Expanding eligibility criteria for early-phase ALS clinical trials could benefit both patients and therapeutic progress, according to experts. Currently, 60% of ALS patients are excluded from clinical trials by the time they are diagnosed, which has ethical and drug development implications. Angela Genge, chief medical officer at QurAlis, believes that expanding eligibility is necessary to allow more ALS patients to potentially benefit from experimental treatments and help drug developers get a truer sense of how well those treatments work. The current inclusion criteria for trials selects for faster-progressing patients who tend to receive a diagnosis more quickly, making them eligible for enrollment.
Heather McKenzie, senior editor at BioSpace, suggests broadening access to clinical trials beyond stringent inclusion criteria can provide benefits like furthering ALS biomarker data which could drive accelerated diagnoses and inform drug development. While there is no easy way to determine inclusion/exclusion criteria for ALS trials, investigators are working toward a robust stratification model that is predictive of speed of progression to include everyone in the study population while defining a priority analysis population. Sabrina Paganoni, co-director of Massachusetts General Hospital’s Neurological Clinical Research Institute said that inclusion and exclusion criteria should be