The FSHD Society announces that it has signed a memorandum of understanding to enter into a 3-year agreement to enable the expansion of the international facioscapulohumeral muscular dystrophy (FSHD) Clinical Trial Research Network (CTRN).
FSHD is a hereditary muscle-damaging condition that affects an estimated one out of 8,000 people, or nearly one million men, women, and children worldwide. There is currently no drug to treat or cure FSHD.
The CTRN was formed to create an infrastructure of clinics with expertise in FSHD to hasten therapeutic development by ensuring site training of key personnel, streamlining regulatory oversight and data capture, validating novel clinical outcome measures, and refining clinical trial strategies, a media release from FSHD Society explains.
Currently the network hosts the Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD study (ReSolve), an 18-month observational study following 220 individuals with FSHD. The network was initially financed with seed funding from the FSHD Society, as well as other non-profits, and has since been awarded $1.2MM in support from the Muscular Dystrophy Association.
The current CTRN encompasses a total of 11 sites, with eight sites in the United States and three sites in Europe. The central coordinating center is housed at the University of Kansas Medical Center, and the data and statistical coordinating center at the University of Rochester Medical Center.
Under the new agreement, the FSHD Society will provide KUMC with additional infrastructure support and allow it to expand the CTRN by up to four additional sites.
“With the prospect of a growing number of FSHD clinical trials on the horizon, it will be critical for the CTRN to have the capacity and bandwidth to not only carry out the existing research studies but also successfully recruit and participate in clinical trials,” says Mark Stone, President and CEO of the FSHD Society, in the release.
“We are grateful to the FSHD Society and like-minded organizations that have made it possible for the network to form and carry out studies to help bridge the gaps in clinical trial readiness.
“We are grateful to the FSHD Society and like-minded organizations that have made it possible for the network to form and carry out studies to help bridge the gaps in clinical trial readiness,” adds Jeffrey Statland, MD, associate professor of neurology and co-director of the CTRN.
“The additional sites will ensure that the CTRN will be able to meet the goal of trial preparedness, and ensure well-trained FSHD clinical centers.”
[Source(s): FSHD Society, PRWeb]