The FDA issued a final guidance Wednesday advising on statistical considerations for proposed changes to the conduct of clinical trials due to COVID-19 that may impact the analysis and interpretation of a trial’s primary or key secondary endpoints. “Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments,” the agency said. The guidance is intended to help ensure that trials conducted during the pandemic will provide interpretable findings with correct statistical quantification of uncertainty.
The NIH plans to invest $25 million over five years in the new Accelerating Leading-edge Science in ALS (ALS2) program. Part of the NIH Common Fund’s High-Risk, High-Reward research program, ALS2 is intended to spur innovative research on amyotrophic lateral sclerosis (ALS). Focused investment in research from a range of scientific disciplines is needed to capitalize on genetic research that recently has provided clues to understanding the disease, according to the NIH. ALS2 will follow a three-pronged approach: adapting emerging tools and technologies from neuroscience and cell biology to identify what causes ALS at the molecular level and how the disease progresses; attracting new talent from a range of scientific disciplines, and examining biological similarities between ALS and motor neuron disease in other neurodegenerative disorders.