The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims ...
A randomized double-blind trial of 288 patients aged 3 to 19 found oliceridine 0.08 mg/kg non-inferior to sufentanil 0.4 ...
A study has been reported investigating whether 'stopping' beta-blockers, which have been taken for many years after a myocardial infarction, 'does not lead to significantly worse outcomes than ...
Please provide your email address to receive an email when new articles are posted on . Noninferiority trials test whether a new treatment is not less efficacious than an already approved therapy.
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LUCIA did not achieve the primary endpoint of statistical non-inferiority in mean change in BCVA versus on-label aflibercept control, despite demonstrating visual improvement – – Key secondary ...
Functional impairments, fatigue, and pain in newly diagnosed solid-tumors: Retrospective path analysis.
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