Common data elements for clinical research in Friedreich's ataxia

David R. Lynch, Massimo Pandolfo, Jorg B. Schulz, Susan Perlman, Martin B. Delatycki, R. Mark Payne, Robert Shaddy, Kenneth H. Fischbeck, Jennifer Farmer, Paul Kantor, Subha V. Raman, Lisa Hunegs, Joanne Odenkirchen, Kristy Miller, Petra Kaufmann

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.

Original languageEnglish (US)
Pages (from-to)190-195
Number of pages6
JournalMovement Disorders
Volume28
Issue number2
DOIs
StatePublished - Feb 2013

Keywords

  • Cerebellum
  • Clinical measure
  • Dorsal root ganglion
  • Mitochondrion
  • NINDS Common Data Elements

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Fingerprint Dive into the research topics of 'Common data elements for clinical research in Friedreich's ataxia'. Together they form a unique fingerprint.

  • Cite this

    Lynch, D. R., Pandolfo, M., Schulz, J. B., Perlman, S., Delatycki, M. B., Payne, R. M., Shaddy, R., Fischbeck, K. H., Farmer, J., Kantor, P., Raman, S. V., Hunegs, L., Odenkirchen, J., Miller, K., & Kaufmann, P. (2013). Common data elements for clinical research in Friedreich's ataxia. Movement Disorders, 28(2), 190-195. https://doi.org/10.1002/mds.25201