June 26, 2007
Research Update — from ALSA’s National Office
Network of Clinical Investigators Stands Ready for ALS Trials
Roberta Friedman, Ph.D., Research Department Information Coordinator
[Quick Summary: A network of clinical investigators is in place and ready to coordinate clinical testing of promising compounds for ALS, once these are identified.]
The ALS Association, through its TREAT ALS initiative, has put in place a partnership with the North East ALS Consortium (NEALS) to provide a network of clinical investigators that will be ready to test promising compounds in patients with ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease) and provide opportunities for training of newer investigators to participate in clinical trials for ALS.
TREAT ALS (Translational Research Advancing Therapy for ALS) is a drug discovery program and clinical trials process that accelerates discovery and testing of clinical candidates. The TREAT ALS/NEALS Clinical Trials Network will expedite multi-center trials of compounds identified through the TREAT ALS drug discovery program or any other compounds that appear to hold promise for the disease.
The network will facilitate training of ALS centers including centers certified by The Association, and the existing trials network of NEALS will provide rapid translation of promising laboratory results into clinical trials. The ability to partner effectively with government, industry, and contract research organizations (CROs) is a key aspect of the TREAT ALS/NEALS Clinical Trials Network.
“Having a clinical trials investigator network in place is an important part of the TREAT ALS program, and we are pleased that the NEALS group is able to lend their expertise to train other centers. This will accelerate trials of ALS candidate treatments,” said Lucie Bruijn, Ph.D., science director and vice president of The ALS Association.
Bruijn added, “Through TREAT ALS several biotech companies have approached The ALS Association for support in the development of novel compounds or ideas for drug development in ALS. With this new partnership, leaders in the field can provide the necessary expertise to help move these opportunities forward.”
NEALS Consortium (www.alsconsortium.org)
This group of academic investigators, formed in 1995, has extensive experience in ALS clinical trials with 65 clinical centers in North America that participate. Co-chairs are Merit Cudkowicz, M.D., and Jeremy Shefner, M.D., Ph.D., both experts at caring for ALS patients and leaders in design and methods for trials of compounds in neurodegenerative disorders. The eight members of the NEALS executive committee are elected biannually from among the investigator members and meet regularly. A scientific advisory board is in place whose members are actively involved in the study of ALS disease mechanisms and treatment development.
“NEALS has several meetings each year where members review possible therapies to test, and this provides opportunity to collaborate on research studies,” noted Cudkowicz. The ALS Association’s support of NEALS and partnership in a clinical trial network is “innovative and timely.” She added, “This support will allow training of new ALS trial sites and improve access for people with ALS to new therapies throughout the U.S. It will speed up the development of new therapies by improving efficiency. We look forward to continuing to work closely with The Association and the TREAT ALS initiative.”
Promising Pipeline
NEALS has pipelines of compounds through contacts with biotechnology companies, and through the collaboration of NEALS members who are prominent basic scientists with labs focused on drug discovery, NEALS investigators have also validated many outcome measures and pioneered streamlined and efficient new clinical trial designs. NEALS has an established coordination and data management center and has built and validated a state-of-the-art electronic data capture and trial management system. Many centers certified by The Association are already members of NEALS.
Shefner said, “As more drugs pass through the pipeline and require clinical evaluation, it will be critical to have sufficient trained clinical sites that can participate in trials. The NEALS collaboration with The Association will provide a mechanism to train new sites and will provide the infrastructure necessary to rapidly design and implement clinical trials.”
“NEALS has a history of inclusiveness,” Shefner added, “and we look forward to welcoming many new sites to our group and to including them in future trials. In addition to enhancing training, this initiative will aid in further development of high quality data acquisition and management and will ensure that all study measures are accurately and reliably performed. I believe that the Treat ALS/ NEALS Clinical Trial Initiative will be a significant benefit to the ALS community.”
New Steering Committee under TREAT ALS
The Association will establish a steering committee to advise on trials to be conducted through this new network and will work with NEALS on design of trials, selection of participating sites, and training appropriate for each trial. Funding will support these activities, through the TREAT ALS initiative.
Participation will not be limited to centers already certified by The Association. Two clinical trials are already under consideration as pilot studies for the TREAT ALS Clinical Trials Network. Any promising clinical trial can be funded independent of or take advantage of this new resource to expedite discovery of effective ALS therapy.
Refer to the The ALS Association’s Web site under the research tab for further information about TREAT ALS.
