know and we discussed on the phone last
week, is that Lainden Baines and others from CDISC should be very involved in
identifying the use case, and certainly he will be able to correct any of my
mis-understandings of the CDISC standards. Either Vipul or I hope to be in
contact with him next week. I hope that those in the group with understanding of
regulated research environment or CDISC standards will join in this thread as

[VK] Landen Bain from CDISC will be presenting on the August 28th call focusing
on the aspects that are relevant our activity..


Once a context is fleshed out, then I think it will be quite easy for me to find
examples of protocols that require certain information types (e.g., lab,
diagnosis, imaging, genetic) that we would like to demonstrate interoperability
between the EHR (via Stan Huff's Clinical Data Model structure) and the
appropriate CDISC model. 

The use-case and context are critical to the success of the project. I hope that
those of you on this list serve with relationships/experience with
pharmaceutical industry can help focus me on this, because I am struggling with
it. Meanwhile, I am still thinking hard on this....  Have a great weekend.

[VK] Yes. Would propose that you come up with a first draft of the use case
without unduly being worried about the various standards, etc. We can work that
out in our analysis and design.





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Received on Wednesday, 22 August 2007 03:22:07 UTC