A mounting problem in the development of new therapeutics is that, while billions of dollars are spent on clinical research, clinical trial data is frequently not shared or is not collected in a standard, sharable format. To address this practice of siloed research,” the Clinical Data Interchange Standards Consortium (CDISC) an Austin-based, global, non-profit organization has led the charge for data synchronization, developing and supporting global data standards to help improve the quality and interoperability of medical research and healthcare.

CDISC members and sponsors are volunteers who come from pharmaceutical companies, clinical research organizations, and academic institutions. They are joined together to develop and support harmonized standards for collection, exchange, submission, and archiving of data from clinical studies

In these efforts, CDISC is considered the patient’s advocate by helping to ensure that participants in clinical research trials will contribute to valuable research efforts, rather than data ending up unused in individual silos. By formatting data in a common database, CDISC has enabled sharing of data to significantly shorten the time gap between clinical research results and better clinical care decisions. In fact, using CDISC standards from the beginning of clinical research has been found to save both time and resources up to ~60% overall.

CDISC standards are considered the gold standard for medical research around the world and are widely used in more than 90 countries for study planning and data collection, tabulation, and analysis. They are required by the U.S. FDA and other regulatory agencies internationally for evaluating new treatments for various diseases and afflictions.

The CDISC Model

To date, CDISC has developed and is in the process of developing clinical data standards for 25 disease areas, including brain diseases such as Traumatic Brain Injury (TBI).

Version 1.0 of the Traumatic Brain Injury Therapeutic Area Data Standard (TAUG-TBI) was released in 2015, and is available for provisional use. The TAUG-TBI research data standards which were developed by a consortium of medical and technical experts enables the aggregation and comparison of TBI data across studies and drug programs by describing the common kinds of data needed for TBI studies, and defining concepts in a clear, unambiguous way. This will enable the harmonization of clinical data pertaining to TBI studies, streamlining research processes and improving analysis capabilities to advance treatments for TBI. These global, consensus-based CDISC standards can now support FDA submission and biomarker qualification for TBI.

Moreover, this endeavor has helped pave the way for developing related standards, such as for Post-Traumatic Stress (PTS), which was the focus of a fundraiser in March 2016 at the Texas Medical Association building in Austin, Texas.