Common data elements for clinical research in Friedreich's ataxia.

Area of Science:

• Neuroscience
• Clinical Research
• Neurological Disorders

Background:

• The National Institute of Neurological Disorders and Stroke (NINDS) initiative aims to standardize data collection in neuroscience research.
• General common data elements (CDEs) were previously developed for broad clinical study applications.
• Friedreich's ataxia (FRDA) is a complex neurological disorder affecting multiple organ systems.

Purpose of the Study:

• To develop specific common data elements (CDEs) for Friedreich's ataxia (FRDA) clinical research.
• To improve data sharing, reduce study start-up times, and aid investigators in FRDA studies.
• To establish standardized data collection methods for FRDA research.

Main Methods:

• Convened FRDA experts into a working group and subgroups focusing on ataxia, biomarkers, clinical outcomes, and demographics.
• Defined FRDA-specific CDEs through teleconferences, subgroup vetting, and public comment.
• Classified recommendations as core, supplemental, or exploratory, creating template case report forms for core elements.

Main Results:

• Developed a comprehensive set of FRDA common data elements.
• Published recommendations online in September 2011.
• Created template case report forms for core FRDA data elements.

Conclusions:

• The developed FRDA CDEs are expected to decrease clinical research initiation time.
• Standardized data elements will enhance the ability to compare and analyze data across FRDA studies.
• Ongoing assessment will determine the utility and incorporation of these CDEs in FRDA research.