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 ...
Non-inferiority trials have become an essential instrument in clinical research, particularly when the goal is to demonstrate that an experimental treatment is not unacceptably worse than an ...
Ultrahypofractionated radiotherapy demonstrated non-inferiority to conventional fractionation with higher 10-year failure-free survival with similar toxicity profiles in patients with intermediate- or ...
Protocol fidelity and transparency about changes are essential to the credibility of randomised controlled trials In recent ...
ONS-5010 shows non-inferiority to Lucentis at 12 weeks; BLA resubmission planned for Q1 2025, with $20.4M in proceeds expected. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, ...
New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion ...
Novartis NVS reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or ...
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