Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART)

DiscussionIn developing the statistical analysis plan, we had to carefully consider several issues such as multiple testing, estimand specification, interim analyses, and statistical analysis of the repeated measurements of ALS-FRS-R. This analysis plan attempts to balance multiple factors, including minimisation of bias, maximising power and precision, and deriving clinically interpretable summaries of treatment effects.Trial registrationEudraCT Number, 2019 –000099-41. Registered 2 October 2019,https://www.clinicaltrialsregister.eu/ctr-search/search?query=mnd-smartClinicalTrials.gov,NCT04302870. Registered 10 March 2020.
Source: Trials - Category: Research Source Type: clinical trials