Recommendations for myasthenia gravis clinical trials

Muscle & Nerve
Michael BenatarTask Force on MG Study Design of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America

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.

References

Jun 21, 1993·Annals of the New York Academy of Sciences·R S TindallK Hall
Jul 21, 1998·Annals of the New York Academy of Sciences·R J BarohnW W Bryan
Jan 19, 2000·Clinical Immunology : the Official Journal of the Clinical Immunology Society·P ChristadossC Deng
Mar 15, 2000·Muscle & Nerve·J M Lindstrom
Mar 10, 2001·Clinical Pharmacology and Therapeutics·UNKNOWN Biomarkers Definitions Working Group.
Mar 27, 2001·Muscle & Nerve·R H PaulJ M Goldstein
Mar 29, 2002·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·L PaduaP Tonali
Oct 4, 2002·Muscle & Nerve·Gil I WolfeUNKNOWN Myasthenia Gravis-IVIG Study Group
Nov 1, 2003·Annals of the New York Academy of Sciences·Donald B SandersJanice M Massey
Jun 24, 2005·The New England Journal of Medicine·Bart KeymeulenLucienne Chatenoud
Nov 16, 2005·Archives of Neurology·Philippe GajdosUNKNOWN Myasthenia Gravis Clinical Study Group
Dec 7, 2007·The Journal of Immunology : Official Journal of the American Association of Immunologists·Yuefang ZhouHenry J Kaminski
Jun 24, 2008·Annals of the New York Academy of Sciences·Donald B Sanders, Zaeem A Siddiqi
Jun 24, 2008·Annals of the New York Academy of Sciences·Julie Rowin
Jul 22, 2008·Muscle & Nerve·Ted M BurnsUNKNOWN Muscle Study Group
Aug 1, 2008·Journal of Neuroimmunology·Sofie P M JanssenMario Losen
Aug 5, 2008·Journal of Neuroimmunology·Inmaculada B AbanUNKNOWN Mgtx Advisory Committee
Aug 13, 2008·Muscle & Nerve·Larry L MullinsUNKNOWN Muscle Study Group
Nov 20, 2008·Muscle & Nerve·Ted M BurnsUNKNOWN Muscle Study Group
May 15, 2009·Clinical Pharmacology and Therapeutics·A D BarkerL J Esserman
May 5, 2010·Neurology·Ted M BurnsUNKNOWN MG Composite and MG-QOL15 Study Group
Jun 29, 2010·Muscle & Nerve·Ted M Burns
Mar 25, 2011·The New England Journal of Medicine·Liewei WangRichard M Weinshilboum
Jan 3, 2013·Annals of the New York Academy of Sciences·Michael BenatarRabi Tawil

❮ Previous
Next ❯

Citations

Mar 1, 2012·Zeitschrift für Rheumatologie·R W C JanzenUNKNOWN Arzneimittelkommission der deutschen Ärzteschaft, Berlin
Nov 26, 2013·Current Neurology and Neuroscience Reports·Sui H WongGordon T Plant
Oct 22, 2014·Expert Review of Clinical Immunology·Majed AlabdaliVera Bril
Jun 21, 2013·Disability and Rehabilitation·Alberto RaggiRenato Mantegazza
Jul 17, 2015·Muscle & Nerve·Michael BenatarUNKNOWN Muscle Study Group (MSG)
May 4, 2013·Revue neurologique·M BouchikhA Benosman
Sep 16, 2015·Muscle & Nerve·Carlo AntozziRenato Mantegazza
Mar 5, 2016·Journal of Neurology·Alberto RaggiRenato Mantegazza
Dec 26, 2015·Journal of Neurology·Sophie BinksJacqueline Palace
Jun 23, 2015·Journal of the Neurological Sciences·Anna Rostedt PungaTanel Punga
Dec 21, 2012·Annals of the New York Academy of Sciences·Fulvio BaggiDonald Sanders
Jan 3, 2013·Annals of the New York Academy of Sciences·Mamatha PasnoorUNKNOWN Muscle Study Group
Jan 3, 2013·Annals of the New York Academy of Sciences·Michael BenatarRabi Tawil
Jan 3, 2013·Annals of the New York Academy of Sciences·Henry J KaminskiGary Cutter
Oct 9, 2012·Muscle & Nerve·Hai-Feng LiYan-Chen Xie
Jan 17, 2015·Experimental Neurology·Anna Rostedt PungaMichael Benatar
Dec 30, 2014·Orphanet Journal of Rare Diseases·Carolina BarnettVera Bril
Oct 27, 2016·Clinical Neurophysiology : Official Journal of the International Federation of Clinical Neurophysiology·Maarika Liik, Anna Rostedt Punga
Nov 20, 2016·Muscle & Nerve·Robert H P De MeelJan J G M Verschuuren
Dec 7, 2016·Pharmacogenetics and Genomics·Lara ColleoniDimos Kapetis
Oct 21, 2016·Muscle & Nerve·Donald B Sanders, Janice M Massey
Dec 3, 2016·Arquivos de neuro-psiquiatria·Ezequiel Fernandes OliveiraLuis Vicente Franco Oliveira
Sep 6, 2017·Journal of Clinical Neurophysiology : Official Publication of the American Electroencephalographic Society·Åsa AmandussonAnna R Punga
Jun 23, 2018·Expert Review of Neurotherapeutics·Shuhui WangHenry J Kaminski
Apr 18, 2018·Neurology·Karen HewettUNKNOWN BEL115123 Study Group
Mar 8, 2018·Neurology. Neuroimmunology and Neuroinflammation·Carl Johan MolinAnna Rostedt Punga
Dec 13, 2019·Journal of Neurology·Jakob RathFritz Zimprich
Oct 9, 2012·Muscle & Nerve·Donald B SandersGary R Cutter
Sep 12, 2020·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Sawsan AlabbadHenry J Kaminski
Sep 26, 2020·Dementia & Neuropsychologia·Annelise AyresMaira Rozenfeld Olchik
Jun 18, 2017·Frontiers in Neurology·Yanchen XieHenry J Kaminski
Jul 27, 2017·Arquivos de neuro-psiquiatria·Ezequiel Fernandes OliveiraLuis Vicente Franco Oliveira
Jan 30, 2018·Annals of the New York Academy of Sciences·Jeffrey T GuptillPushpa Narayanaswami
Aug 28, 2020·Frontiers in Neurology·Laura O'ConnorAnna Rostedt Punga
Nov 11, 2017·Annals of the New York Academy of Sciences·Anna Rostedt Punga, Tanel Punga
Jan 31, 2020·Frontiers in Immunology·Karissa L Gable, Jeffrey T Guptill
Aug 3, 2019·Metabolomics : Official Journal of the Metabolomic Society·Derrick BlackmoreWalter Maksymowych
Mar 21, 2020·Frontiers in Immunology·Liis SabreAnna Rostedt Punga
Feb 22, 2017·Journal of Clinical Neuromuscular Disease·Srikanth Muppidi

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
Alberto RaggiRenato Mantegazza
European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies
K OhtaM Ohta
The Journal of Clinical Investigation
Bianca M Conti-FineHenry J Kaminski
© 2021 Meta ULC. All rights reserved