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.
The usefulness of information obtained from a clinical trial depends on the outcome measures selected. Ideally, in pain studies, it would be of great utility to be able to directly measure the amount of painful input, and the consequent activation of associated central nervous system processes. Unfortunately, despite all the promise of technology such as functional MRI imaging, there is nothing better than walking up to a patient (or a research subject) and asking how much pain that individual is experiencing.
But it is also important to measure the effect of pain on the various facets of life, through exploring mood, enjoyment of life, the ability to function, social interactions, and sleep. Quality of life questionnaires measure the degree of physical, psychological, social and spiritual function, in addition to health-related issues—including pain. While pain does have a significant impact on quality of life, other components that determine a quality life need to be considered.
Tools to measure pain and its functional fall-out are validated and available. Groups such as CDISC are making sure researchers involved with the clinical study of pain have access to the measurements.
