However, the findings of our study, based on a non-randomized design, call for further studies, such as similar analyses of larger and more recent databases, longitudinal studies for a long-term period, and randomized clinical trials for confirmation.
Therefore, the findings of our study, based on a non-randomized design, call for further studies, such as similar analyses of larger databases, prospective population-based studies, and randomized clinical trials, for confirmation.
The findings of our study, based on a non-randomized design, call for further studies, such as similar analyses of larger international databases or randomized clinical trials for confirmation.
Regulatory agencies require multicentre trials for confirmation of efficacy in order to prevent unintentional or conscious bias, outlier outcomes or other idiosyncratic site effects from significantly influencing overall results.
52 Improved patient adherence may be a potential benefit of exenatide once monthly (EQM), owing to greater convenience of administration, 53, 54 although this advantage remains unproven and will require prospective Phase III trials for confirmation.
However, according to the package insert of alectinib, both Vysis FISH and ALK iAEP have to be performed before patients can start alectinib therapy, although FISH was performed in the trial only for confirmation of IHC screening results and the two tests were almost concordant with each other.
Thus, the requirement of two replicate trials for regulatory confirmation of statistical superiority has evolved [ 7].
Although the data from those studies above all indicated potential activity for VEGF-TKIs in combination with selected chemotherapies, phase III trials were necessary for confirmation.
Three trials of confirmation experiments for each response have been performed at optimal setting process parameters, and average values have been reported.
Further research, including a multicenter trial, would be beneficial for confirmation of our outcomes.
