Dynamic implementation platform for ALS clinical trials

Design for Time-to-Event endpoints

Mortality, 18-month

Summary

Historical assumptions

Modelled mortality rate


                                

                                

Design parameters

Simulation of Time-to-Event designs

Simulated trial

Hypothetical results:

Simulate design

Reference values GLI-2012


The forced vital capacity (FVC) is a key measure for monitoring disease progression in patients with ALS and often used for medical decision-making (e.g. initiation of volume recruiting techniques or NIV). Importantly, study participants are commonly selected based on their FVC. Correct standardization of the FVC is, therefore, essential for both clinicians and researchers. The global lung function 2012 equations (GLI-2012) are the most recent reference values and may improve the value of FVC measurements for ALS patients.1 Nevertheless, due to the non-linear spline functions, the GLI-2012 is difficult to calculate by hand and implement in daily practice.2  

This tool calculates the predicted FVC based on age, race, gender and height using the GLI-2012 reference values.