The Northeast ALS Consortium (NEALS) is committed to the cooperative implementation, timely completion, analysis, and reporting of clinical trials and other research studies aimed at improving patient care and disease understanding of Amyotrophic Lateral Sclerosis (ALS) .
Values The NEALS membership is committed to the principles of open scientific communication, peer review, full and open disclosure of potential conflicts of interest, and democratic governance of its organization and activities.
History NEALS is an independent, non-profit consortium of clinical and scientific investigators who collaboratively conduct ALS clinical research at their affiliated institutions. NEALS was founded in 1995 with 9 clinical and academic centers. NEALS membership has grown to over 140 scientific investigators and their staff (including clinicians, clinical evaluators, and research coordinators) at 92 academic clinical centers across the US, Canada, Ireland, and Puerto Rico.
Our Trials The first NEALS clinical research study was the trial of Topiramate in ALS, which was completed in 2002. Since then NEALS has been involved with 17 investigational and observational ALS clinical research studies. NEALS currently has several ALS trials recruiting volunteers.
Structure of NEALS Membership of Scientific Investigators The 92 NEALS sites create a consortium of scientific investigators equipped and ready to perform clinical trials in ALS. The membership undertakes activities to improve ALS clinical research and clinical care; including, standardized training and procedures for implementation of clinical trials, partnerships with leading ALS scientists, and educational programs for investigators.
The NEALS Scientific Advisory Committee advises the organization on development, conduct, analysis, and publication of NEALS trials. NEALS also offer advice on protocol design, biostatistics, and other aspects of trial design for investigators and industry exploring the prospects of conducting a trial in ALS.
Coordination & Data Management Center- MGH NCTU The Neurology Clinical Trials Unit at Massachusetts General Hospital (MGH NCTU) is an academic clinical research organization that acts as the NEALS Coordination & Data Management Center. The NCTU provides NEALS studies with protocol development, project management, data management, biostatistical support, and grant and contract management services.
For more information on the Neurology Clinical Trials Unit at Massachusetts General Hospital please visit their website at http://www.massgeneral.org/research/researchlab.aspx?id=1255
Outcomes & Monitoring Center - SUNY Upstate Medical University SUNY Upstate Medical University acts as the NEALS Outcomes & Monitoring Center. SUNY provides NEALS sites with training on ALS outcome measures. In addition, NEALS employs trained site monitors based at SUNY who conduct site and pharmacy monitoring for all trials. For information about SUNY Upstate Medical University, please contact Marylou Watson at 315-464-5004.
Remaining true to its collaborative efforts, NEALS works with other professional organizations and government and industry sponsors to develop substantive treatments for patients with ALS. The NEALS network of scientific investigators, the Coordination & Data Management Center, and the Outcomes & Monitoring Center create an Academic Contracted Research Organization (ACRO) experienced in developing and conducting multi-center clinical trials in ALS.
For more information on NEALS membership, services, or ALS trials please contact the NEALS Program Manager, Breen Power, at bpower@partners.org. | |