Recommendations for myasthenia gravis clinical trials

Michael Benatar, Donald B. Sanders, Ted M. Burns, Gary R. Cutter, Jeffrey T. Guptill, Fulvio Baggi, Henry J. Kaminski, Renato Mantegazza, Matthew N. Meriggioli, Joanne Quan, Gil I. Wolfe, Richard J. Barohn, Ted M. Burns, Gary R. Cutter, Jeffrey T. Guptill, James F. Howard, Henry J. Kaminski, Renato Mantegazza, Matthew N. Merrigioli, Steven PiantadosiAlexis Smirnow, Gil I. Wolfe

Research output: Contribution to journalArticle

81 Scopus citations

Abstract

The recommendations for clinical research standards published in 2000 by a task force of the Medical Scientific Advisory Board (MSAB) of the Myasthenia Gravis Foundation of America (MGFA) were largely successful in introducing greater uniformity in the recording and reporting of MG clinical trials. Recognizing that changes in clinical trial design and implementation may increase the likelihood that new therapies are developed for MG, the MGFA MSAB Task Force here presents updated recommendations for the design and implementation of clinical trials in MG, including (a) the use of a quantitative measure, such as the MG-Composite, that is weighted for clinical significance and incorporates patient reported outcomes; (b) consideration of nontrial strategies; and (c) development of biomarkers that support mechanistic studies of pharmacotherapies. The hope is that these updated task force recommendations will expedite the development and acceptance of more effective and less noxious therapies for MG.

Original languageEnglish (US)
Pages (from-to)909-917
Number of pages9
JournalMuscle and Nerve
Volume45
Issue number6
DOIs
StatePublished - Jun 2012

Keywords

  • All clinical trials
  • Clinical trials methodology/study design
  • Myasthenia
  • Outcome measures
  • Quality of life

ASJC Scopus subject areas

  • Clinical Neurology
  • Cellular and Molecular Neuroscience
  • Physiology (medical)
  • Physiology

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