Recommendations for myasthenia gravis clinical trials.

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.

journal_name

Muscle Nerve

journal_title

Muscle & nerve

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

doi

10.1002/mus.23330

subject

Has Abstract

pub_date

2012-06-01 00:00:00

pages

909-17

issue

6

eissn

0148-639X

issn

1097-4598

journal_volume

45

pub_type

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