http://www.nationalmssociety.org/Headlines-SylviaLawryCntr.asp
August 1, 2001
The National MS Society has just
granted $800,000 over the next 4 years to the MS International Federation
(MSIF; website: http://www.ifmss.org.uk/)
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 MSI.
“This Centre is one of the most exciting
MS research projects,” commented Dr. W. Ian McDonald, chair of the MSIF’s
Medical Advisory Board. “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.
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 Dr. McDonald and
an international steering committee, undertook the development of the full
project concept, 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.
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 describing the natural course of MS.
Clinical researchers could then use these statistics in the evaluation
of new therapies. This resource could help 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.
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.