In late March, many of the MGH ALS Multidisciplinary team attended the ALS Clinical Trial Guidelines workshop outside of Washington, DC, sponsored by the NIH, the International Alliance of ALS/MND, and several other ALS foundations.
Our MGH ALS Multidisciplinary Co-director, James Berry, MD led a session on phase 2 trial designs in ALS, in which I participated. He did a fantastic job in sharing his knowledge with academics, industry leaders and patients from around the world. Our clinical research fellow, Harry Banno, MD, also led a session on preclinical models, which was filled with active discourse. Both Harry and James were great leaders! Katie Nicholson, Sabrina Paganoni, Pat Andres, Alex Sherman also were active participants encouraging dialogues on data sharing, improved outcome measures and innovative recruitment and retention strategies. It was wonderful to see so many of our faculty as leaders in ALS therapy development.
The conference centered on consensus building on aims of early development trials, recruitment, inclusion criteria and desired preclinical packaging. The goal of the conference is to accelerate development of therapies, and have rigorous criteria for moving forward to patients and also from early development stage to later phase 3 trials. A manuscript outlining the consensus from the conference will be published shortly.
- Merit