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Common data elements for clinical research in Friedreich's ataxia

  1. David R. Lynch MD, PhD1,*,
  2. Massimo Pandolfo MD2,
  3. Jorg B. Schulz MD3,
  4. Susan Perlman MD4,
  5. Martin B. Delatycki MD, PhD5,
  6. R. Mark Payne MD6,
  7. Robert Shaddy MD7,
  8. Kenneth H. Fischbeck MD8,
  9. Jennifer Farmer MS9,
  10. Paul Kantor MD10,
  11. Subha V. Raman MD11,
  12. Lisa Hunegs MSW, MPH12,
  13. Joanne Odenkirchen MPH8,
  14. Kristy Miller MPH12,
  15. Petra Kaufmann MD, MSC8

Article first published online: 12 DEC 2012

DOI: 10.1002/mds.25201

Issue

Movement Disorders

Movement Disorders

Volume 28, Issue 2, pages 190–195, February 2013

Additional Information

How to Cite

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. and Kaufmann, P. (2013), Common data elements for clinical research in Friedreich's ataxia. Mov. Disord., 28: 190–195. doi: 10.1002/mds.25201

Author Information

  1. 1

    Departments of Neurology and Pediatrics, University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  2. 2

    Université Libre de Bruxelles, Brussells, Belgium

  3. 3

    Department of Neurology and JARA Brain, University Hospital, RWTH Aachen, Germany

  4. 4

    University of California, Los Angeles, California, USA

  5. 5

    Murdoch Children's Research Institute, Melbourne, Australia

  6. 6

    Indiana University, Indianapolis, Indiana, USA

  7. 7

    Department of Pediatrics, Division of Cardiology, University of Pennsylvania, the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA

  8. 8

    National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA

  9. 9

    Friedreich's Ataxia Research Alliance, Downingtown, Pennsylvania, USA

  10. 10

    Hospital for Sick Children, Toronto, Ontario, Canada

  11. 11

    The Ohio State University, Columbus, Ohio, USA

  12. 12

    KAI Research, Inc., Rockville, Maryland, USA

*Correspondence to: David R. Lynch, Division of Neurology, Children's Hospital of Philadelphia, Abramson Research Center, Room 502, 3615 Civic Center Boulevard, CHOP, Philadelphia, PA 19104, USA; lynchd@mail.med.upenn.edu

  1. Drs. Lynch and Pandolfo contributed equally to the present work.

  2. Relevant conflicts of interest/financial disclosures: Dr. Raman receives research support that could be conflicting from from Siemens.

  3. Full financial disclosures and author roles may be found in the online version of this article.

Publication History

  1. Issue published online: 23 FEB 2013
  2. Article first published online: 12 DEC 2012
  3. Manuscript Accepted: 22 AUG 2012
  4. Manuscript Received: 14 JUN 2012

Funded by

  • National Institute of Neurological Disorders and Stroke, National Institutes of Health. Grant Number: N01-NS-7-2372

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Keywords:

  • cerebellum;
  • dorsal root ganglion;
  • mitochondrion;
  • clinical measure;
  • NINDS Common Data Elements

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. © 2012 Movement Disorder Society

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