This week a $3 million commitment was made by The ALS Association to the first platform trial for ALS. The platform trial will be taking place at the Sean M. Healey & AMG Center for ALS at Mass General in collaboration with the Barrow Neurological Institute and the Northeast ALS Consortium (NEALS). A “platform trial” is a clinical trial in which multiple treatments are tested and evaluated simultaneously. The Association’s commitment is $1 million per year for 3 years.
“This platform trial will significantly speed efficacy trials for ALS research, and is a major advancement for ALS research,” said Calaneet Balas, President, and CEO of The ALS Association. “In addition to supporting the HEALEY ALS Platform Trial, we will be working to ensure the rest of the research pipeline is moving fast enough to keep up. We are delighted to be partnering with Dr. Merit Cudkowicz and her team on this project.”
The platform trial model will greatly accelerate therapy development, allowing investigators to test more drugs, increase patient access to trials, and reduce the cost by quickly and efficiently evaluate the effectiveness of multiple therapies. This trial mode has already been proven successful in the cancer field. New treatments will be added to the trial as they become available which will decrease the gap in time from identification of an exciting therapy to testing. Having a shared infrastructure, common data & sample collecting processes, and centralized governance within the platform trial will help save time and money and led to more operational efficiencies.
“Working closely together, we will bring new therapies forward faster for people with ALS,” said Cudkowicz. “The platform trial builds on previous ALS Association supported research on many new ALS targets and trial innovations. The HEALEY ALS Platform Trial initiative can only succeed with the support and involvement of the entire ALS community. We look forward to ongoing partnerships with people and families with ALS, all ALS foundations, our colleagues in the NEALS Consortium, industry partners and regulatory agencies,” Cudkowicz added.
This funding from The ALS Association will directly support numerous parts of the platform trial. The following will directly benefit from this funding: the Clinical and Data Coordination Center activities at Mass General, the Biomarker Development Endpoint Engine, and the Monitoring and Outcome Measures Core at Barrow Neurological Institute.
The ALS Association will become an integral part of the Foundations and Benefactors Committee responsible for advising on study progress, data sharing, budget matters, fundraising, patient recruitment/retention and variety of other scientific and operational topics. In addition, the trial will be supported by the enrollment of patients at ALS Association Certified Centers of Excellence, Recognized Treatment Centers, and other affiliated centers.
This award to the Healey Center builds on a long relationship The ALS Association has had with Massachusetts General Hospital, Dr. Cudkowicz, and other researchers. The Association has committed over $9 million since 2010 to ALS researchers at Massachusetts General Hospital.