Maximizing what we learn from clinical trials: NINDS Common Data Elements

Ninds.nih.gov: 12/26/12

The NINDS mission is to reduce the burden of neurological disorders through research. Patient studies, including clinical trials that test or compare treatments, can provide important insights for understanding disease, lead to better treatments, and are essential to fulfilling our mission.  Many clinical research data sets, however, are only used to address the researchers’ original study question, in part because NINDS has left it to researchers to determine what data they would collect and how they would collect them. As a result, many different formats have been used for data collection which has made it very difficult to compare and/or combine the data sets. Creating the data sets takes significant time and resources as well as considerable effort on the part of the patients who participated in the studies. NINDS is therefore working to make sure that we learn as much as possible from them.

To ensure the best possible use of clinical data sets, NINDS has launched the “Common Data Elements” or CDE project. Central to the project is the identification of common definitions and the standardization of case report forms and other instruments.  The goal of the project is to help investigators develop and use uniform data formats so that they systematically collect and analyze data that can be shared across the research community. The CDEs are organized hierarchically and in several categories.  General CDEs (for example gender and age) should be collected in all clinical research.  The “core” CDEs are recommended for clinical research in a given disease. In addition, there are optional “supplemental” elements, or innovative “exploratory” elements.  For the last two categories, the CDEs provide a suggested format, but do not require the use of these elements.  Read more