As you all are, we too are closely monitoring the impact of COVID-19 on the HEALEY ALS Platform Trial timelines and operations. The bottom line is this: we are committed to beginning the trial as soon and as safely as we can. What exactly that will look like is very much in flux these days as we adapt to the ever changing COVID-19 reality. As patients are at the center of everything we do, we are hosting a webinar on April 8th to provide as many details as is possible. If you have questions before then, please send them to HealeyCenterforALS@mgh.harvard.edu and we will do our best to address them in the webinar.
Please join us for a conversation about the HEALEY ALS Platform Trial on Wednesday, April 8 at 3:00 pm.
Stay safe and well.Click here to register
March Progress Report: Successful Investigator Meeting and IRB Approval
The Sean M. Healey & AMG Center for ALS at Mass General held the HEALEY ALS Platform Trial Investigator Meeting on March 12-13, 2020. Just prior to the investigator meeting, the HEALEY ALS Platform Trial received central IRB approval for the Master Protocol and all three of the first trial regimens. Approximately 250 attendees participated in the meeting, including trial organizers, staff from the 54 participating sites, representatives from the HEALEY ALS Platform Trial patient advisory committee, our three industry partners, and from TackleALS, The ALS Association, the Muscular Dystrophy Association and ALS One. Due to the COVID-19 outbreak the meeting was held remotely via videoconference, a change that met with remarkably positive feedback.
Site investigators and coordinators actively participated in our remote training meeting and are excited to begin enrollment in the trial. All of us are following the news of COVID-19 and responding to COVID-19 developments within healthcare. And at the same time, study teams continue to work intently toward site activation for this trial. This is an exceptional testament of the commitment and resourcefulness of our entire ALS community.
The successful Investigator Meeting and initial approval from the central IRB are both key milestones bringing us closer to launching the HEALEY ALS Platform Trial. Our goal remains the same as it has been since we first envisioned the trial: to have all sites ready for activation as soon as possible, so that when we can safely enroll participants, our progress will be rapid and efficient.
For more information, please feel free to contact us at HealeyCenterforALS@mgh.harvard.edu.