Phase 3 clinical trials, the typical final step before a drug gains Food and Drug Administration (FDA) approval, must last long enough to accurately gauge treatment results.
But in the case of a new study on amyotrophic lateral sclerosis (ALS) conducted at Massachusetts General Hospital, there may be different measures that can expedite clinical trials, thus bringing some treatments to market faster.
A new metric, ATLIS (accurate test of limb isometric strength), is better at measuring the long-term effects of treatment than either of two older measures: breathing function or overall function, the study found.
The problem with the two longstanding tests is that the results may show some improvement before ultimately regressing. With the new ATLIS test, patients sit in a sensor-rigged chair that determines their muscle strength. A trial of three or more visits of 100 patients showed readings from ATLIS changed less over time, compared to results from the breathing and overall function assessments.
According to the ALS Association’s website, amyotrophic lateral sclerosis is a disease of the brain and spinal cord that limits a patient’s muscle control. It affects some 20,000 people each year.
