Upcoming DSE TC topics

Thanks Kerstin,

I agree with your comments... Is there a reference for the current ~20 domains already supported? Would be good to know them in more detail... I'd like to capture all the necessary resources and link them on the wiki site.

We also need to come up with 2 or 3 examples of what "recombinant clinical data" looks like and can uniquely do. This will be very important defining our role within the larger CD community. 

Based on you note, another question to consider is "Where specifically does the tabulation model fall short when trying to address biomarkers?" I can imagine several potential places, but we should identify these as a group. For example, do we use something like a "classification structure" that (1) maps a qualified set of measured (probe base) molecular analytes to a subject in a study, as well as (2) maps them to the gene or metabolite references behind each analyte ((3)plus a pathway), and (4) bundle the analyte group with a statement to what disease or condition (e.g., hepatotoxicity, inflammatory response) they should be applied to. A comparison of the current domain-observation model to the proposed "classification" model seems to be in important next step!

BTW, "Biomarkers" should always be "measureable factors" that, in addition, are usually "biochemical features or facets", but could also be "enhanced images of cells or tissues" or even other forms of per subject measurables, such as EEGs. Clearly there should be an easy and direct way to determine of the biomarkers are of type "biochemical feature", and here is where I see RDF helping us out tremendously!

best,
Eric

On Oct 29, 2006, at 2:47 PM, Kerstin.L.Forsberg@astrazeneca.com wrote:


	Hi Eric,
	hope we manage to find a new asap for a TC, see another email regarding
	avalibility.

	Here some other comments:

	- Glad to see that you have met Wayne Kubick, the CDISC/SDS (SDTM) team
	leader. 

	- You also mentioned BRIDG: Yes, I think we should discuss potential links
	to the HL7 BRIDG work. (A very good overview of BRIDG as a webcast can be
	found at bettermanagement.com,
	http://www.bettermanagement.com/seminars/seminar.aspx?l=13763). My
	spontaneous comments on it is that the intention of BRIDG is very good: "To
	define implementation-independent domain semantics, To uncover the myriad of
	semantic ambiguities present in the complex domain of clinical research".
	However, I think they may have got lost in trying to do backward UML
	modelling starting from existing data exchange standards.


	- I also wanted to highlight something I read in the last TC in the overall
	HCLS group http://www.w3.org/2006/10/12-HCLS-minutes.html: > CDISC have no
	support for biomarkers

	I don't think that is a correct statement:

	CDISC provides "... a general framework for describing the
	organization of information collected during human and animal studies. The
	model is built around the concept of observations, which consist of discrete
	pieces of information collected during a study."  So far, the model has been
	applied for 20+ different so called domains of observations like Vital
	Signs, Microbiology, Pharmacokinetic, and more to come. However, with the
	fundamental model SDTM provide of qualified and identified observations any
	type of observations on subjects can be specified even though CDISC has not
	yet provided a data exchange domain for it.

	However, so far CDISC have only considered implementations for
	tabulated datasets for exchange per clinical study (as SAS format, and later
	on in XML using CDISC's general messaging format).

	In the Drug Safety and Efficacy task force we will put a semantic
	web perspective on the model and propose an open ended RDF implementation to
	ensure that observations become recombinant cross clinical studies applying
	ontologies for different types of observations.

	When I read definitions of the broad term "biomarkers" such as this one:
	"A biomarker is some measurable factor that is specifically
	associated with a particular medical condition." or "A biochemical feature
	or facet that can be used to measure the progress of disease or the effects
	of treatment."

	I do interpret "measurable factor" and "biochemical feature or facet" as
	"observations". Would be interesting to hear your point of view. 


	Hope to talk to you soon
	Kerstin


	-----Original Message-----
	From: public-hcls-dse-request@w3.org
	[mailto:public-hcls-dse-request@w3.org]On Behalf Of Eric Neumann
	Sent: 26 oktober 2006 23:50
	To: Kerstin.L.Forsberg@astrazeneca.com; Bo.H.Andersson@astrazeneca.com;
	James McGurk; Ted Slater; Uwe Trinks
	Cc: public-hcls-dse@w3.org
	Subject: Tomorrow's DSE TC



	Folks,

	We are still on for tomorrow's 9-10am EDT call, though Kerstin has informed
	my she can not make it. If enough need to excuse themselves we could
	reschedule, but I would suggest we try and move things forwards with this
	next call. BTW, Has everyone subscribed to the new list:
	public-hcls-dse@w3.org ?

	I also met briefly with Wayne Kubick today (Lincoln Tech is part of
	Phase-Forward now), and gave him an overview of what we've discussed and
	plan to do. He has offered to  get us more closely connected with the BRIDG
	project (SW and model alignment), so we should also discuss this option.

	Proposed Agenda:  Discussion around SDTM Model, it's current functional
	specs,  and it's limitations...

	 - please see
	http://esw.w3.org/topic/HCLSIG/Drug_Safety_and_Efficacy?action=AttachFile&do
	=get&target=CRT_DDSpecification1_0_0.pdf,

	http://esw.w3.org/topic/HCLSIG/Drug_Safety_and_Efficacy?action=AttachFile&do
	=get&target=CDISC+SDTM+overview.doc, and
	http://esw.w3.org/topic/HCLSIG/Drug_Safety_and_Efficacy?action=AttachFile&do
	=get&target=CDISCs+SDTM+basics.ppt

	cheers,
	Eric









Eric Neumann, PhD
co-chair, W3C Healthcare and Life Sciences,
and Senior Director Product Strategy
Teranode Corporation
411 1st Avenue South, Suite 700
Seattle, WA 98104
+1 (781)856-9132
www.teranode.com

Received on Tuesday, 31 October 2006 16:03:05 UTC