http://www.nationalmssociety.org/Research-2001Aug3.asp
August 3, 2001
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.
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