More MS news articles for August 2001

National MS Society Grants $800,000 To Innovative Sylvia Lawry Centre To Compile And Analyze Data On MS Trials

http://www.nationalmssociety.org/Research-2001Aug3.asp

August 3, 2001
 
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Summary:

The National MS Society has just granted $800,000 over the next four years to the MS International Federation (MSIF) to help support the Sylvia Lawry Centre in Munich, Germany, an innovative international collaborative effort to maximize data available from natural history studies and clinical trials of MS therapies.

This multi-million dollar center for MS research was set up under the auspices of the MSIF in February 2001, and is named for the late founder of the National MS Society and the MSIF.

A team of top statisticians and biometricians at the Institute for Medical Statistics and Epidemiology at the Technical University of Munich will collect important data “buried” in past and current clinical trials for MS therapies and in natural history studies of the disease. They will use advanced mathematical and computerized methods to analyze this information and make it available to investigators interested in studying MS.

One of the first efforts will involve analyzing placebo groups from clinical trials in order to create “virtual” placebo groups, to help develop MS treatments more speedily, efficiently and cost-effectively, and avoid the need for people to take inactive substances during clinical trials. 

Details:

The National MS Society has just granted $800,000 over the next four years to the MS International Federation (MSIF) to help support the Sylvia Lawry Centre in Munich, Germany, an innovative international collaborative effort to maximize data available from natural history studies and clinical trials of MS therapies. This multi-million dollar center for MS research was set up under the auspices of the MSIF in February 2001, and is named for the late founder of the National MS Society and the MSIF. 

Background:

In 1998, members of the National MS Society’s Advisory Committee on Clinical Trials of New Agents in MS suggested there are significant amounts of important data “buried” in past and current clinical trials for MS therapies and in studies of the natural history of the disease. The idea was that these data, including information about disease course, response to treatment, and magnetic resonance imaging (MRI) findings, could be mined effectively and used to develop a new understanding of MS and new controls and technologies for future clinical trials. Thus was born the concept for an international MS data center that would gather and analyze this information from investigators and from pharmaceutical companies that have collected such data.

Because of the clear international focus of this concept, the MSIF, under the guidance of its Medical Advisory Board chair, Dr. W. Ian McDonald, and an international steering committee, undertook the development of the full project concept and as well as the effort to gather financial support needed to create the Centre. After a comprehensive bidding process and peer review, the Institute for Medical Statistics and Epidemiology at the Technical University of Munich was chosen as the project site. Albrecht Neiss, PhD, leads the project as its scientific director.

Project:

Dr. Neiss and a team of top statisticians and biometricians, guided by an oversight committee of MS clinicians led by Dr. John Noseworthy (Mayo Clinic, Rochester MN), are collecting data from all major natural history studies and clinical trials of treatments for MS. The team will use advanced mathematical and computerized methods to analyze this information and make data available for analysis to investigators interested in studying MS. The center has already obtained commitments for data collected from thousands of individuals involved in past natural history and clinical trials. Strict attention is being paid to confidentiality of information – no single individual can be identified in the data set. 

One of the first efforts of the Centre will involve analyzing placebo groups from clinical trials – groups of people that take an inactive substance, for comparison with the people actually taking the drug under study. Dr. Neiss and colleagues hope to create “virtual” placebo groups, that is, statistics that describe the natural course of MS. Clinical researchers could then use these statistics in the evaluation of new therapies. This resource could help to develop new treatments for MS more speedily, efficiently and cost-effectively, while avoiding the need for people with MS to take inactive substances during clinical trials.

Among the questions that could be addressed with these data are: Is it possible to predict the clinical course of MS patients using clinical and MRI markers of disease activity, and thus determine whether a new treatment is modifying the predicted course? Does any single MRI measure, or combination of MRI measures and disease activity, predict the future clinical course reliably enough to be safely used as an independent measure of true effectiveness of a treatment?

In addition to the research agenda set by the oversight committee, proposals from independent investigators for studies and data access will also be considered. Because of the unique and valuable nature of this data, the founders hope that the center will ultimately become financially self-sustaining.

Conclusions:

“This Centre is one of the most exciting MS research projects,” commented Dr. McDonald at the first meeting of the Oversight Committee in March 2001. “Without it, future trials of MS drugs are going to be extremely difficult.” The Sylvia Lawry Centre promises to greatly increase our understanding of the natural history of MS, and speed the search for new therapies.