Randomization |
Quality of randomization |
Masking |
Proper evaluation of success |
Allocation Concealment |
Proper evaluation of success |
Withdrawals and Dropouts |
Run-in selection bias Proper ITT and sensitivity analyses |
Baseline data |
Measured before randomization |
Endpoints |
Maximally informative, clinical (not surrogate) endpoints, pre-specified |
Stopping rules |
Account for any interim analysis |
Statistical methods |
Minimal assumptions, adhere to the scale of measurement, pre-specified |
Measures of Variability |
Necessary data table presented |
Address Multiplicity |
Adjust p-values for multiple testing |