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The
China SCI Network will initially be funded
from an account set up at The University
of Hong Kong. Over the coming year, we will
set up a separate foundation to support
the China SCI Network.
The
goals of the network are as follows:
-
Establish a spinal cord injury clinical
trial network in China, by coordinating
the clinical trial activities of major
spinal cord injury centers. The Network
will provide funding to the clinical trial
centers so that they can rigorously collect
outcome data and carry out FDA (US) compliant
clinical trials in China.
-
Train the centers to carry out standardized
neurological examinations, specifically
the American Spinal Injury Association
or International Spinal Cord Injury Classification
System. This will be done in workshops
in March and October of each year.
-
Fund the Clinical Trials Centre at Hong
Kong University to organize and coordinate
the clinical trials. The HKU CTC will
collect the data, site-visit the centers
regularly to ensure that they meet criteria,
and analyze the data.
- Hold
two meetings a year to train personnel
in each center, to promote communication
amongst the centers, and also for the
centers to decide what therapies they
want to test, and to design rigorous clinical
trials. The second meeting will be the
International Symposium of Spinal Cord
Injury Therapies and Trials. The first
of these meetings will be in Hong Kong
and subsequent meetings will be hosted
by one of the five other "nodes": Beijing,
Guangzhou, Shanghai, Xian, and Zhengzhou
(Henan province). More centers will be
added as necessary and possible.
During
the first year (2005), the network will
collect data on 600 subjects with spinal
cord injury (100 subjects per node). We
will use this data to assess intra- and
inter-center variability, to estimate the
number of subjects needed to show significant
results. In the second year, we will carry
out one clinical trial randomizing approximately
1200 subjects to treatment arms that will
be decided in October 2005 at the First
International SCI Therapies and Trials Symposium.
In the third year, we hope to expand the
capability of the network, eventually to
randomize 6000 subjects per year in four
clinical trials.
In
addition to training clinicians from each
other of the Network centers, we will establish
a workshop in Hong Kong where we will train
at least one or two investigators every
year to do preclinical studies in their
centers. We would like the centers to participate
in the entire therapy development approach
ranging from animal studies to human.
Wise
Young
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The
Objectives

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The
China Spinal Cord Injury Network
The
China Spinal Cord Injury Network will apply these therapies
in systemic clinical trials.
China
is taking the leadership in bringing spinal cord injury therapies
to clinical trial by establishing the China Spinal Cord Injury
Network (China SCI Network).
The
Network will initially have eight nodes:
Beijing
Guangzhou
Hong Kong
Kunming
Ningbo
Shanghai
Xian
Zhengzhou
HKU's
Clinical Trials Centre will co ordinate the testing, with
responsibility for training and organizing clinicians who
deliver therapy and evaluate patients, to ensure international
standards are met.
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