The Clinical Data Interchange Standards Consortium (CDISC) is a
global, open, multidisciplinary, non-profit organization that has
established standards to support the acquisition, exchange, submission
and archive of clinical research data and metadata. The CDISC mission is
to develop and support platform-independent data standards that enable
information system interoperability to improve medical research and
related areas of healthcare.
One specific area in which CDISC is
involved centers around the wealth of information to be had through
access to the electronic health record (EHR). If research sponsors begin
to use EHRs to support data collection to streamline clinical studies,
the next step is to automate the EHR to identify a potential research
candidate, schedule that patient for the study visits and facilitate the
entry of subjects into studies. CDISC is participating with the Mayo
Clinic, Intermountain Healthcare, IBM Watson Research Labs (Watson
computers and natural language processing), and others in an attempt to
achieve the Holy Grail of interoperability in clinical research.
It is the CDISC vision to inform patient care by improving data
quality and patient safety. The goal is to accelerate the cycle through
which research informs healthcare and thus the opportunity to bring new
therapies to patients sooner.
Regarding the study of pain, CDISC
recently posted their likely Therapeutic Area Standard for pain on the
CDISC website, for public review. Hopefully, this tool will allow for
the organization of standard pain clinical trial data submitted to
regulatory bodies such as the United States Food and Drug Administration
(FDA). This is important, as one hypothesis as to the failure of so
many pain-relief medications when studied in clinical trials centers on
the inconsistent quality of the type of data collected.
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