Recommendations for myasthenia gravis clinical trials.
Muscle Nerve
; 45(6): 909-17, 2012 Jun.
Article
in En
| MEDLINE
| ID: mdl-22581550
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.
Full text:
1
Database:
MEDLINE
Main subject:
Research Design
/
Clinical Trials as Topic
/
Myasthenia Gravis
Type of study:
Clinical_trials
/
Guideline
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Muscle Nerve
Year:
2012
Type:
Article
Affiliation country:
United States