In particular, trials should have sufficiently large samples, ideally based on formal power calculations, and include appropriately long treatment periods and treatment frequencies.
Based on formal sample size calculations for regression analysis the required number of patients for the validity assessment was established at 50.
The number of patients per treatment group was not based on formal statistical sample-size calculations but was considered adequate to allow for determination of an optimal lipegfilgrastim dose for phase 3 clinical studies.
The proposed verification methodology is based on formal verification methods.
Of note, this sample size was not based on a formal power calculation but on all eligible patients in our database.
The sample size was not based on a formal power calculation, but rather chosen considering conclusive findings in previous studies of comparable size [ 8, 10].
The sample required for this is not based on a formal power calculation but on a pragmatic decision balancing sufficient numbers to be able to identify likely barriers to carrying out a larger scale trial, and cost.
In addition, the sample size was constrained by resources because of the time taken to identify, verify, and collate the 479 discrepancies in 100 trial reports, and was not based on a formal power calculation.
Based on a formal sample size calculation, 41 patients were included, of whom 19 were assigned to receive RTX and 22 to receive DMARD treatment.
As these studies were neither designed to investigate noninferiority nor conducted based on a formal sample size calculation, we cannot be sure whether the findings of no significant difference indicate evidence of equivalence.
