The ALS Association
FOR IMMEDIATE RELEASE
Washington, D.C. (August 13, 2013) - The ALS Association is pleased to announce it has awarded $500,000 to the Northeast ALS Consortium (NEALS) to fund new initiatives and ongoing programs that will increase the quality and efficiency of clinical trials for amyotrophic lateral sclerosis (ALS). The grant will support the work of NEALS in its collaboration with The Association’s Translational Research Advancing Therapy (TREAT) ALS program, a diverse portfolio of ALS research to find treatments and a cure for ALS. '
ALS, which is also known as Lou Gehrig’s Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and only one drug approved by the U.S. Food and Drug Administration (FDA) that modestly extends survival.
This is the sixth consecutive year of funding by The Association for NEALS, which is the largest consortium of ALS clinical researchers in the world. “We are very pleased to continue and extend support for ALS clinical trials research through the collaboration between NEALS and TREAT ALS,” said Lucie Bruijn, Ph.D., Chief Scientist for The Association.
New initiatives funded this year include:
--Exploring the feasibility of a centralized Institutional Review Board (cIRB) for NEALS clinical trials. An IRB is responsible for protecting patient safety and autonomy during a clinical trial. Studies have shown that a centralized IRB can perform the same functions while greatly reducing the start-up time for a trial. NEALS will pursue the possibility of establishing a cIRB for its trials, in order to reduce delays in beginning trials for new drugs. They will also pursue efficiencies in contract development and trials site reporting, both important aspects of running efficient clinical trials.
--Videotaping the annual Clinical Research Learning Institute (CRLI) in an effort to reach a broader patient audience. The CRLI is an intensive program dedicated to educating patients and caregivers on clinical research and therapy development while also empowering them to act as advocates for ALS research. Providing web-based access to the program will offer patients and caregivers unparalleled access to this high-quality and actionable information.
--Creation of a Global ALS Patient Identifier. Using technology from the National Institutes of Health, NEALS will create a unique ID for each ALS patient who enters a clinical trial. This will protect patient identity while enhancing research collaboration. Researchers will be able to share data and biofluids without compromising patient privacy.
--Development of NeuroBANKTM, a platform for collaboration, research, education and best clinical practices development utilized by the ALS clinical and research community. NeuroBANK is poised to become central repository for clinical research data in ALS, greatly expanding the ability of researchers to share data and speed research. Samples collected through this resource are available for researchers world-wide.
"The ALS-CRLI has now helped 60 Research Ambassadors to be more effective advocates for ALS Research, thereby empowering them to speed the development of better ALS treatments. The ALS-CRLI program itself keeps getting better and better, thanks in large part to the excellent feedback we get from each graduating class,” said Richard Bedlack, M.D., Ph.D., Duke University.
In addition to these new initiatives, The Association’s support will allow continuation of multiple ongoing projects, including clinical trials recruitment, training of young investigators, and improving the quality of clinical trials through training of both Principal Investigators and Site Investigators.
Funding will also continue to support the ALS Association/NEALS Clinical Trial Expert Line, which offers a full-time staff member available to answer questions and help people navigate through the clinical research information. Help is available by telephone (877-458-0631) during regular business hours, Eastern Standard Time, or by email at firstname.lastname@example.org.
About The ALS Association
The ALS Association is the only national non-profit organization fighting Lou Gehrig’s Disease on every front. By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.alsa.org.