January 6, 2021
Planning for Functional Outcome Measurement
Functional change is at the heart of most innovative approaches to neuromuscular disorders. Scientists and drug developers need to know whether each investigational product will affect the functional decline resulting from a rare neuromuscular disorder. Whether function will be measured as respiratory function, activities of daily living, endurance, strength, or power, planning for how function is measured is critical. Choosing the outcome measure is just the beginning – each trial will need strategies for how sites are selected, equipped, qualified, trained, and supervised as they perform these important tests throughout the study. Carefully managing all the aspects of the functional outcome measures ensures their validity and consistency across sites.
TRiNDS Study Measurements provides specialized neuromuscular expertise to help researchers choose and implement the most appropriate study outcomes. Our experts help researchers select the appropriate outcome measures for the planned study population during protocol design. We create training plans to guide how central trainers and site staff are trained to administer the outcome measures. Our neuromuscular experts help sponsors source the right testing equipment and supplies that sites will need. During the study, we provide central data review to monitor whether site staff are administering and scoring the measures correctly over time. Our team provides refresher trainings and continuing education to study teams to keep their skills current throughout the study. We match our services to the unique needs of every trial sponsor and their sites to maximize data quality without duplication of efforts.
TRiNDS is a contract research organization (CRO) dedicated to conducting rare and neuromuscular disease research. We are currently accepting new clients developing products for rare disease orphan disease, and neuromuscular patient populations. Contact TRiNDS today to request a quote.