22 April 2012

CDISC: Setting Standards for the Study of Pain

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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