Common data elements for clinical research in Friedreich's ataxia

David R. Lynch, Massimo Pandolfo, Jorg B. Schulz, Susan Perlman, Martin B. Delatycki, R. 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

11 Citations (Scopus)

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

Fingerprint

Friedreich Ataxia
Research
National Institute of Neurological Disorders and Stroke
Demography
Telecommunications
Information Dissemination
Ataxia
Neurosciences
Nervous System Diseases
Biomarkers
Research Personnel
Common Data Elements
Clinical Studies

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Lynch, D. R., Pandolfo, M., Schulz, J. B., Perlman, S., Delatycki, M. B., Payne, R., ... 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

Common data elements for clinical research in Friedreich's ataxia. / Lynch, David R.; Pandolfo, Massimo; Schulz, Jorg B.; Perlman, Susan; Delatycki, Martin B.; Payne, R.; Shaddy, Robert; Fischbeck, Kenneth H.; Farmer, Jennifer; Kantor, Paul; Raman, Subha V.; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra.

In: Movement Disorders, Vol. 28, No. 2, 02.2013, p. 190-195.

Research output: Contribution to journalArticle

Lynch, DR, Pandolfo, M, Schulz, JB, Perlman, S, Delatycki, MB, Payne, R, Shaddy, R, Fischbeck, KH, Farmer, J, Kantor, P, Raman, SV, Hunegs, L, Odenkirchen, J, Miller, K & Kaufmann, P 2013, 'Common data elements for clinical research in Friedreich's ataxia', Movement Disorders, vol. 28, no. 2, pp. 190-195. https://doi.org/10.1002/mds.25201
Lynch DR, Pandolfo M, Schulz JB, Perlman S, Delatycki MB, Payne R et al. Common data elements for clinical research in Friedreich's ataxia. Movement Disorders. 2013 Feb;28(2):190-195. https://doi.org/10.1002/mds.25201
Lynch, David R. ; Pandolfo, Massimo ; Schulz, Jorg B. ; Perlman, Susan ; Delatycki, Martin B. ; Payne, R. ; Shaddy, Robert ; Fischbeck, Kenneth H. ; Farmer, Jennifer ; Kantor, Paul ; Raman, Subha V. ; Hunegs, Lisa ; Odenkirchen, Joanne ; Miller, Kristy ; Kaufmann, Petra. / Common data elements for clinical research in Friedreich's ataxia. In: Movement Disorders. 2013 ; Vol. 28, No. 2. pp. 190-195.
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