Clinical Trials and Regulatory Affairs

INTERNATIONAL ADVISORY COMMITTEE ON CLINICAL TRIALS IN MULTIPLE SCLEROSIS

The International Advisory Committee on Clinical Trials in Multiple Sclerosis is jointly supported by the US National Multiple Sclerosis Society (NMSS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The Committee works to provide perspective and guidance in areas of interest to planning and implementation of clinical trials for new agents for the treatment of multiple sclerosis. The Committee works as a whole, in international meetings and consensus-building activities, or through subcommittees and task forces on specific topics.

[Pathology of SPMS
Photo H. Lassmann, University of Vienna ]

Historically, some of the Committee's projects and publications of their outcomes have included:

• Outcomes assessment in MS clinical trials - The "Charleston Meeting" (1995)
• Defining the clinical course of MS (1996)
• MRI for understanding and managing MS (1998)
• Development of the Multiple Sclerosis Functional Composite (1999)
• Diagnostic criteria for MS (2001 and 2005) and differential diagnosis of MS (2008)
• The ethics of placebo-controlled clinical trials in MS (2001 and 2008)
• The impact of available therapies on clinical trial design (2005)
• MRI as a surrogate outcome for MS clinical trials (2008)
• Imaging outcomes for neuroprotection and repair in MS (2009)

Ongoing projects (2009/2010) include a reassessment of MS diagnostic criteria and a consideration of MS clinical rating scales.

REGISTRIES FOR RECENT AND CURRENT MS CLINICAL TRIALS

A number of government, not-for-profit and for-profit organisations provide useful and easily accessible registries for recent and ongoing clinical trials.

You may find the following useful:

• Clinicaltrials.gov is a service of the United States National Health Service.
• Controlled-trials.com is a service of Springer Science+Business Media that provides search capabilities for trials across a number of international registries.
• The Multiple Sclerosis International Federation (MSIF) provides information about trial design, conduct and participation which individuals interested in participating in a clinical trial in MS will find useful.