Hi all.
Just a heads up, for all involved in data standardization. The
quote below comes from the 'opportunities' list generated by the
FDA under their 'Critical Path Initiative' (aimed at getting
novel therapies to patients quicker, but without increasing
risk, by addressing bottlenecks). The opportunities document is
linked from the main page for the initiative, and has lots of
other interesting stuff in it:
http://www.fda.gov/oc/initiatives/criticalpath/
One major objective might be to get this tool --
http://www.fda.gov/nctr/science/centers/toxicoinformatics/ArrayTrack/
-- to speak FuGE..? That'd then make it much simpler to
leverage some of the offspring of FuGE (MAGE2, GelML, ultimately
MS and now NMR formats) in that tool and others FDA might
develop in the future (for example, for proteomics and
metabolomics data).
Anyway, the quote:
"44. Development of Data Standards. Currently,
clinical investigators, clinical study personnel, data
managers, and FDA reviewers must cope with a
plethora of data formats and conventions. Some
clinical investigators report the presence of many
different computer systems for data entry at their
sites (for various trials), each of which uses different
data conventions. Lack of standardization is not only
inefficient, it multiplies the potential for error.
Important standards work is underway, but much
remains before the promise of shared data standards
for clinical trials is realized. CDISC is paving the
way by developing its Study Data Tabulation Model
for describing observations in drug trials [1]. That
model could someday encompass observations
needed for other types of trials. Health Level 7 and
CDISC are working to create standards that can be used for the
exchange, management, and integration
of electronic healthcare information to increase the
effectiveness and efficiency of healthcare delivery [2].
In addition to improving and expanding the Model,
sponsors and the FDA must undertake the hard work
of retooling hardware and software to apply the new
standards. This retooling includes training
researchers to collect and FDA reviewers to expect
data in these formats. Standardizing data archiving
conventions would also enable the creation of shared
data repositories, facilitating meta-analyses, data
mining, and modeling to improve clinical trial design
and analysis."
[1] For more on CDISC (the Clinical Data Interchange
Standards Consortium), see http://www.cdisc.org/.
[2] See also http://www.hl7.org/.
Sorry to those who get this several times...
Cheers, Chris.
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chr...@eb...
http://psidev.sf.net/
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