Recommendations for myasthenia gravis clinical trials.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Benatar, M; Sanders, DB; Burns, TM; Cutter, GR; Guptill, JT; Baggi, F; Kaminski, HJ; Mantegazza, R; Meriggioli, MN; Quan, J; Wolfe, GI; Task Force on MG Study Design of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America,

Published Date

  • June 2012

Published In

Volume / Issue

  • 45 / 6

Start / End Page

  • 909 - 917

PubMed ID

  • 22581550

Pubmed Central ID

  • 22581550

Electronic International Standard Serial Number (EISSN)

  • 1097-4598

International Standard Serial Number (ISSN)

  • 0148-639X

Digital Object Identifier (DOI)

  • 10.1002/mus.23330

Language

  • eng